Cleared Traditional

K932174 - GAMMA LOCKING NAIL-CROSS LOCKING SCREWS

K932174 is the FDA 510(k) clearance for GAMMA LOCKING NAIL-CROSS LOCKING SCREWS by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K932174 · Howmedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
306d
Days
Class 2
Risk

K932174 is an FDA 510(k) clearance for the GAMMA LOCKING NAIL-CROSS LOCKING SCREWS. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Howmedica Corp. devices

Submission Details

510(k) Number K932174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1993
Decision Date March 07, 1994
Days to Decision 306 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
184d slower than avg
Panel avg: 122d · This submission: 306d
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 K932174.
GAMMA LOCKING NAIL - LONG LENGTH
K944883 · Howmedica Corp. · Nov 1994
GAMMA LOCKING NAIL MODIFICATION
K940286 · Howmedica, Inc. · Mar 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
K925460 · Synthes (Usa) · Mar 1994
CAP WASHER ASSEMBLY
K915599 · Howmedica Corp. · Oct 1993
ALTA CANCELLOUS BONE SCREW
K925127 · Howmedica Corp. · Mar 1993
MORREY ELBOW FIXATOR
K910993 · Howmedica Corp. · Nov 1992