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510(k) K253566

Affixus Retrograde Femoral Nailing System by Zimmer, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
November 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Zimmer, Inc.

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  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K250848 — Identity Shoulder System (July 2, 2025)
  • K243724 — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (March 6, 2025)
  • K243907 — Affixus Tibial Nailing System - 4mm screws (February 12, 2025)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (November 22, 2024)
  • K243247 — Persona the Personalized Knee System (October 29, 2024)

Other clearances for product code HSB

  • K253517 — Reselute Tibial Nail (March 10, 2026)
  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K252196 — Arthrex FibuLock Nail System (March 5, 2026)
  • K252025 — Active Intramedullary (AIM) Tibial Nail System (March 4, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253749 — Affixus® Natural Nail® Proximal Humeral System (December 12, 2025)
  • K252826 — ARIX Femur Nail System (December 10, 2025)
  • K250197 — Estremo Fibular Nail (October 17, 2025)
  • K250628 — DynaNail TTC Fusion System (September 12, 2025)
  • K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (August 20, 2025)