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

Howmedica Corp. — Predicate Candidate Screening

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

77 daysmedian FDA review time

274 days90th percentile

373clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983528	MICRO DYNAMIC MESH	Howmedica Corp.	1998-12-23	76	0
K983404	TYPE 3 FEMORAL COMPONENTS	Howmedica Corp.	1998-12-22	85	1
K980926	DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATI	Howmedica Corp.	1998-12-16	280	0
K980925	DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION	Howmedica Corp.	1998-12-16	280	0
K980632	DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION	Howmedica Corp.	1998-12-11	295	0
K980626	DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION	Howmedica Corp.	1998-12-11	296	0
K983419	HOFFMANN II MIAMI POST	Howmedica Corp.	1998-11-25	57	0
K982958	ZETA MULTIZONE LOCKING NAIL SYSTEM	Howmedica Corp.	1998-11-20	88	0
K982873	ZETA MULTIZONE SCN LOCKING NAIL	Howmedica Corp.	1998-10-21	68	0
K982531	HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM	Howmedica Corp.	1998-10-16	88	0
K982670	CONTEMPORARY ACETABULAR COMPONENT	Howmedica Corp.	1998-10-02	63	0
K982602	RETROGRADE ROD SYSTEM	Howmedica Corp.	1998-09-14	49	0
K982494	BWM SPINE SYSTEM	Howmedica Corp.	1998-09-08	53	0
K982068	HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM	Howmedica Corp.	1998-08-31	80	0
K972401	HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIM	Howmedica Corp.	1998-07-13	382	0
K981261	HOWMEDICA SCN NAIL	Howmedica Corp.	1998-06-22	76	0
K974843	DURACON(R) SMALL STABILIZER TIBIAL INSERT	Howmedica Corp.	1998-06-18	176	0
K981201	OSTEOLOCK ACETABULAR CUP	Howmedica Corp.	1998-05-29	57	0
K980713	FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM	Howmedica Corp.	1998-05-22	87	0
K980364	HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS	Howmedica Corp.	1998-04-29	90	0
K971206	MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PE	Howmedica Corp.	1998-02-11	336	1
K973163	ACETABULAR SHELLS WITH MESH INGROWTH SURFACE	Howmedica Corp.	1997-11-21	88	0
K973164	HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS	Howmedica Corp.	1997-11-20	87	1
K973121	INTERAX TOTAL KNEE SYSTEM	Howmedica Corp.	1997-11-18	90	8
K972893	PARTNERSHIP REVISION FEMORAL STEMS	Howmedica Corp.	1997-11-03	90	0
K972864	DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS	Howmedica Corp.	1997-10-29	86	0
K972863	DURATION STABILIZED UHMWPE KNEE COMPONENTS	Howmedica Corp.	1997-10-29	86	4
K972551	ARTISAN PULSE LAVAGE SYSTEM	Howmedica Corp.	1997-10-29	113	0
K963502	CSCO FOREHEAD FIXATION SYSTEM	Howmedica Corp.	1997-10-28	420	0
K972752	DURACON CONVERSION METAL BACKED PATELLA	Howmedica Corp.	1997-10-21	90	0
K972792	DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS	Howmedica Corp.	1997-10-16	80	0
K972813	GAMMA LOCKING NAIL SYSTEM	Howmedica Corp.	1997-10-09	72	0
K972811	HOWMEDICA FULLY THREADED SCREWS	Howmedica Corp.	1997-10-06	70	0
K972479	ALTA PLATING SYSTEM	Howmedica Corp.	1997-09-11	72	0
K972108	ALTA INTRAMEDULLARY ROD SYSTEM	Howmedica Corp.	1997-08-12	68	0
K971854	OSTEOLOCK ACETABULAR SHELL SYSTEM	Howmedica Corp.	1997-07-30	71	0
K971755	HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM	Howmedica Corp.	1997-07-17	66	1
K971741	DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABL	Howmedica Corp.	1997-07-16	65	0
K971550	KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS	Howmedica Corp.	1997-07-08	71	0
K965173	DURATION STABILIZED UHMWPE KNEE COMPONENTS	Howmedica Corp.	1997-06-11	169	0
K963612	DURATION STABILIZED UHMWPE	Howmedica Corp.	1997-06-11	274	0
K970758	DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE	Howmedica Corp.	1997-05-22	80	0
K970200	RELIANCE PF FEMORAL STEMS	Howmedica Corp.	1997-04-09	78	1
K965175	HOWMEDICA MAINSTAY ANCHOR	Howmedica Corp.	1997-03-13	79	0
K965164	HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR	Howmedica Corp.	1997-03-13	79	0
K964951	KINEMAX PLUS TIBIAL SPACERS	Howmedica Corp.	1997-02-24	76	0
K964655	UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE	Howmedica Corp.	1997-02-06	78	0
K963796	KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORA	Howmedica Corp.	1996-12-09	77	0
K963242	DURACON POSTERIOR FEMORAL SPACER	Howmedica Corp.	1996-11-14	87	0
K963614	MONOTUBE CARBON TUBE	Howmedica Corp.	1996-11-06	57	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