Cleared Traditional

K915124 - UNIVERSAL COMPRESION SCREW

K915124 is the FDA 510(k) clearance for UNIVERSAL COMPRESION SCREW by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K915124 · Howmedica Corp. · Orthopedic device
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Feb 1992
Decision
90d
Days
Class 2
Risk

K915124 is an FDA 510(k) clearance for the UNIVERSAL COMPRESION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 11, 1992 after a review of 90 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 Howmedica Corp. devices

Submission Details

510(k) Number K915124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date February 11, 1992
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K915124.
CONCEPT ENDOSTEAL FIXATION DEVICE
K912640 · Concept, Inc. · May 1992
CORTICAL BONE SCREW
K915448 · Dow Corning Wright · Feb 1992
BONE SCREW 3.5 MM
K915613 · Acu Med, Inc. · Feb 1992
M. KUROSAKA(TM) FIXATION SCREW
K913210 · Depuy, Inc. · Jan 1992
OREGON FIXATION SCREW
K910976 · Acu Med, Inc. · Jan 1992
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991