Cleared Traditional

K993465 - DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE

K993465 is an FDA 510(k) clearance for DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993465 · Depuy, Inc. · Orthopedic device
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Jan 2000
Decision
90d
Days
Class 2
Risk

K993465 is an FDA 510(k) clearance for the DEPUY ACE CALCANEAL PERI-ARTICULAR 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 Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 90 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K993465

510(k) Number K993465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1999
Decision Date January 11, 2000
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 1261
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K993465.
STRYKER TRAUMA PLATING SYSTEM
K000636 · Howmedica Osteonics Corp. · May 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066 · Synthes (Usa) · Mar 2000
LOCON-T DISTAL RADIAL PLATE
K994061 · Wrightmedicaltechnologyinc · Feb 2000
LACTOSORB TRAUMA PLATING SYSTEM
K992355 · Biomet, Inc. · Dec 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · Smith & Nephew, Inc. · Dec 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510 · Biomet, Inc. · Nov 1999