Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zimmer Biomet and its 60 subsidiaries with 2,240 510(k) clearances, 2,225 device recalls, 1 warning letter and 1 AI-enabled device. The most recent is a 510(k) clearance dated Oct 7, 2026: APEX 3D S Diamond Tibia.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Zimmer Biomet and its 60 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 7, 2026 | APEX 3D S Diamond TibiaK261120 · HSN | 510(k) clearances |
| Sep 24, 2026 | OsseoFit Stemless Shoulder SystemK262955 · PKC | 510(k) clearances |
| Aug 28, 2026 | Primal K-Wire (P99-193-1410)K262722 · HTY | 510(k) clearances |
| Aug 24, 2026 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK253515 · JDI | 510(k) clearances |
| Aug 6, 2026 | Megalodon Dynamic Compression SystemK261121 · JDR | 510(k) clearances |
| Aug 3, 2026 | Grappler Suture Anchor SystemK262047 · MBI | 510(k) clearances |
| Jul 16, 2026 | Cable-Ready® Cable Grip SystemK261271 · JDQ | 510(k) clearances |
| Jul 1, 2026 | OSSTM Orthopedic Salvage SystemK253434 · JDI | 510(k) clearances |
| Feb 4, 2026 | Signature ONE SystemK260104 · Orthopedic | AI-enabled devices |
| Aug 2, 2019 | Warning letter: Medical DevicesCDRH | Warning letters |
| Nov 4, 2013 | LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The TimbeClass II · Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
