Cleared Traditional

K944883 - GAMMA LOCKING NAIL - LONG LENGTH

K944883 is the FDA 510(k) clearance for GAMMA LOCKING NAIL - LONG LENGTH by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K944883 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
56d
Days
Class 2
Risk

K944883 is an FDA 510(k) clearance for the GAMMA LOCKING NAIL - LONG LENGTH. 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 November 28, 1994 after a review of 56 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 K944883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date November 28, 1994
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K944883.
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156 · Depuy, Inc. · May 1995
PEDIATRIC OSTEOTOMY SYSTEM
K945233 · Howmedica Corp. · Feb 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
K930836 · Howmedica Corp. · Jan 1995
GAMMA LOCKING NAIL MODIFICATION
K940286 · Howmedica, Inc. · Mar 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
K925460 · Synthes (Usa) · Mar 1994
GAMMA LOCKING NAIL-CROSS LOCKING SCREWS
K932174 · Howmedica Corp. · Mar 1994