Cleared Traditional

K994232 - PHALANGEAL FIXATION SYSTEM

K994232 is an FDA 510(k) clearance for PHALANGEAL FIXATION SYSTEM, manufactured by Medcanica, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K994232 · Medcanica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
76d
Days
Class 2
Risk

K994232 is an FDA 510(k) clearance for the PHALANGEAL FIXATION SYSTEM. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Medcanica, Inc. (Miami, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medcanica, Inc. devices

FDA 510(k) Submission Details - K994232

510(k) Number K994232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 124
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K994232.
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · Synthes (Usa) · Apr 2001
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
K003659 · Bionx Implants, Inc. · Feb 2001
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971 · Arthrex, Inc. · Aug 2000
METACARPAL FIXATION SYSTEM
K991064 · Medcanica, Inc. · Jun 1999
LACTOSORB BONE PIN
K990291 · Biomet, Inc. · Mar 1999
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
K983121 · Syntec Scientific Corp. · Oct 1998