Cleared Traditional

K963325 - SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL...

K963325 is the FDA 510(k) clearance for SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K963325 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
214d
Days
Class 2
Risk

K963325 is an FDA 510(k) clearance for the SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) 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 Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 25, 1997 after a review of 214 days - an extended review 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: 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 Synthes (Usa) devices

Submission Details

510(k) Number K963325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1996
Decision Date March 25, 1997
Days to Decision 214 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 slower than avg
Panel avg: 122d · This submission: 214d
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 932
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K963325.
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · Osteonics Corp. · 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
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
K961498 · Howmedica, Inc. · Feb 1997
KINAMED PROFIX SYSTEM
K964362 · Kinamed, Inc. · Jan 1997
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K962894 · Synthes (Usa) · Dec 1996