Cleared Traditional

K924142 - CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT

K924142 is an FDA 510(k) clearance for CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K924142 · Codman & Shurtleff, Inc. · Orthopedic device
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Jun 1993
Decision
302d
Days
Class 2
Risk

K924142 is an FDA 510(k) clearance for the CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Concord, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Elevated predicate reliance profile. 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K924142

510(k) Number K924142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1992
Decision Date June 15, 1993
Days to Decision 302 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
180d slower than avg
Panel avg: 122d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 353
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K924142.
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SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
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K922504 · Acromed Corp. · May 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
K922672 · Sofamor Danek Mfg., Inc. · May 1993