Cleared Traditional

K012655 - CONGRUENT BONE PLATE SYSTEM

K012655 is the FDA 510(k) clearance for CONGRUENT BONE PLATE SYSTEM by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K012655 · Acu Med, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
86d
Days
Class 2
Risk

K012655 is an FDA 510(k) clearance for the CONGRUENT BONE PLATE SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 86 days - a notably fast clearance 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: 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 Acu Med, Inc. devices

Submission Details

510(k) Number K012655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date November 07, 2001
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 900
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K012655.
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · Synthes (Usa) · Jan 2002
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · Biomet, Inc. · Dec 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · Synthes (Usa) · Dec 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · Synthes (Usa) · Sep 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · Howmedica Osteonics Corp. · Aug 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978 · Synthes (Usa) · Aug 2001