UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION— 510(k) K111444

Name: FDA 510(k) clearance K111444
Creator: U.S. Food and Drug Administration
Published: 2011-06-22

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K111444 for UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION, Substantially Equivalent on 2011-06-22. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Product code HSB
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2011-05-24
Decision date: 2011-06-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSB

view all

K261189 — Freedom Nail Ankle Fusion System2026-10-19
K261345 — Pediatric Nailing Platform Femur2026-09-24
K261481 — Pangea Femur Reconstruction System2026-06-29
K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)2026-06-18
K261651 — Precice Max System and Precice Ankle Salvage System2026-06-18

More clearances from DePuy Orthopaedics, Inc.

view all

K262130 — ATTUNE Revision Knee System2026-09-04
K252887 — DePuy ATTUNE Knee System2026-05-22
K231503 — CUPTIMIZE Advanced2023-08-22
K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
K210167 — DELTA XTEND Reverse Shoulder System2021-02-19

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, 2020-01-01 through 2026-04-23. 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.