Cleared Traditional

K971321 - OSTEO COMPRESSION CONDYLE SCREW SYSTEM

K971321 is an FDA 510(k) clearance for OSTEO COMPRESSION CONDYLE SCREW SYSTEM, manufactured by Osteonics Corp.. 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.

K971321 · Osteonics Corp. · Orthopedic device
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Jul 1997
Decision
90d
Days
Class 2
Risk

K971321 is an FDA 510(k) clearance for the OSTEO COMPRESSION CONDYLE SCREW 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 Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 9, 1997 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K971321

510(k) Number K971321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date July 09, 1997
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 1269
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K971321.
LACTOSORB TRAUMA PLATING SYSTEM
K971870 · Biomet, Inc. · Aug 1997
LORENZ PECTUS SUPPORT BAR
K972420 · Walter Lorenz Surgical, Inc. · Aug 1997
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
K961719 · Howmedica Leibinger, Inc. · Jul 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES
K970258 · Ferguson Medical · May 1997
CENTRE-DRIVE DRILL-FREE SCREW
K971297 · KLS-Martin L.P. · May 1997
DEPUY ACE TROCHANTERIC SIDE PLATE
K970503 · Depuy Ace Medical Co. · Apr 1997