Cleared Traditional

K823548 - COMPRESSION HIP SCREW SIDE-PLATE

K823548 is the FDA 510(k) clearance for COMPRESSION HIP SCREW SIDE-PLATE by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K823548 · Howmedica Corp. · Orthopedic device
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Dec 1982
Decision
28d
Days
Class 2
Risk

K823548 is an FDA 510(k) clearance for the COMPRESSION HIP SCREW SIDE-PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 28 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

Submission Details

510(k) Number K823548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1982
Decision Date December 28, 1982
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple 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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 271
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K823548.
T.O.D. PLATE SYS STERILE
K842695 · Kirschner Medical Corp. · Sep 1984
ACE/FISHER EXTERNAL FIXATOR
K842768 · Buckman Co., Inc. · Sep 1984
CORSTREN COMPRESSION TUBE & PLATE
K830196 · Zimmer, Inc. · Mar 1983
HUCKSTEP INTRAMEDULLARY NAIL
K811017 · Downs Surgical , Ltd. · May 1981
DYNAMIC HIP SCREW
K791619 · Synthes (Usa) · Aug 1979
PEDIATRIC OSTEOTOMY SYSTEM
K790501 · Howmedica Corp. · Apr 1979