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., part of Stryker CorporationLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Stryker Orthopaedics with 25 510(k) clearances and 6 device recalls. The most recent is a device recall dated Apr 15, 2024: Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthropl….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 Class II · Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed | Device recalls |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 Class II · Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed | Device recalls |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 Class II · Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed | Device recalls |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 Class II · Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed | Device recalls |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 Class II · Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed | Device recalls |
| Apr 15, 2024 | Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 Class II · Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed | Device recalls |
| Aug 16, 2021 | Insignia Hip StemK211703 · MEH | 510(k) clearances |
| Aug 28, 2019 | EXETER Centralizer, EXETER 2.5mm PlugK191414 · JDI | 510(k) clearances |
| Aug 22, 2019 | Triathlon Total Knee System-Additional ComponentsK190402 · JWH | 510(k) clearances |
| Mar 19, 2018 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsK173499 · JDG | 510(k) clearances |
| Feb 2, 2018 | Triathlon Total Knee SystemK173849 · MBH | 510(k) clearances |
| Oct 30, 2017 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemK172326 · JWH | 510(k) clearances |
| May 25, 2016 | Stryker Orthopaedics Hip Systems Labeling UpdateK153345 · LPH | 510(k) clearances |
| Aug 10, 2015 | Restoration Anatomic ShellK151264 · LPH | 510(k) clearances |
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
