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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 38 of 39

Device	Model / Reference	Registries	Class	Status
iTotal Identity CR Knee Replacement System (with CS Insert)	RCR023160L01	FDA UDI	Class II	Active
Itotal Identity Extension Wrench Handle	1080-210	FDA UDI	Class II	Active
iTotal® CR iPoly™ Insert Kit	RCR010000E02	FDA UDI	Class II	Active
iTotal® CR iPoly® Insert Kit	RCR010110013	FDA UDI	Class II	Active
iDuo® Patella	PAB011350802	FDA UDI	Class II	Active
Itotal Ipoly Xe 32mm X 8mm Cemented Oval Patella Implant	POV021320801	FDA UDI	Class II	Active
iTotal® CR iPoly® Insert Kit	RCR010150013	FDA UDI	Class II	Active
iTotal® PS iPoly® XE Insert Kit	RPS020220002	FDA UDI	Class II	Active
iTotal® CR Tibial Tray Impactor Tip	1080-536	FDA UDI	Class II	Active
Itotal Identity Round Patella Head Sizer 38-41-44mm	1080-218	FDA UDI	Class II	Active
iTotal® CR iPoly® Insert Kit	RCR010000B13	FDA UDI	Class II	Active
iTotal® PS iPoly® XE Insert Kit	RPS020180002	FDA UDI	Class II	Active
Itotal Drill Bit 3mm Diameter	1080-233	FDA UDI	Class II	Active
Itotal Ipoly Xe 38mm X 9mm Cemented Oval Patella Implant	POV021380901	FDA UDI	Class II	Active
iUni® Femoral Kit	RUK101111202	FDA UDI	Class II	Active
iTotal® PS iPoly® Insert Kit	RPS010210001	FDA UDI	Class II	Active
iTotal Identity CR Knee Replacement System (with CS Insert)	TCR013090D01	FDA UDI	Class II	Active
iTotal® CR iPoly XE™ Insert Kit	RCR020000I01	FDA UDI	Class II	Unknown
iTotal Identity CR Knee Replacement System (with CS Insert)	TCR013140J01	FDA UDI	Class II	Active
Cordera Hip System (Stainless Steel) Trial Neck 132deg, 36.5mm	1080-654	FDA UDI	Class II	Active
iTotal Identity CR Knee Replacement System (with CS Insert)	RCR013090D11	FDA UDI	Class II	Active
iTotal® CR iPoly® XE Insert Kit	RCR020100013	FDA UDI	Class II	Active
iTotal® CR iPoly™ Insert Kit	RCR010120003	FDA UDI	Class II	Active
iDuo® iPoly™ Insert Kit	RBK010120002	FDA UDI	Class II	Active
iTotal® CR iPoly XE™ Insert Kit	RCR020120001	FDA UDI	Class II	Unknown
Itotal Ipoly Xe 44mm X 11mm Cemented Oval Patella Implant	POV021441101	FDA UDI	Class II	Active
iTotal® CR iPoly® XE Insert Kit	RCR020090013	FDA UDI	Class II	Active
Itotal Uhmwpe 44mm X 11mm Cemented Oval Patella Implant	POV011441101	FDA UDI	Class II	Active
iTotal® iPoly XE™ Patella	PAT021320601	FDA UDI	Class II	Active
Angel Wing Resection Guide	1080-537	FDA UDI	Class I	Active
Actera Femoral Broach, Size 06	1080-681	FDA UDI	Class II	Active
iTotal Identity CR Knee Replacement System (with CS Insert)	RCR013110F01	FDA UDI	Class II	Active
iUni® iPoly™ Insert Kit	RUK010100001	FDA UDI	Class II	Unknown
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)	K210809	FDA 510(k)	Class II	Active
iTotal Cruciate Retaining (CR) Knee Replacement System	K153721	FDA 510(k)	Class II	Active
Conformis, Inc. Total Knee Repair System	K052687	FDA 510(k)	Class II	Active
Triathlon AS-1	K203421	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System	K140423	FDA 510(k)	Class II	Active
Conformis Iuni Unicondylar Knee Replacement System	K111916	FDA 510(k)	Class II	Active
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System	K180906	FDA 510(k)	Class II	Active
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS	K231233	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)	K212411	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining Knee Replacment System	K133560	FDA 510(k)	Class II	Active
Conformis Metal Backed Tibial Component(mbt)	K063432	FDA 510(k)	Class II	Active
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System	K160025	FDA 510(k)	Class II	Active
iTotal® Identity Posterior Stabilized Knee Replacement System	K201023	FDA 510(k)	Class II	Active
Conformis Total Knee Repiar System (itotal) Tibial Component: 6.0 Mm Thickness	K080936	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo Bicompartmental Knee Repair System	K133256	FDA 510(k)	Class II	Active
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert	K230844	FDA 510(k)	Class II	Active
Itotal Cruciate Retaining (cr) Knee Replacement System	K120316	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.