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Sign in to claim this brandAesculap Implant Systems, Inc.
US
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)
Page 8 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Modification To: S4 Spinal System | K090657 | FDA 510(k) | Class II | Active |
| Columbus Total Knee System As | K071220 | FDA 510(k) | Class II | Active |
| Ennovate Cervical Spinal and Occiput System | K213871 | FDA 510(k) | Class II | Active |
| Vega Knee System | K140452 | FDA 510(k) | Class II | Active |
| Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | K153700 | FDA 510(k) | Class II | Active |
| Metha Hip System | K071916 | FDA 510(k) | Class II | Active |
| S4 Spinal System | K123939 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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 |