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Conformis, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 600 Research Dr, Wilmington, MA, 01887
Website: conformis.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 781-345-9001
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004153240
DUNS Number: 808821883

Catalogue (1943)

Page 39 of 39

Device	Model / Reference	Registries	Class	Status
Cordera Hip System	K202484	FDA 510(k)	Class II	Active
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System	K210252	FDA 510(k)	Class II	Active
Actera™ hip system	K221104	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System, Itotal Posterior Stabilized (ps) Knee Replacement System	K142161	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System	K122033	FDA 510(k)	Class II	Active
Conformis Bicompartmental Knee Repair System	K053488	FDA 510(k)	Class II	Active
Conformis Metal Backed Tibial Component	K072368	FDA 510(k)	Class II	Active
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)	K161668	FDA 510(k)	Class II	Active
Iduo Bicompartmental Knee Repair System	K093513	FDA 510(k)	Class II	Active
Itotal Cr Knee Replacement System	K094050	FDA 510(k)	Class II	Active
iTotal Identity Cruciate Retaining Knee Replacement System	K190562	FDA 510(k)	Class II	Active
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System	K193105	FDA 510(k)	Class II	Active
Conformis Itotal Cr Knee Replacement System (krs)	K120068	FDA 510(k)	Class II	Active
ConforMIS iTotal Posterior Stabilized Knee Replacement System	K153217	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (c) Knee Replacement System	K131019	FDA 510(k)	Class II	Active
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts	K232426	FDA 510(k)	Class II	Active
Conformis BeneFIT Hip System	K190904	FDA 510(k)	Class II	Active
Iuni Unicondylar Knee Replacement System	K132640	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System	K122991	FDA 510(k)	Class II	Active
iTotal Posterior Stabilized (PS) Knee Replacement System	K142404	FDA 510(k)	Class II	Active
Conformis Itotal Cruciate Retaining (cr) Knee Replacement System	K113378	FDA 510(k)	Class II	Active
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)	K161366	FDA 510(k)	Class II	Active
iTotal® Hip Replacement System	K162719	FDA 510(k)	Class II	Active
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)	K221404	FDA 510(k)	Class II	Active
Conformis Uni-Condylar Knee System	K072586	FDA 510(k)	Class II	Active
Identity Imprint Knee Replacement System	K210191	FDA 510(k)	Class II	Active
ACTERA™ hip system	K231178	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System	K131467	FDA 510(k)	Class II	Active
Conformis Iuni Unicondylar Knee Replacement System	K121974	FDA 510(k)	Class II	Active
iTotal Family Reusable Instrument Tray	K170226	FDA 510(k)	Class II	Active
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System	K152704	FDA 510(k)	Class II	Active
Modification To: Conformis Iuni Unicondylar Knee Repair System	K092441	FDA 510(k)	Class II	Active
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System	K230846	FDA 510(k)	Class II	Active
Unicondylar Knee Repair System / Conformis Ucd	K043570	FDA 510(k)	Class II	Active
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement	K203447	FDA 510(k)	Class II	Active
Conformis Hip System	K192198	FDA 510(k)	Class II	Active
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System	K223316	FDA 510(k)	Class II	Active
Itotal Posterior Stabilized (ps) Knee Replacement System	K140833	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System	K122870	FDA 510(k)	Class II	Active
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System	K213389	FDA 510(k)	Class II	Active
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)	K221059	FDA 510(k)	Class II	Active
Conformis Itotal Cruciate Retaining (cr) Knee Replacement System	K112780	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System	K103117	FDA 510(k)	Class II	Active

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FDA Recalls (37)

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

Date	Recall No.	Class	Status	Reason
Mar 25, 2025	Z-1569-2025	—	open, classified	The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Mar 11, 2024	Z-1591-2024	—	open, classified	Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Jun 16, 2023	Z-2405-2023	—	open, classified	30mm screws were labeled as 25mm screws.
Nov 14, 2022	Z-1133-2023	—	open, classified	Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
Feb 22, 2022	Z-0899-2022	—	completed	Incorrect tibial base plate implant packaged in kit
Sep 21, 2020	Z-0475-2021	—	terminated	Incorrect hip components were provided in kits.
Jul 20, 2020	Z-2849-2020	—	terminated	Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Feb 3, 2020	Z-1627-2020	—	terminated	A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Feb 3, 2020	Z-1628-2020	—	terminated	A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Oct 25, 2019	Z-0672-2020	—	terminated	Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Aug 22, 2019	Z-0064-2020	—	terminated	Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Aug 22, 2019	Z-0063-2020	—	terminated	Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Mar 29, 2019	Z-1775-2019	—	terminated	Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Mar 29, 2019	Z-1776-2019	—	terminated	Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Jan 4, 2019	Z-1079-2019	—	terminated	The labeling of the boxes and sterile pouches did not match the contents.
Dec 3, 2018	Z-1108-2019	—	terminated	The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Oct 16, 2018	Z-0731-2019	—	terminated	The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Jul 24, 2017	Z-0600-2018	—	terminated	Implant kit mislabeled
Oct 31, 2016	Z-0991-2017	—	terminated	iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Oct 18, 2016	Z-0658-2017	—	terminated	Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Jan 28, 2016	Z-1070-2016	—	terminated	Incorrect femoral component distributed
Aug 31, 2015	Z-0142-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0144-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0145-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0148-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0138-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0141-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0139-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0143-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0140-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0146-2016	—	terminated	May contain small amounts of ethylene glycol residue
Aug 31, 2015	Z-0147-2016	—	terminated	May contain small amounts of ethylene glycol residue
Nov 19, 2014	Z-0581-2015	—	terminated	Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Jul 17, 2012	Z-2222-2012	—	terminated	Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
Apr 23, 2009	Z-1624-2009	—	terminated	Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
Apr 23, 2009	Z-1623-2009	—	terminated	Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
Apr 23, 2009	Z-1622-2009	—	terminated	Microscopic cracks potential for pre-mature revisions in patients implanted with the system.