Cleared Traditional

OSTEO BOS SYSTEM IN STAINLESS STEEL (K973204) - FDA 510(k) Clearance

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

K973204 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 1997
Decision
30d
Days
Class 2
Risk

K973204 is an FDA 510(k) clearance for the OSTEO BOS SYSTEM IN STAINLESS STEEL. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 30 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 Osteonics Corp. devices

Submission Details

510(k) Number K973204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1997
Decision Date September 25, 1997
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 695
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K973204.
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · Synthes (Usa) · Mar 1998
LACTOSORB PANELS
K974309 · Biomet, Inc. · Jan 1998
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438 · Osteonics Corp. · Dec 1997
ALTA PLATING SYSTEM
K972479 · Howmedica Corp. · Sep 1997
OSTEO BOS SYSTEM
K972323 · Osteonics Corp. · Sep 1997
OSTEO ANATOMICAL BONE PLATES
K972196 · Osteonics Corp. · Aug 1997