510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Biomet Manufacturing Corp

Warsaw, IN, US

Biomet Manufacturing Corp appears in FDA device records in Warsaw, IN. FDA records list 128 510(k) clearances between and , 106 PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
128
PMA records
106
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 128

FDA records hold 128 510(k) clearances for Biomet Manufacturing Corp between 1999 and 2023. The busiest year on record is 2006, with 19. The most recent is 2023, with 2.

Clearances by year, as a table
510(k) clearance decisions for Biomet Manufacturing Corp, by decision year
YearClearances
19992
20004
20014
20021
20047
20054
200619
200717
20087
20096
20104
20119
20127
20138
20148
20156
20165
20171
20183
20191
20201
20212
20232
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K230540Patient Specific Planning Solution™ 3D Bone ModelsLLZSubstantially Equivalent
K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemPHXSubstantially Equivalent
K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerPHXSubstantially Equivalent
K202232Comprehensive Vault Reconstruction SystemPHXSubstantially Equivalent
K193038Comprehensive Shoulder SystemMBFSubstantially Equivalent
K182516Comprehensive Nano Stemless ShoulderPKCSubstantially Equivalent
K181611Comprehensive Reverse Shoulder SystemPHXSubstantially Equivalent
K173411Comprehensive Segmental Revision System (SRS)PHXSubstantially Equivalent
K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini BaseplatePHXSubstantially Equivalent
K163651ExpressBraid Graft ManipulationGATSubstantially Equivalent
K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)PHXSubstantially Equivalent
K153558Ventix Suture AnchorMBISubstantially Equivalent
K152262Ventix Knotless AnchorsMBISubstantially Equivalent
K152868ExpressBraid Graft ManipulationGATSubstantially Equivalent
K153398Comprehensive SRS/Nexel ElbowJDCSubstantially Equivalent
K151615TiTHON Staple with OsseoTi TechnologyJDRSubstantially Equivalent
K150768JuggerKnot Soft AnchorsMBISubstantially Equivalent
K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialJDISubstantially Equivalent
K150424JuggerStitch Meniscal Repair DeviceMBISubstantially Equivalent
K143697Biomet Proximal Humerus Plating SystemHRSSubstantially Equivalent
K143037SnapShot Fixation SystemJDRSubstantially Equivalent
K1431883.Omm Biomet Cannulated Screw SystemHWCSubstantially Equivalent
K141263TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITSJDRSubstantially Equivalent
K142658Biomet Headless Compression and Twist-off ScrewsHWCSubstantially Equivalent
K140390TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESISMBFSubstantially Equivalent
K141219JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITSHTNSubstantially Equivalent
K140652POROUS COATED COMPREHENSIVE FRACTURE STEMSPHXSubstantially Equivalent
K140509BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLEKROSubstantially Equivalent
K131135BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESISMBBSubstantially Equivalent
K132898A.L.P.S. CALCANEAL PLATING SYSTEMHRSSubstantially Equivalent
K130390COMPREHENSIVE CONVERTIBLE GLENOIDPHXSubstantially Equivalent
K131353COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHEREPHXSubstantially Equivalent
K132239COMPREHENSIVE REVERSE SHOULDER SCREWSPHXSubstantially Equivalent
K123907PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,KRRSubstantially Equivalent
K130033TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TOMBISubstantially Equivalent
K122770BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831HRSSubstantially Equivalent
K122160VANGUARD XP KNEE SYSTEMMBHSubstantially Equivalent
K121874G7 ACETABULAR SYSTEMPBISubstantially Equivalent
K122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMHRYSubstantially Equivalent
K120030TAPERLOC COMPLETE SIZE 4MM AND XR 123LPHSubstantially Equivalent
K113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSKWASubstantially Equivalent
K121149VANGUARD SSK 360 REVISION KNEE SYSTEMJWHSubstantially Equivalent
K113550VANGUARD COMPLETE KNEE SYSTEMJWHSubstantially Equivalent
K113069COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAYPHXSubstantially Equivalent
K113121COMPREHENSIVE REVERSE SHOULDERPHXSubstantially Equivalent
K110400TAPERLOC COMPLETE MICROPLASTY STEMKWASubstantially Equivalent
K110271MAESTRO WRIST PLATING SYSTEMHRSSubstantially Equivalent
K110320COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEMHRSSubstantially Equivalent
K110555ARCOMXL ACTIVE ARTICULATIONLPHSubstantially Equivalent
K102580VANGUARD REMOVABLE MOLDED POLY TIBIAJWHSubstantially Equivalent

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 , FDA export datePage updated Source: openFDA, public domain