Cleared Traditional

K934557 - CONTROL CABLE SYSTEM

K934557 is an FDA 510(k) clearance for CONTROL CABLE SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K934557 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
162d
Days
Class 2
Risk

K934557 is an FDA 510(k) clearance for the CONTROL CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 162 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K934557

510(k) Number K934557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1993
Decision Date February 25, 1994
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 111
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K934557.
SONGER CABLE SYSTEM
K941213 · Pioneer Surgical Technology · Apr 1994
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646 · Biodynamic Technologies, Inc. · Mar 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950 · Buckman Co., Inc. · Mar 1994
DALL MILES SYSTEM MINICLEAT
K934058 · Howmedica Corp. · Feb 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246 · Acu Med, Inc. · Feb 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481 · Pioneer Surgical Technology · Jan 1994