Cleared Traditional

K923477 - 3.5MM UNIVERSAL COMPRESSION SCREW

K923477 is an FDA 510(k) clearance for 3.5MM UNIVERSAL COMPRESSION SCREW, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K923477 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
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Mar 1993
Decision
274d
Days
Class 2
Risk

K923477 is an FDA 510(k) clearance for the 3.5MM UNIVERSAL COMPRESSION 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 March 19, 1993 after a review of 274 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K923477

510(k) Number K923477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date March 19, 1993
Days to Decision 274 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
152d slower than avg
Panel avg: 122d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K923477.
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579 · Techmedica, Inc. · Apr 1993
M3 LAG SCREW FIXATION SYSTEM
K924018 · Osteomed Corp. · Apr 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · Arthrex, Inc. · Feb 1993
ACUFEX FIXATION POST
K924514 · Acufex Microsurgical, Inc. · Oct 1992
ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
K923256 · Alphatec Mfg., Inc. · Oct 1992