FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES— 510(k) K041081

Clearance details

Applicant

Hand Innovations, Inc.

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2004-04-26

Decision date

2004-07-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Miami, FL, US

• K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System2026-06-11
• K260900 — DYNEX® External Fixation Systems2026-04-17
• K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
• K253291 — Excelsior System2026-01-20
• K253202 — Hoffmann LRF System2025-12-19

• K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM2005-04-26
• K042059 — SHOULDER FIXATION SYSTEM2004-09-30
• K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEM2004-07-30
• K033406 — SMALL BONE FIXATION SYSTEM2004-01-15
• K032705 — DISTAL RADIUS FRACTURE REPAIR SYSTEM2003-10-01

Death

11

Injury

3,097

Malfunction

1,261

Total

4,369

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 →

• Z-2212-2014 — Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581Class II·Terminated·Biomet, Inc.·20140623

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041081.