Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Conformis, Inc. — Predicate Candidate Screening

60 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

78 daysmedian FDA review time

156 days90th percentile

60clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232426	Identity Imprint Porous Cruciate Retaining (CR) Knee Replace	Conformis, Inc.	2023-09-08	28	0
K223316	Identity Imprint Porous Total Knee Replacement System, Ident	Conformis, Inc.	2023-07-21	266	0
K230846	iTotal Identity Knee Replacement System; Identity Imprint Kn	Conformis, Inc.	2023-07-17	111	0
K231233	Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS	Conformis, Inc.	2023-05-26	28	1
K231178	ACTERA™ hip system	Conformis, Inc.	2023-05-23	27	0
K230844	Identity Imprint Cruciate Retaining (CR) Knee Replacement Sy	Conformis, Inc.	2023-04-27	30	0
K221104	Actera™ hip system	Conformis, Inc.	2022-08-04	112	1
K221404	Identity Imprint Knee Replacement System (including Identity	Conformis, Inc.	2022-07-26	71	0
K221059	Identity Imprint Knee Replacement System (including Identity	Conformis, Inc.	2022-05-10	29	0
K213389	Identity Imprint Cruciate Retaining (CR) Knee Replacement Sy	Conformis, Inc.	2021-11-10	26	0
K212411	Identity Imprint Knee Replacement System (including Identity	Conformis, Inc.	2021-09-23	51	0
K210809	iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement S	Conformis, Inc.	2021-05-12	56	0
K210191	Identity Imprint Knee Replacement System	Conformis, Inc.	2021-05-06	101	1
K203421	Triathlon AS-1	Conformis, Inc.	2021-04-19	150	0
K210252	iTotal Identity Cruciate Retaining (CR) Knee Replacement Sys	Conformis, Inc.	2021-02-17	19	0
K203447	iTotal Identity Cruciate Retaining (CR) Total Knee Replaceme	Conformis, Inc.	2020-12-22	29	0
K202484	Cordera Hip System	Conformis, Inc.	2020-09-24	24	2
K201023	iTotal® Identity Posterior Stabilized Knee Replacement Syste	Conformis, Inc.	2020-06-16	57	0
K193105	iUni Unicondylar Knee Replacement System, iDuo Bicompartment	Conformis, Inc.	2020-03-13	126	0
K192198	Conformis Hip System	Conformis, Inc.	2019-11-06	85	0
K190904	Conformis BeneFIT Hip System	Conformis, Inc.	2019-08-28	142	1
K190562	iTotal Identity Cruciate Retaining Knee Replacement System	Conformis, Inc.	2019-08-08	156	0
K180906	Conformis iTotal Cruciate Retaining (CR) Knee Replacement Sy	Conformis, Inc.	2018-05-16	40	0
K170226	iTotal Family Reusable Instrument Tray	Conformis, Inc.	2017-10-25	273	0
K162719	iTotal® Hip Replacement System	Conformis, Inc.	2017-06-14	258	0
K161668	ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replaceme	Conformis, Inc.	2016-07-15	29	1
K161366	ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement Sys	Conformis, Inc.	2016-06-14	28	0
K153721	iTotal Cruciate Retaining (CR) Knee Replacement System	Conformis, Inc.	2016-03-25	88	0
K160025	iTotal Posterior Stabilized (PS) Knee Replacement System, iT	Conformis, Inc.	2016-03-07	61	0
K153217	ConforMIS iTotal Posterior Stabilized Knee Replacement Syste	Conformis, Inc.	2016-01-07	63	0
K152704	iTotal Posterior Stabilized Knee Replacement System, iTotal	Conformis, Inc.	2015-10-21	30	0
K142404	iTotal Posterior Stabilized (PS) Knee Replacement System	Conformis, Inc.	2014-12-11	106	2
K142161	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOT	Conformis, Inc.	2014-11-14	100	5
K140833	ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2014-06-30	89	0
K140423	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2014-05-27	98	1
K133560	ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM	Conformis, Inc.	2014-03-28	128	0
K133256	ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT	Conformis, Inc.	2014-01-09	78	6
K132640	IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2013-12-05	104	3
K131467	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2013-07-18	58	0
K131019	ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2013-05-24	42	0
K122870	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2013-01-14	117	0
K122991	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2012-12-20	85	0
K122033	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2012-09-27	78	0
K121974	CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2012-09-06	63	0
K120316	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2012-04-19	78	0
K113378	CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SY	Conformis, Inc.	2012-02-15	91	0
K120068	CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)	Conformis, Inc.	2012-02-03	25	0
K112780	CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SY	Conformis, Inc.	2011-12-15	80	0
K111916	CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2011-09-29	85	0
K103117	ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM	Conformis, Inc.	2011-01-07	78	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda