510(k) K193515 ยท OLO Orthopedic Stereotaxic Instrument
Mako Total Knee Application
| Applicant | Mako Surgical Corp., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Jul 14, 2020 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | Stryker Orthopaedics 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. Open, Classified |
OLO | None listed |
| May 28, 2024 | Stryker Orthopaedics 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 + Open, Classified |
OLO | None listed |
| May 28, 2024 | Stryker Orthopaedics 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. Open, Classified |
OLO | None listed |
| May 28, 2024 | Stryker Orthopaedics 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 Open, Classified |
OLO | None listed |
| May 28, 2024 | Stryker Orthopaedics 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. Open, Classified |
OLO | None listed |
| May 28, 2024 | Stryker Orthopaedics 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 + T Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.