Cleared Traditional

K924142 - CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT

K924142 is the FDA 510(k) clearance for CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT by Codman & Shurtleff, Inc.. It is a Class 2 Orthopedic device (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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Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 192
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K924142.
COTREL - DUBOUSSET SPINE IMPLANTS
K921056 · Buckman Co., Inc. · Jun 1993
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767 · Buckman Co., Inc. · Jun 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948 · Synthes (Usa) · Jun 1993
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K912837 · Kirschner Medical Corp. · Aug 1992
CROSSLINK SYSTEM
K911663 · Synthes (Usa) · Mar 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · Danek Medical, Inc. · Jan 1992