BIOMET, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1825034	1825034	BIOMET, INC.	1	Y	2026-01-01	56 E Bell Dr Po Box 587 WARSAW IN US 46581

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
3946	1366094108	P010014	OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM	NRA	2004-04-21
3946	1241100863	K994326	ASCENT KNEE SYSTEM	KWH	2000-01-07
3946	1650632723	K994184	PLR SPLINED REVISION STEM	LZO	2000-02-15
3946	1577585115	K994038	MODULAR REACH HIP	LPH	1999-12-22
3946	2045415813	K993956	TITANIUM PEDIATRIC FEMORAL NAIL	HSB	1999-12-20
3946	1626436159	K993886	EBI XFIX VISION FIXATION SYSTEM	KTT	1999-12-14
3946	1562905539	K993649	EBI XFIX DFS WRISTFIX SYSTEM	KTT	1999-11-19
3946	2013354644	K993510	MODIFIED BMP TROCHANTERIC PLATES	HRS	1999-11-16
3946	1795944773	K993465	DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE	HRS	2000-01-11
3946	1110631126	K993159	MAXIM KNEE SYSTEM	JWH	1999-10-14
3946	1632752208	K993111	ASCENT KNEE SYSTEM	JWH	1999-10-05
3946	1233707316	K992899	BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS	KWS	1999-10-21
3946	1922983824	K992515	EBI XFIX DFS OPTIROM ELBOW FIXATOR	KTT	1999-08-17
3946	1654689651	K992367	EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS	HWC	1999-09-23
3946	1596278752	K992355	LACTOSORB TRAUMA PLATING SYSTEM	HRS	1999-12-20
3946	2024954188	K992301	REUNITE SCREWS	HWC	1999-09-01
3946	1544138925	K992158	LACTOSORB SHEETS	JEY	1999-08-20
3946	1068456792	K992119	BIO-MODULAR SHOULDER SYSTEM	KWS	1999-09-13
3946	1821866250	K992058	BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM	JDI	1999-07-01
3946	1999719050	K991990	TRI-POLAR SYSTEM	KWY	1999-09-10
3946	1008928096	K991941	EBI XFIX DFS RAIL SYSTEM	KTT	1999-08-19
3946	1429924188	K991807	TITANIUM LOW PROFILE SCREWS	LPH	1999-07-08
3946	1091166684	K991806	VHS SUPRACONDYLAR PLATE SYSTEM	KTT	1999-08-06
3946	1129819197	K991763	LACTOSORB HAND SYSTEM	HRS	1999-07-30
3946	1031188119	K991649	DEPUY ROCKWOOD CLAVICLE PIN	JDW	1999-07-14
3946	1801357935	K991428	ASCENT KNEE SYSTEM	JWH	1999-05-21
3946	1425224317	K991298	BONE MULCH SCREW SYSTEM	HWC	1999-05-14
3946	1168462544	K990830	MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS	LPH	2000-04-11
3946	1511531225	K990392	DEPUY ACE SPIDER PLATE	HRS	1999-03-23
3946	1515916051	K990291	LACTOSORB BONE PIN	HTY	1999-03-23
3946	1756435945	K990120	MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE	HSB	1999-02-01
3946	1838176444	K990032	MODULAR PROTUSIO CUP	JDI	1999-02-18
3946	1556062427	K984458	DEPUY ACE SPIDER PLATE	HRS	1998-12-31
3946	1800594641	K984408	130 MODIFIED INTEGRAL FEMORAL COMPONENT	LPH	1999-02-12
3946	1985899332	K984390	LACTOSORB PANELS AND FASTENERS	HRS	2000-08-07
3946	1944111078	K984296	LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT	LPH	1999-02-18
3946	1929114029	K984209	STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED	HWC	1999-02-03
3946	1908906200	K984054	AGC V2 REVISION KNEE SYSTEM	JWH	1999-07-30
3946	1740273925	K984028	THE NEW BIO-MOORE ENDO HEADS	KWL	1999-01-19
3946	1875928523	K983910	ARTHRO-SURGIMAT-1500	HRX	1998-11-25
3946	1399677586	K983853	DEPUY ACE TIMAX META PLATE	HRS	1998-12-22
3946	1596900666	K983710	150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH	JDI	1998-12-02
3946	2038164680	K983265	DEPUY ACE COMPOSITE LOCKING NUT	HTN	1998-10-26
3946	1668063198	K983035	CUSTOM FLANGED ACETABULAR COMPONENT	LPH	1998-11-23
3946	1847228255	K982953	TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES	HSB	1998-10-21
3946	1213336108	K982869	ASCENT SYSTEM	JWH	1998-09-22
3946	1308984742	K982545	BMP CABLE SYSTEM	JDQ	1998-10-19
3946	1104430674	K982497	ARTHROTEK INTERFERENCE SCREW	HWC	1998-10-16
3946	1162269099	K982367	REACH HIP COMPONENT	LPH	1998-08-24
3946	1437423604	K982095	LACTOSORB MENISCAL REPAIR DEVICE	MAI	1999-01-27
3946	1760728559	K981967	WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE	MBI	1998-07-17
3946	1293298888	K981798	LACTOSORB POP RIVET	JDR	1998-07-13
3946	1726188136	K981775	DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE	HRS	1998-07-29
3946	1070140916	K981483	EBI DFS JOINT FIXATOR, MODEL 02800	KTT	1998-07-08
3946	1981331789	K980927	LACTOSORB PANELS AND FASTENERS	JEY	1998-06-05
3946	1940597226	K980665	REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS	HRY	1998-05-20
3946	2005344499	K980428	BIOMET BIAXIAL TOTAL ELBOW	JDC	1998-05-05
3946	1357699056	K980370	BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR	KTT	1998-04-14
3946	1130470892	K974781	DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL	HSB	1998-03-10
3946	1374710472	K974558	SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM	JDI	1998-03-04
3946	2052631081	K973775	HARPOON SUTURE ANCHORS	MBI	1998-04-16
3946	1493802268	K972860	CURVTEK TSR SYSTEM	HSZ	1997-10-31
3946	1013120852	K972629	DEPUY AE TK2 HIP SCREW SYSTEM	KTT	1997-10-09
3946	1263397641	K972183	DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL	HSB	1997-08-26
3946	1640282774	K971996	MEDIVISION ARTHROSCOP	HRX	1997-07-31
3946	1289281681	K971938	REPICCI II UNICONDYLAR KNEE	HRY	1997-08-25
3946	1608362543	K971890	RECOVERY PROTRUSIO CAGE	JDI	1997-08-07
3946	1537768154	K971870	LACTOSORB TRAUMA PLATING SYSTEM	HRS	1997-08-19
3946	1076344651	K971824	REACH FEMORAL HIP COMPONENT	LPH	1997-12-04
3946	1444474741	K971069	TWIST-OFF (TM) SCREW	HWC	1997-07-09
3946	1485241148	K970503	DEPUY ACE TROCHANTERIC SIDE PLATE	HRS	1997-04-30
3946	1182374070	K970501	PEGGED ACETABULAR COMPONENT	LPH	1997-04-30
3946	1112933415	K970290	EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM	KTT	1997-04-01
3946	1488430654	K970202	DEPUY ACE AIM TITANIUM TIBIAL NAIL	HSB	1997-03-21
3946	1523248117	K964970	BIOMET BONE SCREW	HWC	1997-04-03
3946	1298691986	K964880	VARI-ANGLE HIP SCREW (VHS) SYSTEM	KTT	1997-10-16
3946	1368889618	K964226	MEMORY STAPLE (20 SIZES AVAILABLE)	JDR	1997-08-05
3946	1270135109	K962236	SCARF THREAD-HEAD SCREW	HWC	1996-09-20
3946	1633115801	K962233	TWIST-OFF SCREW	HWC	1996-10-03
3946	1065175333	K961571	COCR BI-ANGULAR HUMERAL COMPONENT	KWT	1996-08-05
3946	1493224528	K961433	EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS	KTT	1996-06-28
3946	1008034565	K961260	KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY	HSD	1997-04-02
3946	1732525409	K960984	SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS	JDI	1996-09-17
3946	2023480787	K960856	KONSTRUCT PATELLAR COMPONENT	JWH	1996-11-27
3946	1224844134	K960642	NANCY NAIL	HTY	1996-05-17
3946	1718918488	K960363	BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143	MJT	1997-02-18
3946	1670635293	K960303	FENNING FEMORAL COMPONENT	LPH	1996-06-21
3946	1923715673	K955729	LACTOSORB TRAUMA PLATING SYSTEM	HRS	1996-02-14
3946	1922961573	K955472	ACE HUMERUS & RADIUS PLATES	HRS	1996-04-01
3946	1191450061	K955388	ACE-DUPONT COMPOSITE RINGS	LXT	1996-01-31
3946	1632835752	K954485	6.5MM SOLID CANCELLOUS BONE SCREW	HWC	1995-10-31
3946	1290384979	K954443	LACTOSORB SUTURE ANCHOR	JDR	1996-01-31
3946	1469014564	K954417	A-B ACETABULAR COMPONENT	LPH	1995-12-11
3946	2003591812	K953925	FINE GRAIN CAST COBALT CHROMIUM HIP STEMS	LZO	1996-01-31
3946	1017347057	K953406	EBI X FIX DYNAFIX SYSTEM (DFS)	KTT	1995-10-31
3946	1140989569	K951658	LACTOSORB POP RIVET	JDR	1995-07-25
3946	1398588779	K951357	EBI SMALL EXTERNAL FIXATOR (S/E/F/)	KTT	1995-06-21
3946	1111342730	K950761	INDEX ACETABULAT COMPONENT	JDI	1995-05-02
3946	1671529811	K950618	ACE SUPRACONDYLAR PLATE	HRS	1995-05-10
3946	1482386877	K945765	HIGH TEMPERATURE CAUTERY	GEI	1995-01-30
3946	1610880410	K945115	MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS	JDI	1995-05-02
3946	1719724035	K945028	FINN KNEE SYSTEM	KRO	1996-02-14
3946	1536842144	K943806	HARPOON SUTURE ANCHORS	HWC	1995-07-03
3946	1431384749	K943025	FREEMAN/SAMUELSON TOTAL KNEE SYSTEM	JWH	1996-03-13
3946	1027457171	K942479	INTEGRAL CO-CR FEMORAL COMPONENT	JDG	1994-09-20
3946	1150228095	K942028	RX90 FEMORAL COMPONENT	JDG	1994-09-19
3946	1975714019	K941941	BONE MULCH SCREW	HWC	1995-02-02
3946	1470498667	K941245	POLY-MEDICS HEAT PACK	IMD	1994-05-02
3946	1915335646	K936274	KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM	JWH	1995-01-18
3946	1856627268	K936045	ACE UNILATERAL FIXATOR II	JEC	1994-02-22
3946	1557110584	K934962	AIM SUPRACONDYLAR NAIL	HSB	1994-03-22
3946	1817011956	K934643	ACE HUMERAL NAIL	HSB	1994-03-22
3946	2043330963	K934469	ARTHROTEK INTERFERENCE SCREW	HWC	1994-02-23
3946	1914931733	K933968	ACE PELVIC STABILIZER	JEC	1994-06-16
3946	1020145955	K933070	ARTHTOTEK PRECISION HAND INSTRUMENTATION	HRX	1994-03-24
3946	1442738793	K932721	ARTHROTEK SET SCREW	HWC	1994-08-01
3946	1231429142	K931194	CO-CR ANSWER FEMORAL COMPONENT	JDG	1994-05-05
3946	1368827646	K931155	STAPLE, FIXATION BONE; SCREW FIXATION BONE	HWC	1994-09-01
3946	1282054039	K930592	ACE UNIVERSAL RECONSTRUCTION PLATE	HRS	1993-07-26
3946	2003029405	K926107	ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS	LPH	1993-07-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HRS	70	2025-07-25
KTT	54	2011-12-15
LPH	49	2026-09-23
HWC	48	2020-02-24
JDI	45	2026-08-24
JWH	43	2017-07-28
HSB	34	2018-12-14
MBI	27	2020-11-10
KWA	20	2011-09-30
PHX	17	2026-04-15
LZO	16	2020-12-08
KRO	16	2014-05-28
HTY	11	2024-05-22
MBF	11	2020-10-28
JDR	11	2015-10-02
HRY	11	2014-03-28
KWT	10	2023-07-12
MBH	10	2016-05-10
LXT	10	2013-10-09
MBB	7	2022-12-28
JDW	7	2011-02-17
JEC	7	1994-06-16
JDG	6	2022-02-07
KWS	6	2021-12-10
HRX	6	2008-01-14
HSD	6	2005-09-29
KWY	5	2008-10-31
MQV	4	2019-06-10
GAT	4	2017-02-17
KRR	4	2015-01-30
MEH	4	2002-05-31
LLZ	3	2023-07-25
JDS	3	2020-02-20
JDO	3	2018-02-07
JDC	3	2016-02-03
FMF	3	2014-08-27
HTN	3	2014-07-18
KXA	3	2007-06-29
KWI	3	2005-08-05
KWZ	3	2003-01-23

PMA#

C2A-TAPER ACETABULAR HIP SYSTEM
2011-02-11
Biomet, Inc.
C2A-TAPER ACETABULAR SYSTEM
2009-04-17
Biomet, Inc.
C2A TAPER ACETABULAR SYSTEM
2009-03-13
Biomet, Inc.
C2-A TAPER ACETABULAR SYSTEM
2007-11-30
Biomet, Inc.
C2A-TAPER ACETABULAR SYSTEM
2006-06-16
Biomet, Inc.
C2A-TAPER ACETABULAR SYSTEM
2006-02-01
Biomet, Inc.
C2 A-TAPER ACETABULAR SYSTEM
2005-12-16
Biomet, Inc.

PMN#

Biomet Kirschner Wires (K-Wires)
2024-05-22
Biomet, Inc.
StageOne? Select Hip Cement Spacer Molds
2022-12-28
Biomet, Inc.
StageOne™ Shoulder Cement Spacer Molds
2022-09-15
Biomet, Inc.
StageOne Knee Cement Spacer Molds
2022-09-02
Biomet, Inc.
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
2022-02-07
Biomet, Inc.
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
2020-11-10
Biomet, Inc.
THP Hip Fracture Plating System
2018-02-07
Biomet, Inc.
StageOne Disposable Cement Spacer Molds For Temporary Knee Prosthesis
2017-01-25
Biomet, Inc.
Persona Partial Knee System
2016-11-03
BIOMET, INC.
StageOne Select Cement Spacer Molds For Temporary Hip Replacement
2016-09-08
BIOMET, INC.
StageOne Disposable Cement Spacer Molds For Temporary Hemi-Shoulder Prosthesis
2016-06-16
Biomet, Inc.
Vanguard XP Knee System
2016-05-10
BIOMET, INC.
OSS/Arcos IM Total Femur Rod
2015-10-14
BIOMET, INC.
Arcos One-piece Femoral Revision System
2015-10-06
Biomet, Inc.
Refobacin Bone Cement R
2015-07-16
BIOMET, INC.
Affixus Tibial Nailing System
2015-06-10
BIOMET, INC.
G7 Dual Mobility System
2015-05-01
BIOMET, INC.
Echo Bi-Metric Microplasty Line Extension
2015-03-25
BIOMET, INC.
Vanguard 360 Revision Knee System
2015-02-12
Biomet, Inc.
G7 Freedom And Offset Liners, Freedom Head, Size 32
2015-02-10
Biomet, Inc.
Biomet Tibial Trays
2014-12-23
BIOMET, INC.
Echo Bi-Metric Microplasty Hip System
2014-12-18
BIOMET, INC.
G7 OSSEOTI ACETUBLAR SHELLS
2014-12-11
BIOMET, INC.
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
2014-10-27
BIOMET, INC.
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL
2014-10-27
BIOMET, INC.
Sirius Femoral Stem, Size 30A
2014-09-15
Biomet, Inc.
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
2014-08-27
BIOMET, INC.
BIOLOX DELTA CERAMIC OPTION HEADS
2014-08-18
BIOMET, INC.
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
2014-07-30
BIOMET, INC.
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
2014-07-03
BIOMET, INC.
BIOMET CANNULATED SCREW SYSTEM
2014-06-03
BIOMET, INC.
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
2014-05-13
BIOMET, INC.
ORTHOSORB LS
2014-04-18
BIOMET, INC.
TSP HIP FRACTURE PLATING SYSTEM
2014-04-04
BIOMET, INC.
PERI-PROSTHETIC CABLE SYSTEM
2014-01-27
BIOMET, INC.
VANGUARD XP KNEE SYSTEM
2013-12-11
BIOMET, INC.
2.5MM INLINE FUSION PLATE
2013-10-29
BIOMET, INC.
BIOLOX(R) DELTA CERAMIC HEADS
2013-10-10
BIOMET, INC.
SIRIUS FEMORAL STEM
2013-08-30
BIOMET, INC.
SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
2013-08-06
BIOMET, INC.

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