Cleared Traditional

PHALANGEAL FIXATION SYSTEM

K994232 · Medcanica, Inc. · Orthopedic
Mar 2000
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K994232 is an FDA 510(k) clearance for the PHALANGEAL FIXATION SYSTEM, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Medcanica, Inc. (Miami, US). The FDA issued a Cleared decision on March 1, 2000, 76 days after receiving the submission on December 16, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K994232 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1999
Decision Date March 01, 2000
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

Similar Devices — HTY Pin, Fixation, Smooth

All 203
ZipToe? Hammertoe Fusion System
K253325 · Toetal Solutions · Dec 2025
Impact PEEK Union Nail System
K252657 · Nvision Biomedical Technologies, Inc. · Sep 2025
RONAVIS ? FX (FX-001)
K250315 · AIRS, Inc. · Aug 2025
PediFlex? Flexible Nail System
K251362 · OrthoPediatrics Corp. · Jun 2025
Impact PEEK Union Nail System
K250646 · Nvision Biomedical Technologies · Jun 2025
Biomet Kirschner Wires (K-Wires)
K241014 · Biomet, Inc. · May 2024