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

Howmedica, Inc. — Predicate Candidate Screening

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

87 daysmedian FDA review time

301 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K984251	XIA SPINE SYSTEM	Howmedica, Inc.	1999-02-24	89	0
K984202	HOWMEDICA HUMERAL INTERCALARY SYSTEM	Howmedica, Inc.	1999-02-05	73	0
K984305	ZETA MULTIZONE LOCKING NAIL SYSTEM	Howmedica, Inc.	1999-02-01	61	0
K983885	BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES	Howmedica, Inc.	1999-01-29	88	0
K983358	G/K SFN AND STN LOCKING NAILS	Howmedica, Inc.	1998-11-18	55	0
K982463	EXTRACRANIAL RADIOTHERAPY SYSTEM	Howmedica, Inc.	1998-09-30	77	0
K982248	HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS,	Howmedica, Inc.	1998-08-31	66	0
K980813	RELIANCE LONG STEM FEMORAL COMPONENTS	Howmedica, Inc.	1998-06-26	115	0
K981283	ROGACHEFSKY DISTAL RADIUS PLATES	Howmedica, Inc.	1998-06-10	63	0
K980843	EXETER INTRAMEDULLARY BONE PLUG	Howmedica, Inc.	1998-06-02	90	0
K980239	PARTNERSHIP CALCAR FEMORAL COMPONENTS	Howmedica, Inc.	1998-04-16	83	0
K974720	HOWMEDICA(R) FULLY THREADED SCREWS	Howmedica, Inc.	1998-03-13	85	0
K974289	EPI-UNION PLATING SYSTEM	Howmedica, Inc.	1998-02-12	90	0
K973982	ORBITAL RECONSTRUCTION PLATES	Howmedica, Inc.	1998-01-12	84	0
K974054	DISTAL CENTRALIZER, EXETER II HIP SYSTEM	Howmedica, Inc.	1997-12-23	57	3
K972228	MERIDIAN TITANIUM FEMORAL STEMS	Howmedica, Inc.	1997-12-05	175	0
K973484	CHIN DISTRACTOR	Howmedica, Inc.	1997-12-02	78	0
K973321	HOFFMANN II COMPACT PERIARTICULAR CLAMP	Howmedica, Inc.	1997-11-20	77	0
K972928	KERBOULL CROSS	Howmedica, Inc.	1997-11-03	87	0
K972361	V40 ZIRCONIA FEMORAL HEADS	Howmedica, Inc.	1997-09-23	90	0
K963940	EXETER MESH	Howmedica, Inc.	1997-02-13	135	0
K961498	RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A	Howmedica, Inc.	1997-02-06	294	0
K961916	HOFFMANN II CARBON CONNECTING ROD	Howmedica, Inc.	1996-08-01	76	0
K961497	PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM	Howmedica, Inc.	1996-06-28	71	0
K961496	R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM	Howmedica, Inc.	1996-06-28	71	0
K955806	HOWMEDICA BIOABSORBABLE PIN	Howmedica, Inc.	1996-02-15	55	0
K950115	LUHR(R) TITANIUM BURR HOLE COVERS	Howmedica, Inc.	1995-04-10	89	0
K946026	HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS	Howmedica, Inc.	1995-03-20	98	0
K940307	HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT	Howmedica, Inc.	1995-01-19	360	1
K945093	P.C.A. E-SERIES HIP- CEMENTLESS USE	Howmedica, Inc.	1995-01-19	94	0
K935913	HOWMEDICA SENTRY S TOTAL HIP SYSTEM	Howmedica, Inc.	1994-12-15	370	0
K936127	HOWMEDICA PREMIUM FEMORAL COMPONENT	Howmedica, Inc.	1994-10-26	307	1
K936126	HOWMEDICS DRG FEMORAL COMPONENT	Howmedica, Inc.	1994-10-20	301	0
K936132	EXETER ALL PLASTIC ACETABULAR COMPONENT	Howmedica, Inc.	1994-06-14	173	0
K940286	GAMMA LOCKING NAIL MODIFICATION	Howmedica, Inc.	1994-03-14	63	0
K936124	HOWMEDICA MONOTUBE T-CONNECTOR	Howmedica, Inc.	1994-02-22	61	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