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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 2 of 39

Device	Model / Reference	Registries	Class	Status
iTotal® PS	RPS010190002	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HAH01028MD01	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS020080003	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS020122S01	FDA UDI	Class II	Active
iTotal Identity CR	RCR020110014	FDA UDI	Class II	Active
iDuo® Femoral Kit	RBK101111201	FDA UDI	Class II	Unknown
iTotal® Patella Sizer	1080-528	FDA UDI	Class II	Active
iTotal® CR iPoly XE™ Insert Kit	RCR020110001	FDA UDI	Class II	Unknown
Identity Imprint Knee Replacement System	TPS030125S01	FDA UDI	Class II	Active
iTotal Identity CR	RCR020150014	FDA UDI	Class II	Active
iTotal Identity CR	RCR010000M04	FDA UDI	Class II	Active
Identity Imprint Porous CR	TCR-302-T01S-01	FDA UDI	Class II	Active
Identity Imprint	TCR-023-086S-01	FDA UDI	Class II	Active
Identity Imprint	TCR-033-185N-01	FDA UDI	Class II	Active
iTotal Identity CR	TCR-000-SPEC02	FDA UDI	Class II	Active
iTotal Identity CR	RCR020000J04	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030147S01	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HDL060F22S01	FDA UDI	Class II	Active
Conformis Hip System	1080-628	FDA UDI	Class I	Active
Identity Imprint Knee Replacement System	TCR030082S01	FDA UDI	Class II	Active
iTotal® Identity Cruciate Retaining Knee Replacement System	RCR010140004	FDA UDI	Class II	Active
Identity Imprint	TCR-033-062N-01	FDA UDI	Class II	Active
Actera Hip Stem	HES-034-07UH-01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR030062N01	FDA UDI	Class II	Active
Identity Imprint	TCR-033-081S-01	FDA UDI	Class II	Active
iTotal® CR iPoly™ Insert Kit	RCR010100003	FDA UDI	Class II	Active
Identity Imprint	TCR-033-073N-01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR020073S01	FDA UDI	Class II	Active
iTotal Identity CR	RCR010200R01	FDA UDI	Class II	Active
Actera	HES-034-11CS-01	FDA UDI	Class II	Active
iTotal® Poly Impactor Tip	1080-549	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HAH01032LG01	FDA UDI	Class II	Active
iTotal® Patella Trial	1080-512	FDA UDI	Class II	Active
Itotal Identity Impactor Handle	1080-212	FDA UDI	Class I	Active
Identity Imprint	TCR-033-064S-01	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TPS030087S01	FDA UDI	Class II	Active
iTotal® Identity Cruciate Retaining Knee Replacement System	TCR010000D01	FDA UDI	Class II	Active
iTotal® Identity Cruciate Retaining Knee Replacement System	RCR010120G01	FDA UDI	Class II	Active
Conformis Hip System	HCC032B05701	FDA UDI	Class II	Active
iTotal Identity Posterior Stabilized Knee Replacement System	RPS010120003	FDA UDI	Class II	Active
iTotal PS	RPS-020-210012	FDA UDI	Class II	Active
iTotal® Hip Replacement System	HAR000S15901	FDA UDI	Class II	Active
Hip Broach Handle, Gen 2, Offset Right	1080-697	FDA UDI	Class I	Active
Calcar Planer Adapter Drop-in	1080-700	FDA UDI	Class I	Active
iTotal Identity CR Knee Replacement System (with CS Insert)	RCR023140J01	FDA UDI	Class II	Active
iTotal® Identity Cruciate Retaining Knee Replacement System	RCR010170M01	FDA UDI	Class II	Active
Conformis Hip System	HBS033C16101	FDA UDI	Class II	Active
Itotal Identity Impactor Adapter	1080-213	FDA UDI	Class II	Active
Identity Imprint Knee Replacement System	TCR030081S01	FDA UDI	Class II	Active
Conformis Hip System	1080-639	FDA UDI	Class I	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.