Cleared Traditional

K932352 - ORTHOPEDIC BONE PLATE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932352 · Osteomed Corp. · Orthopedic device
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Jul 1995
Decision
782d
Days
Class 2
Risk

K932352 is an FDA 510(k) clearance for the ORTHOPEDIC 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 Osteomed Corp. (Fort Wayne, US). The FDA issued a Cleared decision on July 5, 1995 after a review of 782 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Osteomed Corp. devices

Submission Details

510(k) Number K932352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1993
Decision Date July 05, 1995
Days to Decision 782 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
660d slower than avg
Panel avg: 122d · This submission: 782d
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 1306
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