Cleared Traditional

K821566 - ORTHOPEDIC FIXATION DEVICES

K821566 is an FDA 510(k) clearance for ORTHOPEDIC FIXATION DEVICES, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K821566 · Howmedica Corp. · Orthopedic device
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Jun 1982
Decision
9d
Days
Class 2
Risk

K821566 is an FDA 510(k) clearance for the ORTHOPEDIC FIXATION DEVICES. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982 after a review of 9 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K821566

510(k) Number K821566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1982
Decision Date June 03, 1982
Days to Decision 9 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
113d faster than avg
Panel avg: 122d · This submission: 9d
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 30
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K821566.
LEVTECH SMALL BONE PLATE
K893928 · Buckman Co., Inc. · Nov 1989
WARSAW ORTHOPEDIC I BONE PLATE
K870727 · Warsaw Orthopedic, Inc. · Mar 1987
ACROMED ADS BONE NAIL
K862552 · Buckman Co., Inc. · Sep 1986
SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES
K792291 · Synthes (Usa) · Dec 1979
COMPRESSION HIP SCREW SYSTEM
K781762 · Howmedica Corp. · Dec 1978