Cleared Traditional

K955472 - ACE HUMERUS & RADIUS PLATES

K955472 is an FDA 510(k) clearance for ACE HUMERUS & RADIUS PLATES, manufactured by Ace Medical Co.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K955472 · Ace Medical Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
123d
Days
Class 2
Risk

K955472 is an FDA 510(k) clearance for the ACE HUMERUS & RADIUS PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Ace Medical Co. (El Segundo, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 123 days - within the typical 510(k) review window.

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 Ace Medical Co. devices

FDA 510(k) Submission Details - K955472

510(k) Number K955472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1995
Decision Date April 01, 1996
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1042
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K955472.
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
K961496 · Howmedica, Inc. · Jun 1996
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
VOLAR DISTAL RADIUS PLATE
K953644 · Synthes (Usa) · Mar 1996
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · Zimmer, Inc. · Nov 1995