Company · US
Zimmer Biomet, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
875recalls (0 in 12 months)
645recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 295 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 93 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 85 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 59 |
| LXH | Orthopedic Manual Surgical Instrument | 51 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 49 |
| NKB | Thoracolumbosacral Pedicle Screw System | 25 |
| HRS | Plate, Fixation, Bone | 21 |
| HAW | Neurological Stereotaxic Instrument | 16 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 16 |
| HTY | Pin, Fixation, Smooth | 14 |
| HWC | Screw, Fixation, Bone | 14 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 13 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 |
| NJL | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | 11 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 6 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 6 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 6 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 6 |
| FZX | Guide, Surgical, Instrument | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2026 | K261453 | G7® Acetabular System Zimmer Biomet | LPH |
| Aug 15, 2025 | K251834 | Persona Partial Knee Zimmer Biomet | HSX |
| Jul 31, 2025 | K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners Zimmer Biomet | JDI |
| Jul 25, 2025 | K251620 | A.L.P.S. Proximal Humerus Plating System Zimmer Biomet | HRS |
| Apr 18, 2025 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) Zimmer Biomet | LZO |
| Dec 20, 2024 | K243293 | Zimmer® Persona® Personalized Knee System Zimmer Biomet | MBH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2020 | Zimmer Biomet, Inc. Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic Terminated |
HXZ | None listed |
| Nov 17, 2020 | Zimmer Biomet, Inc. Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system Terminated |
NKB | K140123 |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 61 mm
Number: 00-8065-958-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm
Number: 00-8065-956-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 57 mm
Number: 00-8065-954-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm
Number: 00-8065-952-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm
Number: 00-8065-950-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 51mm
Number: 00-8065-948-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 49 mm
Number: 00-8065-946-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm
Number: 00-8065-658-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm
Number: 00-8065-656-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm
Number: 00-8065-654-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm
Number: 00-8065-652-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm
Number: 00-8065-650-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm
Number: 00-8065-648-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm
Number: 00-8065-648-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm
Number: 00-8065-648-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm
Number: 00-8065-648-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm
Number: 00-8065-646-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm
Number: 00-8065-646-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm
Number: 00-8065-646-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm
Number: 00-8065-646-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm
Number: 00-8065-644-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm
Number: 00-8065-644-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm
Number: 00-8065-644-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm
Number: 00-8065-642-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm
Number: 00-8065-642-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm
Number: 00-8065-640-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm
Number: 00-8065-558-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 61 mm
Number: 00-8065-558-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm
Number: 00-8065-558-26 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm
Number: 00-8065-558-22 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 59 mm
Number: 00-8065-556-32 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm
Number: 00-8065-556-28 Terminated |
JDI | None listed |
| Sep 24, 2020 | Zimmer Biomet, Inc. ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm
Number: 00-8065-556-26 Terminated |
JDI | None listed |
Newest 50 of 875.