Cleared Traditional

K962894 - SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM

K962894 is the FDA 510(k) clearance for SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K962894 · Synthes (Usa) · Orthopedic device
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Dec 1996
Decision
145d
Days
Class 2
Risk

K962894 is an FDA 510(k) clearance for the SYNTHES 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 December 17, 1996 after a review of 145 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 Synthes (Usa) devices

Submission Details

510(k) Number K962894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1996
Decision Date December 17, 1996
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 K962894.
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325 · Synthes (Usa) · Mar 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 TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
K963798 · Synthes (Usa) · Nov 1996
SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
K962616 · Synthes (Usa) · Sep 1996
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
K961496 · Howmedica, Inc. · Jun 1996