Cleared Traditional

K870727 - WARSAW ORTHOPEDIC I BONE PLATE

K870727 is an FDA 510(k) clearance for WARSAW ORTHOPEDIC I BONE PLATE, manufactured by Warsaw Orthopedic, Inc.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K870727 · Warsaw Orthopedic, Inc. · Orthopedic device
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Mar 1987
Decision
13d
Days
Class 2
Risk

K870727 is an FDA 510(k) clearance for the WARSAW ORTHOPEDIC I BONE PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 9, 1987 after a review of 13 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 Warsaw Orthopedic, Inc. devices

FDA 510(k) Submission Details - K870727

510(k) Number K870727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1987
Decision Date March 09, 1987
Days to Decision 13 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
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 27
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K870727.
TORUS EXTERNAL FIXATION SYSTEM
K925635 · Zimmer, Inc. · Jun 1993
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
ORTHOPEDIC FIXATION DEVICES
K821566 · Howmedica Corp. · Jun 1982
SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES
K792291 · Synthes (Usa) · Dec 1979