Cleared Traditional

K955306 - OMEGA+ COMPRESSION SCREW SYSTEM

K955306 is an FDA 510(k) clearance for OMEGA+ COMPRESSION SCREW SYSTEM, 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 142-day FDA review.

K955306 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
142d
Days
Class 2
Risk

K955306 is an FDA 510(k) clearance for the OMEGA+ COMPRESSION SCREW SYSTEM. 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 April 10, 1996 after a review of 142 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K955306

510(k) Number K955306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date April 10, 1996
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 K955306.
SYNTHES MINI EXTERNAL FIXATOR
K961350 · Synthes (Usa) · Jun 1996
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
K961433 · Electro-Biology, Inc. · Jun 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
K961213 · Howmedica Corp. · Jun 1996
PRACTIFIX EXTERNAL FIXATION SYSTEM
K960014 · Orthopaedic Innovations, Inc. · Mar 1996
VERSA-FX FEMORAL FIXATION SYSTEM
K954555 · Zimmer, Inc. · Jan 1996
EBI X FIX DYNAFIX SYSTEM (DFS)
K953406 · Electro-Biology, Inc. · Oct 1995