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Aesculap Implant Systems, Inc.

Last updated May 23, 2026

What Aesculap Implant Systems, Inc. makes

The company manufactures reusable orthopaedic instruments and spinal fixation hardware, including positioning tools for prosthesis implantation, bone screws for internal spinal fixation, and surgical trays and racks. Examples include the activL® spinal bone screw system, the ARCADIUS XP C instrument tray, and the MODULIFT bone awl and screwdriver.

These devices are regulated under FDA Class I and Class II classifications, with authorisation records maintained in the FDA’s 510(k) and UDI databases. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Aesculap Implant Systems, Inc. manufacture?

Aesculap Implant Systems, Inc. specializes in reusable orthopaedic instruments and spinal fixation hardware. Their products include positioning instruments for prosthesis implantation, reusable surgical trays and racks, bone screws for internal spinal fixation, and tools like bone awls and screwdrivers. Examples include the activL® spinal bone screw system, ARCADIUS XP C instrument trays, and MODULIFT bone awls and screwdrivers.

Where is Aesculap Implant Systems, Inc. based?

The company is headquartered in the United States. While the exact location isn’t specified, its devices are designed and manufactured with U.S. regulatory standards in mind, particularly for FDA compliance.

Which regulatory registries list Aesculap Implant Systems, Inc.’s devices?

Aesculap Implant Systems, Inc.’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track authorisation records for Class I and Class II devices, ensuring transparency in compliance with U.S. medical device regulations.

How are Aesculap Implant Systems, Inc.’s devices classified under FDA regulations?

The company’s devices fall under FDA Class I and Class II classifications. Class I generally includes low-risk devices like reusable surgical instruments, while Class II covers moderate-risk items such as spinal fixation hardware, which may require special controls to ensure safety and effectiveness. Classification determines regulatory oversight and authorisation requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
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Catalogue (357)

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Device	Model / Reference	Registries	Class	Status
Orthopilot 2 Total Hip Arthroplasty (tha) Version 3.0	K072899	FDA 510(k)	Class II	Active
Excia Total Hip System M An Ml Femoral Stem	K092143	FDA 510(k)	Class II	Active
Modification To: Metha Hip System	K083495	FDA 510(k)	Class II	Active
Excia Total Hip System	K150062	FDA 510(k)	Class II	Active
ENNOVATE Spinal System	K162134	FDA 510(k)	Class II	Active
Excia Total Hip System	K140915	FDA 510(k)	Class II	Active
VEGA Knee System	K143106	FDA 510(k)	Class II	Active
Biospine Vbr System	K110864	FDA 510(k)	Class II	Active
Laminoplasty Plating System	K090354	FDA 510(k)	Class II	Active
Aesculap Orthopilot Next Generation	K141694	FDA 510(k)	Class II	Active
Aesculap Peek Xp Spinal Implant System	K132421	FDA 510(k)	Class II	Active
Metha Hip System	K112682	FDA 510(k)	Class II	Active
Aesculap Resorbable Pin, Model Fr735	K070178	FDA 510(k)	Class II	Active
Plasmafit Acetabular Cup And Vitelene Insert	K122783	FDA 510(k)	Class II	Active
Columbus Total Knee System Mios Cr/Ps Tibial Tray	K071499	FDA 510(k)	Class II	Active
Columbus Total Knee System As Columbus Revision Knee System Enduro Knee System	K120955	FDA 510(k)	Class II	Active
Aesculap Sibd Xp Spinal System	K111122	FDA 510(k)	Class II	Active
Laminoplasy Plating System	K103284	FDA 510(k)	Class II	Active
Ais Modulift Vbr System	K133802	FDA 510(k)	Class II	Active
Columbus Revision Knee System	K122985	FDA 510(k)	Class II	Active
S4 Cervical Spinal and Occiput Systems	K151938	FDA 510(k)	Class II	Active
Biolox Option Ceramic Femoral Head And Metha Xl Heads	K090299	FDA 510(k)	Class II	Active
Columbus Revision Knee System	K083772	FDA 510(k)	Class II	Active
Orthopilot Next Generation, Model Fs101-Fs106	K080547	FDA 510(k)	Class II	Active
Univation	K131167	FDA 510(k)	Class II	Active
S4 Spinal System	K130291	FDA 510(k)	Class II	Active
AIS Odontoid Fracture Fixation System	K142707	FDA 510(k)	Class II	Active
Vega Knee System	K121879	FDA 510(k)	Class II	Active
Quintex Cervical Plating System	K121801	FDA 510(k)	Class II	Active
S4 Spinal System	K112551	FDA 510(k)	Class II	Active
Search Evolution (lc) Total Knee System (plasmapore)	K070981	FDA 510(k)	Class II	Active
Orthopilot Next Generation-Uka Software, Model Fs210	K090375	FDA 510(k)	Class II	Active
Hto Plating System	K102505	FDA 510(k)	Class II	Active
Metha Short Stem Hip System Xl Femoral Head	K082146	FDA 510(k)	Class II	Active
Mili (minimally Invasive Lumbar Implant) System	K083004	FDA 510(k)	Class II	Active
Aesculap Peek Intervertebral Body Fusion System: A Space, Cespace, Prospace, T-Space	K071983	FDA 510(k)	Class II	Active
Metha Short Stem Hip System	K080584	FDA 510(k)	Class II	Active
Vega Knee System	K101281	FDA 510(k)	Class II	Active
S4c Navigation Instruments	K130887	FDA 510(k)	Class II	Active
Aesculap Implant Systems Sibd Spinal System	K100802	FDA 510(k)	Class II	Active
Ais Modulift Vbr System	K142150	FDA 510(k)	Class II	Active
Aesculap OrthoPilot Next Generation	K153396	FDA 510(k)	Class II	Active
S4 Cervical Occipital Plate Spinal System	K100147	FDA 510(k)	Class II	Active
Metha Short Stem Hip System; Modular Hip System; Excia Hip System	K081973	FDA 510(k)	Class II	Active
Enduro Knee System	K101815	FDA 510(k)	Class II	Active
S4 Spinal System	K071945	FDA 510(k)	Class II	Active
Univation Unicondylar Knee System	K081293	FDA 510(k)	Class II	Active
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System	K150544	FDA 510(k)	Class II	Active
ENNOVATE Spinal System	K210963	FDA 510(k)	Class II	Active
S4 Spinal System	K123352	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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Authorities

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FDA Recalls (73)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Aesculap Implant Systems, Inc. has 73 recall records spanning from October 10, 2007, to July 20, 2023, with statuses including completed, open, classified, and terminated. The reasons cited involve potential detachment of surgical needles, unauthorized market release of a system prior to FDA clearance, malfunctions in implant deployment or robotic systems, mechanical failures such as fractures or insufficient clamping force in spinal fixation components, and issues with bleeding, electrode insulation abrasion, improper threading in revision instruments, valve pressure misalignment, and rod deformation in spinal systems.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 20, 2023	Z-2518-2023	—	open, classified	Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the visual field is obscured.
May 18, 2023	Z-2146-2023	—	open, classified	Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
Mar 21, 2023	Z-1569-2023	—	open, classified	Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
Feb 23, 2023	Z-1430-2023	—	open, classified	Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
Jul 15, 2022	Z-1638-2022	—	open, classified	Potential for the incorrect screw to be included in the package.
Jul 14, 2022	Z-1516-2022	—	terminated	Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
Oct 25, 2021	Z-1410-2022	—	terminated	Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Jun 30, 2021	Z-1405-2022	—	terminated	Customized coronal rod benders may deform the implant when used with the spinal system devices.
Jun 30, 2021	Z-1406-2022	—	terminated	Customized coronal rod benders may deform the implant when used with the spinal system devices.
Apr 16, 2021	Z-2578-2021	—	terminated	Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Apr 16, 2021	Z-2579-2021	—	terminated	Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Mar 19, 2021	Z-2515-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Mar 19, 2021	Z-2513-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Mar 19, 2021	Z-2514-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Mar 19, 2021	Z-2512-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Mar 19, 2021	Z-2509-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Mar 19, 2021	Z-2516-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Mar 19, 2021	Z-2510-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Mar 19, 2021	Z-2511-2021	—	terminated	Malfunction- loosening of the implant resulting in a potential revision surgery
Feb 19, 2021	Z-1409-2022	—	completed	Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
Nov 18, 2020	Z-1429-2022	—	terminated	Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
Sep 8, 2020	Z-1444-2022	—	terminated	Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Sep 8, 2020	Z-1448-2022	—	terminated	Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Sep 8, 2020	Z-1443-2022	—	terminated	Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Sep 8, 2020	Z-1445-2022	—	terminated	Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Sep 8, 2020	Z-1447-2022	—	terminated	Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Sep 8, 2020	Z-1446-2022	—	terminated	Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Jul 13, 2020	Z-1428-2022	—	terminated	Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
Apr 1, 2020	Z-1482-2022	—	completed	Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Apr 1, 2020	Z-1481-2022	—	completed	Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Jan 21, 2020	Z-1479-2020	—	terminated	Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Jan 21, 2020	Z-1481-2020	—	terminated	Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Jan 21, 2020	Z-1482-2020	—	terminated	Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Jan 21, 2020	Z-1480-2020	—	terminated	Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Jan 21, 2020	Z-1478-2020	—	terminated	Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Nov 12, 2019	Z-1391-2022	—	completed	Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Oct 1, 2019	Z-1449-2022	—	terminated	Packaging seal integrity not validated resulting in a lack of sterility assurance.
Sep 25, 2019	Z-1383-2022	—	terminated	Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Aug 7, 2019	Z-2496-2019	—	terminated	possibility of the sterility batch being insufficiently sterilized
Aug 7, 2019	Z-2497-2019	—	terminated	possibility of the sterility batch being insufficiently sterilized
Feb 16, 2018	Z-1358-2018	—	terminated	The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Feb 16, 2018	Z-1359-2018	—	terminated	The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Jan 22, 2018	Z-1291-2018	—	terminated	Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Jan 22, 2018	Z-1290-2018	—	terminated	Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.
Sep 21, 2017	Z-0809-2018	—	terminated	A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.
Sep 8, 2017	Z-0624-2018	—	terminated	The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.
Sep 5, 2017	Z-0620-2018	—	terminated	ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Sep 5, 2017	Z-0619-2018	—	terminated	ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Sep 5, 2017	Z-0621-2018	—	terminated	ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Sep 1, 2017	Z-0623-2018	—	terminated	The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
Aug 10, 2017	Z-0591-2018	—	terminated	The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
Mar 28, 2017	Z-2089-2017	—	terminated	Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Mar 28, 2017	Z-2087-2017	—	terminated	Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Mar 28, 2017	Z-2088-2017	—	terminated	Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Mar 7, 2017	Z-1814-2017	—	terminated	Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
Jan 9, 2017	Z-1218-2017	—	terminated	Generators may have a faulty component which could impact the proper functioning of the device.
Oct 28, 2016	Z-0947-2017	—	terminated	Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
Aug 1, 2016	Z-0316-2017	—	terminated	There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.
Jul 25, 2012	Z-2333-2012	—	terminated	There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
Jul 12, 2012	Z-2114-2012	—	terminated	The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree tria
Mar 7, 2012	Z-1934-2012	—	terminated	Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
Feb 21, 2012	Z-1793-2012	—	terminated	During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.
Jan 24, 2012	Z-1455-2012	—	terminated	The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.
Oct 10, 2007	Z-0439-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0436-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0438-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0440-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0441-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0445-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0442-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0437-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0443-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment
Oct 10, 2007	Z-0444-2008	—	terminated	Sterility (package integrity) Compromised: Device package damaged during shipment