Cleared Traditional

K931244 - BONE PLATE

K931244 is the FDA 510(k) clearance for BONE PLATE by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K931244 · Acu Med, Inc. · Orthopedic device
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Feb 1994
Decision
341d
Days
Class 2
Risk

K931244 is an FDA 510(k) clearance for the BONE 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 Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Acu Med, Inc. devices

Submission Details

510(k) Number K931244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1993
Decision Date February 15, 1994
Days to Decision 341 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 122d · This submission: 341d
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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K931244.
1/3 TUBULAR PLATE
K931693 · Onyx Medical Corp. · Apr 1994
1/4 TUBULAR PLATE
K931694 · Onyx Medical Corp. · Apr 1994
LUHR MINI BONE SCREW AND Z PLATE
K935448 · Howmedica Corp. · Feb 1994
LUHR PAN FIXATION SYSTEM
K923861 · Howmedica Corp. · Mar 1993
ANSPACH MINI-PLATING SYSTEM
K921338 · The Anspach Effort, Inc. · Feb 1993
DALL MILES BROAD BONE PLATE
K922525 · Howmedica Corp. · Sep 1992