Cleared Traditional

K925635 - TORUS EXTERNAL FIXATION SYSTEM

K925635 is an FDA 510(k) clearance for TORUS EXTERNAL FIXATION SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K925635 · Zimmer, Inc. · Orthopedic device
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Jun 1993
Decision
204d
Days
Class 2
Risk

K925635 is an FDA 510(k) clearance for the TORUS EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 204 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K925635

510(k) Number K925635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date June 01, 1993
Days to Decision 204 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTW Device Classification - Class 2, Special Controls

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 22
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K925635.
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K982390 · Wrightmedicaltechnologyinc · Sep 1998
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · Synthes (Usa) · Nov 1995
MALLEOLAR SCREW
K931686 · Onyx Medical Corp. · Apr 1994
ANGLED BLADE PLATE
K914546 · Synthes (Usa) · Nov 1991
LEVTECH SMALL BONE PLATE
K893928 · Buckman Co., Inc. · Nov 1989
ACROMED ADS BONE NAIL
K862552 · Buckman Co., Inc. · Sep 1986