DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS— 510(k) K033329

Name: FDA 510(k) clearance K033329
Creator: U.S. Food and Drug Administration
Published: 2003-11-14

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K033329 for DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS, Substantially Equivalent on 2003-11-14. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Product code HSB
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2003-10-16
Decision date: 2003-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
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, Inc.

view all

K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS2005-03-14
K042664 — LPS UPPER EXTREMITY2004-12-08
K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY2004-07-22
K033959 — LPS2004-07-01
K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -0622004-05-28

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.