Cleared Traditional

K935481 - SPONGER CABLE SYSTEM, MODIFICATION

K935481 is an FDA 510(k) clearance for SPONGER CABLE SYSTEM, manufactured by Pioneer Surgical Technology. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K935481 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
125d
Days
Class 2
Risk

K935481 is an FDA 510(k) clearance for the SPONGER CABLE SYSTEM, MODIFICATION. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 125 days - within the typical 510(k) review window.

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 Pioneer Surgical Technology devices

FDA 510(k) Submission Details - K935481

510(k) Number K935481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1993
Decision Date January 26, 1994
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 110
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K935481.
CONTROL CABLE SYSTEM
K934557 · Depuy, Inc. · Feb 1994
DALL MILES SYSTEM MINICLEAT
K934058 · Howmedica Corp. · Feb 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246 · Acu Med, Inc. · Feb 1994
ORTHOPAEDIC POLYETHYLENE CABLE
K924141 · Smith & Nephew Richards, Inc. · Nov 1993
OTI ORTHOPEDIC WIRE SYSTEM
K925447 · Osteo Technology, Inc. · Jun 1993
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
K923869 · Codman & Shurtleff, Inc. · May 1993