Howmedica Corp.

Mchenry, IL, US

Howmedica Corp. appears in FDA device records in Mchenry, IL. FDA records list 409 510(k) clearances between 1976-08-26 and 1999-02-24, 20 PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 409
PMA records: 20
Recall records: 0
Registered establishments: 0

510(k) clearance history

Showing 50 of 409

FDA records hold 409 510(k) clearances for Howmedica Corp. between 1976 and 1999. The busiest year on record is 1995, with 46. The most recent is 1999, with 4.

Clearances by year, as a table

510(k) clearance decisions for Howmedica Corp., by decision year
Year	Clearances
1976	6
1977	16
1978	10
1979	24
1980	21
1981	20
1982	23
1983	10
1984	4
1985	13
1986	8
1987	10
1988	6
1989	15
1990	11
1991	14
1992	14
1993	10
1994	33
1995	46
1996	26
1997	34
1998	31
1999	4

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K984251	XIA SPINE SYSTEM	KWQ	Substantially Equivalent	1999-02-24
K984202	HOWMEDICA HUMERAL INTERCALARY SYSTEM	HSD	Substantially Equivalent	1999-02-05
K984305	ZETA MULTIZONE LOCKING NAIL SYSTEM	HSB	Substantially Equivalent	1999-02-01
K983885	BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES	JEY	Substantially Equivalent	1999-01-29
K983528	MICRO DYNAMIC MESH	JEY	Substantially Equivalent	1998-12-23
K983404	TYPE 3 FEMORAL COMPONENTS	LZO	Substantially Equivalent	1998-12-22
K980926	DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION	JDI	Substantially Equivalent	1998-12-16
K980925	DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION	JWH	Substantially Equivalent	1998-12-16
K980632	DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION	JWH	Substantially Equivalent	1998-12-11
K980626	DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION	JDI	Substantially Equivalent	1998-12-11
K983419	HOFFMANN II MIAMI POST	HRS	Substantially Equivalent	1998-11-25
K982958	ZETA MULTIZONE LOCKING NAIL SYSTEM	HSB	Substantially Equivalent	1998-11-20
K983358	G/K SFN AND STN LOCKING NAILS	HSB	Substantially Equivalent	1998-11-18
K982873	ZETA MULTIZONE SCN LOCKING NAIL	HSB	Substantially Equivalent	1998-10-21
K982531	HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM	HRS	Substantially Equivalent	1998-10-16
K982670	CONTEMPORARY ACETABULAR COMPONENT	JDI	Substantially Equivalent	1998-10-02
K982463	EXTRACRANIAL RADIOTHERAPY SYSTEM	IYE	Substantially Equivalent	1998-09-30
K982602	RETROGRADE ROD SYSTEM	HSB	Substantially Equivalent	1998-09-14
K982494	BWM SPINE SYSTEM	KWP	Substantially Equivalent	1998-09-08
K982248	HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A	LPH	Substantially Equivalent	1998-08-31
K982068	HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM	JDW	Substantially Equivalent	1998-08-31
K972401	HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS	KRO	Substantially Equivalent	1998-07-13
K980813	RELIANCE LONG STEM FEMORAL COMPONENTS	JDI	Substantially Equivalent	1998-06-26
K981261	HOWMEDICA SCN NAIL	HSB	Substantially Equivalent	1998-06-22
K974843	DURACON(R) SMALL STABILIZER TIBIAL INSERT	JWH	Substantially Equivalent for Some Indications	1998-06-18
K981283	ROGACHEFSKY DISTAL RADIUS PLATES	HRS	Substantially Equivalent	1998-06-10
K980843	EXETER INTRAMEDULLARY BONE PLUG	JDI	Substantially Equivalent	1998-06-02
K981201	OSTEOLOCK ACETABULAR CUP	LZO	Substantially Equivalent	1998-05-29
K980713	FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM	JWH	Substantially Equivalent	1998-05-22
K980364	HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS	HWC	Substantially Equivalent	1998-04-29
K980239	PARTNERSHIP CALCAR FEMORAL COMPONENTS	LZO	Substantially Equivalent	1998-04-16
K974720	HOWMEDICA(R) FULLY THREADED SCREWS	HSB	Substantially Equivalent	1998-03-13
K974289	EPI-UNION PLATING SYSTEM	HRS	Substantially Equivalent for Some Indications	1998-02-12
K971206	MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING	LPH	Substantially Equivalent for Some Indications	1998-02-11
K973982	ORBITAL RECONSTRUCTION PLATES	HRS	Substantially Equivalent	1998-01-12
K974054	DISTAL CENTRALIZER, EXETER II HIP SYSTEM	JDI	Substantially Equivalent	1997-12-23
K972228	MERIDIAN TITANIUM FEMORAL STEMS	LZO	Substantially Equivalent for Some Indications	1997-12-05
K973484	CHIN DISTRACTOR	JEY	Substantially Equivalent	1997-12-02
K973163	ACETABULAR SHELLS WITH MESH INGROWTH SURFACE	LPH	Substantially Equivalent	1997-11-21
K973321	HOFFMANN II COMPACT PERIARTICULAR CLAMP	KTT	Substantially Equivalent	1997-11-20
K973164	HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS	JWH	Substantially Equivalent for Some Indications	1997-11-20
K973121	INTERAX TOTAL KNEE SYSTEM	JWH	Substantially Equivalent	1997-11-18
K972928	KERBOULL CROSS	JDI	Substantially Equivalent for Some Indications	1997-11-03
K972893	PARTNERSHIP REVISION FEMORAL STEMS	LZO	Substantially Equivalent	1997-11-03
K972864	DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS	JWH	Substantially Equivalent	1997-10-29
K972863	DURATION STABILIZED UHMWPE KNEE COMPONENTS	JWH	Substantially Equivalent	1997-10-29
K972551	ARTISAN PULSE LAVAGE SYSTEM	FQH	Substantially Equivalent	1997-10-29
K963502	CSCO FOREHEAD FIXATION SYSTEM	MBI	Substantially Equivalent	1997-10-28
K972752	DURACON CONVERSION METAL BACKED PATELLA	JWH	Substantially Equivalent	1997-10-21
K972792	DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS	JDI	Substantially Equivalent	1997-10-16

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain