Cleared Traditional

OSS/(SCARF)- AND OSW-SCREW (K042079) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042079 · O.M.T. Oberflachen-Und Materialtechnologie GmbH · Orthopedic device
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Dec 2004
Decision
140d
Days
Class 2
Risk

K042079 is an FDA 510(k) clearance for the OSS/(SCARF)- AND OSW-SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by O.M.T. Oberflachen-Und Materialtechnologie GmbH (Huntington, US). The FDA issued a Cleared decision on December 20, 2004 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 O.M.T. Oberflachen-Und Materialtechnologie GmbH devices

Submission Details

510(k) Number K042079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date December 20, 2004
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K042079.
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583 · Wrightmedicaltechnologyinc · Jan 2005
MULTI-USE COMPRESSION SCREW
K043102 · Wrightmedicaltechnologyinc · Jan 2005
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
K043281 · Wrightmedicaltechnologyinc · Jan 2005
BIO-CORE INTERFERENCE SCREW
K042552 · Biomet, Inc. · Dec 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
K043337 · Arthrex, Inc. · Dec 2004
ARTHREX TRIMIT FAMILY
K041189 · Arthrex, Inc. · Nov 2004