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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 11 of 39

Device	Model / Reference	Registries	Class	Status
iTotal® Hip Replacement System	HDL060E22L01	FDA UDI	Class II	Active
Identity Imprint Porous CR	POV-012-4110-01	FDA UDI	Class II	Active
Actera	HES-034-0001-01	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS010100003	FDA UDI	Class II	Active
Triathlon AS-1 PS Box Chisel Cementless Instrumentation Kit	6556C00801	FDA UDI	Class II	Active
Itotal Identity Femoral Cut Guide Small	1080-223	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030085N01	FDA UDI	Class II	Active
iTotal® CR iPoly® XE Insert Kit	RCR020070013	FDA UDI	Class II	Active
Identity Universal Reusable Instrument Lid Trifecta	1080-125	FDA UDI	Class I	Active
iTotal® Hip Replacement System	HDL060B00F01	FDA UDI	Class II	Active
Actera Hip Stem	HES-034-03CS-01	FDA UDI	Class II	Active
Identity Imprint	TCR-033-143N-01	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	TPS020060001	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS020184S01	FDA UDI	Class II	Active
Actera Hip Trial Neck, Reusable Size 10-11-12 High Offset	1080-695	FDA UDI	Class II	Active
Conformis Hip System	1080-623	FDA UDI	Class I	Active
Conformis Hip System	1080-117	FDA UDI	Class II	Unknown
iTotal Identity Posterior Stabilized Knee Replacement System	TPS010070001	FDA UDI	Class II	Active
Identity Imprint	TCR-023-121S-01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS101F03N01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030067S01	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HDL060D20F01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR020104S01	FDA UDI	Class II	Active
iTotal Identity CR	RCR020000A14	FDA UDI	Class II	Active
Conformis Hip System	1080-578	FDA UDI	Class I	Active
Identity Imprint	TCR-030-183N-01	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HAR000S24901	FDA UDI	Class II	Active
Cordera Hip System Radel Liner Impactors 32mm	1080-656	FDA UDI	Class II	Active
Conformis Hip System	1080-633	FDA UDI	Class I	Active
iTotal® Hip Replacement System	HAR000S26401	FDA UDI	Class II	Active
Identity Imprint	TCR-033-125N-01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR020144S01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030084N01	FDA UDI	Class II	Active
Triathlon AS-1 PS Box Chisel CS insert Cementless Instrumentation Kit	6556C00601	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HAR000S26301	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS010170003	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR020123S01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR030142N01	FDA UDI	Class II	Active
iTotal Identity CR	RCR020170004	FDA UDI	Class II	Active
Conformis Hip System	1080-602	FDA UDI	Class I	Active
Identity Imprint Knee Replacement System	TPS020143S01	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS020070003	FDA UDI	Class II	Active
iTotal® Identity Cruciate Retaining Knee Replacement System	TCR010000A01	FDA UDI	Class II	Active
iTotal® CR iPoly™ Insert Kit	RCR010000D02	FDA UDI	Class II	Active
iTotal Identity CR	RCR010190004	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS010200013	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS020165S01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS020084S01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS301T04N01	FDA UDI	Class II	Active
iTotal CR	RCR-020-060003	FDA UDI	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.