Medical device manufacturer
Biomet Manufacturing, Inc.
Biomet Manufacturing, Inc. holds 128 FDA 510(k) clearances across 41 product codes. Median elapsed review time is 90 days. openFDA lists no recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 128
- Product codes
- 41
- Median review
- 90 days
- Recall records
- 0
How does FDA spell Biomet Manufacturing, Inc.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Biomet Manufacturing | device/510k | normalised |
| Biomet Manufacturing Corp | device/510k | normalised |
| Biomet Manufacturing, Inc. | device/510k | normalised |
| Biomet Manufacturing, LLC | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Biomet Manufacturing, Inc. file in?
41 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 15 | 138 days | |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 14 | 65 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 12 | 30 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 129 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 | 185 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 6 | 89 days | |
| HRS | Plate, Fixation, Bone | 5 | 168 days | |
| HWC | Screw, Fixation, Bone | 5 | 56 days | |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 | 68 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 4 | 73 days | |
| JDR | Staple, Fixation, Bone | 4 | 90 days | |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 4 | 87 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 60 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 219 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 29 days | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 56 days | |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 | 30 days | |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 2 | 29 days | |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 2 | 87 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 88 days | |
| LOD | Bone Cement | 2 | 106 days | |
| FTM | Mesh, Surgical | 1 | 294 days | |
| HAW | Neurological Stereotaxic Instrument | 1 | 63 days | |
| HTN | Washer, Bolt Nut | 1 | 67 days | |
| JDO | Device, Fixation, Proximal Femoral, Implant | 1 | 157 days |
Showing the 25 they file in most, of 41.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Biomet Manufacturing, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Biomet Manufacturing, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K230540 | Patient Specific Planning Solution 3D Bone Models | LLZ | 148 | |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | PHX | 449 | |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | PHX | 153 | |
| K202232 | Comprehensive Vault Reconstruction System | PHX | 196 | |
| K193038 | Comprehensive Shoulder System | MBF | 363 | |
| K182516 | Comprehensive Nano Stemless Shoulder | PKC | 221 | |
| K181611 | Comprehensive Reverse Shoulder System | PHX | 97 | |
| K173411 | Comprehensive Segmental Revision System (SRS) | PHX | 99 | |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | PHX | 138 | |
| K163651 | ExpressBraid Graft Manipulation | GAT | 56 |
Source: openFDA device/510k · retrieved
Watch what Biomet Manufacturing, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.