Cleared Traditional

K924018 - M3 LAG SCREW FIXATION SYSTEM

K924018 is the FDA 510(k) clearance for M3 LAG SCREW FIXATION SYSTEM by Osteomed Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K924018 · Osteomed Corp. · Orthopedic device
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Apr 1993
Decision
233d
Days
Class 2
Risk

K924018 is an FDA 510(k) clearance for the M3 LAG SCREW FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Osteomed Corp. (Glendale, US). The FDA issued a Cleared decision on April 1, 1993 after a review of 233 days - an extended review cycle.

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 Osteomed Corp. devices

Submission Details

510(k) Number K924018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date April 01, 1993
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 637
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K924018.
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
K921481 · Acufex Microsurgical, Inc. · Aug 1993
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579 · Techmedica, Inc. · Apr 1993
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · Arthrex, Inc. · Feb 1993
ACUFEX FIXATION POST
K924514 · Acufex Microsurgical, Inc. · Oct 1992