510(k) K241651 ยท HSB Rod, Fixation, Intramedullary And Accessories
Affixus Tibial and Antegrade Femoral Nailing System
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 26, 2024 |
| Received | Jun 7, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 m Open, Classified |
HSB | None listed |
| Dec 22, 2025 | Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.