Medical device manufacturer
Biomet, Inc.
Biomet, Inc. holds 445 FDA 510(k) clearances across 89 product codes. Median elapsed review time is 85 days. openFDA lists 547 recall records naming the company. FDA publishes it under 9 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 445
- Product codes
- 89
- Median review
- 85 days
- Recall records
- 547
How does FDA spell Biomet, Inc.?
FDA publishes this company under 9 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, INC. | device/registrationlisting | normalised |
| Biomet | device/510k | normalised |
| Biomet | device/recall | normalised |
| Biomet | device/enforcement | normalised |
| Biomet Corporation | device/510k | normalised |
| Biomet Inc | device/recall | normalised |
| Biomet, Inc. | device/510k | normalised |
| Biomet, Inc. | device/enforcement | normalised |
Showing 8 of 9.
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, Inc. file in?
89 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 51 | 77 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 44 | 81 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 40 | 78 days | |
| HWC | Screw, Fixation, Bone | 24 | 85 days | |
| HRS | Plate, Fixation, Bone | 21 | 63 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 21 | 117 days | |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 11 | 137 days | |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 11 | 90 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 10 | 28 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 10 | 88 days | |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 9 | 71 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 8 | 58 days | |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 7 | 87 days | |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 7 | 146 days | |
| LOD | Bone Cement | 7 | 96 days | |
| MBB | Bone Cement, Antibiotic | 7 | 135 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 7 | 141 days | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 6 | 68 days | |
| HTY | Pin, Fixation, Smooth | 5 | 53 days | |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 5 | 88 days | |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 5 | 100 days | |
| FMF | Syringe, Piston | 4 | 90 days | |
| GXP | Methyl Methacrylate For Cranioplasty | 4 | 134 days | |
| HRX | Arthroscope | 4 | 130 days | |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 4 | 75 days |
Showing the 25 they file in most, of 89.
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, Inc. had a recall?
openFDA lists 547 recall records naming this company across its whole history, of which 7 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2867-2026Open, ClassifiedLXH
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2868-2026Open, ClassifiedLXH
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2869-2026Open, ClassifiedLXH
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2870-2026Open, ClassifiedLXH
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Z-2871-2026Open, ClassifiedLXH
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Showing the 5 most recently initiated of 547.
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, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253434 | OSSTM Orthopedic Salvage System | JDI | 273 | |
| K251270 | Taperloc® Complete Hip Stem | LPH | 390 | |
| K241014 | Biomet Kirschner Wires (K-Wires) | HTY | 40 | |
| K222760 | StageOne Select Hip Cement Spacer Molds | MBB | 106 | |
| K221968 | StageOne Shoulder Cement Spacer Molds | MBB | 72 | |
| K213287 | StageOne Knee Cement Spacer Molds | MBB | 336 | |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | JDG | 187 | |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | KWS | 128 | |
| K210192 | A.L.P.S. Clavicle Plating System | HRS | 25 | |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | MBI | 355 |
Source: openFDA device/510k · retrieved
Where is Biomet, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Biomet, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.