Cleared Traditional

K932174 - GAMMA LOCKING NAIL-CROSS LOCKING SCREWS

K932174 is an FDA 510(k) clearance for GAMMA LOCKING NAIL-CROSS LOCKING SCREWS, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K932174

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.

KTT Device Classification - Class 2, Special Controls

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 358
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K932174.
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
K926417 · Alphatec Mfg., Inc. · Sep 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