Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Plus Orthopedics — Predicate Candidate Screening

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

69 daysmedian FDA review time

228 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K032126	PROMOS SHOULDER	Plus Orthopedics	2004-01-08	182	0
K033763	MODIFICATION TO SLIM GLIDING NAIL SYSTEM	Plus Orthopedics	2003-12-18	16	0
K032709	MODULAR PLUS HIP STEM	Plus Orthopedics	2003-09-23	21	0
K032548	IP-XS COMPRESSION NAIL SYSTEM	Plus Orthopedics	2003-09-10	23	0
K032215	VKS/TC-PLUS REVISION KNEE	Plus Orthopedics	2003-08-08	18	0
K032052	UC-PLUS SOLUTION UNICONDYLAR KNEE	Plus Orthopedics	2003-07-25	23	1
K031165	PLUS ORTHOPEDICS CEMENTED HIP STEM	Plus Orthopedics	2003-06-06	53	0
K030971	MODIFICATION TO MODULAR PLUS REVISION STEM	Plus Orthopedics	2003-04-24	27	0
K024134	UNI HIP STEM	Plus Orthopedics	2003-01-15	30	0
K023667	RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE	Plus Orthopedics	2002-12-24	54	0
K023416	MODIFICATION TO VKS KNEE SYSTEM	Plus Orthopedics	2002-11-08	28	0
K022204	VKS KNEE SYSTEM	Plus Orthopedics	2002-10-18	105	4
K022120	MPF ACETABULAR CUP GENERATION 2	Plus Orthopedics	2002-07-24	23	0
K021714	RT-PLUS PE INSERT CLAMP	Plus Orthopedics	2002-06-21	28	0
K020298	GALILEO CAS/NAV TKR SYSTEM	Plus Orthopedics	2002-05-20	112	1
K021178	SL-PLUS LATERALIZED STEM	Plus Orthopedics	2002-05-14	29	0
K020240	SLIM GLIDING NAIL SYSTEM	Plus Orthopedics	2002-02-22	30	1
K013340	RT-PLUS KNEE ADDITIONAL COMPONENTS	Plus Orthopedics	2001-12-20	72	0
K011836	MPF ACETABULAR CUP	Plus Orthopedics	2001-09-07	87	0
K011719	PLUS CANCELLOUS BONE SCREWS	Plus Orthopedics	2001-07-02	28	0
K011258	TC-PLUS POROUS FEMORAL COMPONENTS	Plus Orthopedics	2001-05-24	30	0
K011288	TC-PLUS POROUS TIBIAL COMPONENTS	Plus Orthopedics	2001-05-24	27	0
K003504	RT-PLUS MODULAR CEMENTED KNEE COMPONENTS	Plus Orthopedics	2001-05-11	179	0
K003274	LPC-PLUS ACETABULAR CUP	Plus Orthopedics	2001-04-06	170	0
K994146	EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP	Plus Orthopedics	2000-12-11	369	0
K000666	TC-PLUS SOLUTION KNEE	Plus Orthopedics	2000-10-13	228	9
K001942	SL-PLUS AND SLR-PLUS STEMS	Plus Orthopedics	2000-07-25	29	0
K993874	BOFOR REVISION COUP	Plus Orthopedics	2000-06-05	203	0
K994126	MODULAR-PLUS REVISION STEM	Plus Orthopedics	2000-05-04	149	0
K992154	BICON-PLUS ACETABULAR COMPONENTS	Plus Orthopedics	2000-04-06	286	0
K992153	PE-PLUS ACETABULAR CUP	Plus Orthopedics	1999-09-23	90	0
K990261	PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)	Plus Orthopedics	1999-08-27	212	0
K982859	UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM	Plus Orthopedics	1999-07-30	351	1
K990309	PLUS FRACTURE HEAD PROSTHESIS	Plus Orthopedics	1999-03-15	42	0
K982447	PLUS BIPOLAR PROSTHESIS COCRMO	Plus Orthopedics	1998-11-25	133	0
K974409	FRIEDL GLIDING NAIL SYSTEM	Plus Orthopedics	1998-02-19	87	0
K973077	PLUS-FIT ACETABULAR CUP	Plus Orthopedics	1997-11-13	87	0
K973098	COMPRESSION CERCLAGE GUNDOLF CCG-GF	Plus Orthopedics	1997-10-27	69	0

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