DeviceClearance

Affixus Retrograde Femoral Nailing System— 510(k) K253566

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K253566 for Affixus Retrograde Femoral Nailing System, Substantially Equivalent on 2026-03-12. Applicant: Zimmer, Inc.. Device class: 2.

Summary

Zimmer's Affixus Retrograde Femoral Nailing System is filed under HSB, intramedullary fixation rods and accessories. The record doesn't list nail lengths or diameters.

Class II, 21 CFR 888.3020. It was a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.

Zimmer filed from Warsaw, Indiana. The decision came 115 calendar days after FDA received it (November 17, 2025 to March 12, 2026).

Clearance details

Applicant
Zimmer, Inc.
Product code
Product code HSB
Device class
Class 2
Regulation
21 CFR 888.3020
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HSB

product code HSB
Death
49
Injury
12,083
Malfunction
6,561
Other
1
Total
18,694

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.