Stryker Orthopaedics
Stryker Orthopaedics holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2021, with 6 FDA device recalls on record.
Top product codes for Stryker Orthopaedics
FDA recalls by Stryker Orthopaedics
- Z-1915-2024 — Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
- Z-1911-2024 — Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
- Z-1912-2024 — Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
- Z-1914-2024 — Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
- Z-1913-2024 — Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
- Z-1910-2024 — Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stryker Orthopaedics
- K211703 — Insignia Hip Stem
- K191414 — EXETER Centralizer, EXETER 2.5mm Plug
- K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
- K173849 — Triathlon Total Knee System
- K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
- K153345 — Stryker Orthopaedics Hip Systems Labeling Update
- K151264 — Restoration Anatomic Shell
- K143085 — Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
- K143393 — Triathlon Tritanium Cone Augments
- K142462 — Restoration Anatomic Shell
- K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
- K132624 — TRIATHLON TRITANIUM METAL-BACKED PATELLA
- K072575 — TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
- K070170 — DALL-MILES SYSTEM
- K063816 — PCA ALUMINA FEMORAL HEADS
- K063822 — MODIFICATION TO HIPSTAR FEMORAL STEM
- K062553 — SIMPLEX P BONE CEMENT
- K051223 — HIPSTAR FEMORAL STEM
- K053514 — TRIATHLON TOTAL KNEE SYSTEM
- K053528 — SHORT CITATION FEMORAL STEM
- K052542 — ACCOLADE RPS HIP STEM
- K051741 — ACCOLADE HFX FEMORAL STEM
- K040432 — SOLAR 2 ANATOMIC SHOULDER
- K040412 — TRIDENT T ACETABULAR SHELLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.