Cleared Traditional

K953644 - VOLAR DISTAL RADIUS PLATE

K953644 is the FDA 510(k) clearance for VOLAR DISTAL RADIUS PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K953644 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
217d
Days
Class 2
Risk

K953644 is an FDA 510(k) clearance for the VOLAR DISTAL RADIUS PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 8, 1996 after a review of 217 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

Submission Details

510(k) Number K953644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date March 08, 1996
Days to Decision 217 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
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K953644.
PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K961497 · Howmedica, Inc. · Jun 1996
FOREFOOT RECONSTRUCTION SYSTEM
K961485 · Howmedica Corp. · Jun 1996
SCHUHLI IMPLANT SYSTEM
K954963 · Synthes (Usa) · Mar 1996
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · Zimmer, Inc. · Nov 1995
LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW
K951415 · Howmedica Corp. · Jun 1995
LUHR TITANIUM ALLOY PAN FIXATION SYSTEM
K945137 · Howmedica Corp. · Jun 1995