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

Biopro, Inc. — Predicate Candidate Screening

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

113 daysmedian FDA review time

292 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K163627	Shotel Ankle Arthrodesis Nail System	Biopro, Inc.	2017-09-14	266	0
K162674	BioPro Foot Plating Systems	Biopro, Inc.	2017-06-16	263	0
K132510	BIOPRO - INFINITY PLATE ANCHOR SYSTEM	Biopro, Inc.	2013-10-24	73	0
K130298	BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM	Biopro, Inc.	2013-06-18	131	0
K121973	BIOPRO HEMI-EDGE TOE SYSTEM	Biopro, Inc.	2012-10-30	117	0
K100761	BIOPRO POLAR HEAD	Biopro, Inc.	2010-12-03	261	1
K101030	MODIFICATION TO HBS HEADLESS BONE SCREW	Biopro, Inc.	2010-06-03	51	0
K090208	BIOPRO FEMORAL HEADS	Biopro, Inc.	2009-05-22	114	3
K083490	BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-1868	Biopro, Inc.	2009-03-18	113	0
K082705	BIOPRO BIPOLAR HEAD, MODELS 18130-18152	Biopro, Inc.	2008-12-15	90	0
K081149	BIOPRO GO-EZ SCREW	Biopro, Inc.	2008-08-05	105	0
K072298	BIOPRO MEMORY STAPLE, MODELS 18062-18073	Biopro, Inc.	2007-10-29	73	0
K061798	BIOPRO MEMORY STAPLE	Biopro, Inc.	2006-08-21	56	0
K061089	MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17	Biopro, Inc.	2006-06-20	63	0
K052596	MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,	Biopro, Inc.	2005-11-15	55	0
K043542	BIOPRO TARA FEMORAL RESURFACING COMPONENT	Biopro, Inc.	2005-05-18	146	0
K041595	TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,1	Biopro, Inc.	2004-11-12	151	0
K041936	BIOPRO SUBTALAR IMPLANT	Biopro, Inc.	2004-09-08	51	0
K011459	WUJIN #3 FEMORAL BONE PLATE	Biopro, Inc.	2001-08-07	88	0
K011460	WUJIN #3 TIBIAL BONE PLATE	Biopro, Inc.	2001-08-07	88	0
K010149	WUJIN #3 FEMORAL NAIL	Biopro, Inc.	2001-04-17	90	0
K001046	BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS	Biopro, Inc.	2000-06-08	69	0
K990821	PROVIDENCE CUP SYSTEM	Biopro, Inc.	1999-04-29	49	0
K960467	POWDER FREE LATEX EXAMINATION GLOVE	Biopro, Inc.	1996-05-24	115	0
K922500	PSL TOTAL HIP REPLACEMENT SYSTEM	Biopro, Inc.	1994-01-07	590	0
K925682	BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED	Biopro, Inc.	1994-01-07	427	0
K922841	BIOPRO MODULAR TIBIAL TRAY	Biopro, Inc.	1993-09-21	466	0
K920145	BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM	Biopro, Inc.	1992-10-15	276	0
K912641	BIOPRO ZIRALLOY MODULAR FEMORAL HEADS	Biopro, Inc.	1991-11-27	166	1
K911378	TOWNLEY GREAT TOE JOINT	Biopro, Inc.	1991-11-22	239	0
K904448	TOWNLEY TOTAL KNEE (TTK)	Biopro, Inc.	1991-07-17	292	0
K910352	BIOPRO METAL BACKED CEMENTED ACETABULAR CUP	Biopro, Inc.	1991-06-13	135	0
K904207	BIOPRO TRINITY ACETABULAR CUP	Biopro, Inc.	1991-01-04	114	0
K895886	BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM	Biopro, Inc.	1989-12-01	57	1
K894604	BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT	Biopro, Inc.	1989-11-17	120	0
K890044	BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE	Biopro, Inc.	1989-11-06	305	0
K882869	TOWNLEY COX COMB ACETABULAR COMPONENT	Biopro, Inc.	1988-10-14	95	0
K882146	BIOPRO PC FEMORAL HIP COMPONENT	Biopro, Inc.	1988-08-29	98	0
K874099	REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE	Biopro, Inc.	1987-12-14	67	0
K872535	BIOPRO FEMORAL HIP COMPONENT	Biopro, Inc.	1987-08-26	61	0
K872856	BIOPRO 32MM BALL	Biopro, Inc.	1987-08-17	27	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