Stryker Orthopaedics
Mahwah, NJ, US
Stryker Orthopaedics appears in FDA device records in Mahwah, NJ. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Stryker Orthopaedics between 2004 and 2021. The busiest year on record is 2007, with 4. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 4 |
| 2008 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211703 | Insignia Hip Stem | MEH | Substantially Equivalent | |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | JDI | Substantially Equivalent | |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | JDG | Substantially Equivalent | |
| K173849 | Triathlon Total Knee System | MBH | Substantially Equivalent | |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | JWH | Substantially Equivalent | |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | Substantially Equivalent | |
| K151264 | Restoration Anatomic Shell | LPH | Substantially Equivalent | |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach | LPH | Substantially Equivalent | |
| K143393 | Triathlon Tritanium Cone Augments | MBH | Substantially Equivalent | |
| K142462 | Restoration Anatomic Shell | LPH | Substantially Equivalent | |
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS | MBH | Substantially Equivalent | |
| K132624 | TRIATHLON TRITANIUM METAL-BACKED PATELLA | MBH | Substantially Equivalent | |
| K072575 | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE | MBH | Substantially Equivalent | |
| K070170 | DALL-MILES SYSTEM | HRS | Substantially Equivalent | |
| K063816 | PCA ALUMINA FEMORAL HEADS | LZO | Substantially Equivalent | |
| K063822 | MODIFICATION TO HIPSTAR FEMORAL STEM | LPH | Substantially Equivalent | |
| K062553 | SIMPLEX P BONE CEMENT | LOD | Substantially Equivalent | |
| K051223 | HIPSTAR FEMORAL STEM | LZO | Substantially Equivalent | |
| K053514 | TRIATHLON TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K053528 | SHORT CITATION FEMORAL STEM | MEH | Substantially Equivalent | |
| K052542 | ACCOLADE RPS HIP STEM | LZO | Substantially Equivalent | |
| K051741 | ACCOLADE HFX FEMORAL STEM | LZO | Substantially Equivalent | |
| K040432 | SOLAR 2 ANATOMIC SHOULDER | HSD | Substantially Equivalent | |
| K040412 | TRIDENT T ACETABULAR SHELLS | LPH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LODBone Cement
- HRSPlate, Fixation, Bone
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment | Class II | Open, Classified | |
| 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 | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment | Class II | Open, Classified | |
| 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 | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment | Class II | Open, Classified | |
| 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 | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment | Class II | Open, Classified | |
| 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 | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment | Class II | Open, Classified | |
| 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 | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain