Chrysalis Intelligence · Sponsors · Biomet Manufacturing Corp

Biomet Manufacturing Corp

Warsaw, IN, US · 5 510(k) clearances · 20 PMAs

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Total clearances
5
2020-10-28 → 2023-07-25
Last 12 months
0
Product codes
3
Most recent
2023-07-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 3 2023-03-15
LLZ System, Image Processing, Radiological Class II Radiology 1 2023-07-25
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class II Orthopedic 1 2020-10-28
Class III

PMA approvals (20)

Total PMA records
20
Originals + supplements
Distinct product codes
1
First decision
2020-04-27
Most recent
2026-07-13
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-13 P010014-S117 Oxford™ Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2026-05-27 P010014-S112 Oxford Partial Knee System; Cementless Oxford™Partial Knee System Normal 180 Day Track NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2026-05-12 P010014-S116 Oxford® Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2026-04-20 P010014-S115 Oxford® Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2026-03-06 P010014-S114 Oxford Cementless Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2026-01-16 P010014-S113 Oxford Partial Knee System Special (Immediate Track) NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2025-08-07 P010014-S111 Oxford™ Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2025-08-07 P010014-S109 Oxford Partial Knee System Normal 180 Day Track NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2025-06-24 P010014-S110 OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2024-11-22 P010014-S107 Oxford® Partial Knee System Normal 180 Day Track No User Fee NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2024-11-22 P010014-S105 Oxford™ Cementless Partial Knee System Panel Track NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2024-11-18 P010014-S108 Oxford Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2024-08-19 P010014-S106 Oxford® Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2023-04-06 P010014-S104 Oxford Partial Knee 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2022-10-25 P010014-S103 Oxford® Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2022-07-14 P010014-S102 Oxford Partial Knee System Special (Immediate Track) NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2022-04-04 P010014-S101 Oxford Partial Knee System 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2021-12-17 P010014-S098 Oxford Partial Knee System Real-Time Process NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2020-12-07 P010014-S100 Oxford Partial Knee System Normal 180 Day Track No User Fee NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
2020-04-27 P010014-S097 The Oxford Partial Knee System 135 Review Track For 30-Day Notice NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2023-07-25 K230540 Patient Specific Planning Solution™ 3D Bone Models LLZ Class II Radiology
2023-03-15 K214001 Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System PHX Class II Orthopedic
2021-11-04 K211729 Comprehensive® Convertible Glenoid - Vivacit-E Liner PHX Class II Orthopedic
2021-02-19 K202232 Comprehensive Vault Reconstruction System PHX Class II Orthopedic
2020-10-28 K193038 Comprehensive Shoulder System MBF Class II Orthopedic
Data source: openFDA · Generated 2026-07-28 09:33 · Last ingest 2026-07-28T13:32:44.564635 · Pipeline: Chrysalis Intelligence