Cleared Traditional

SPONGER CABLE SYSTEM, MODIFICATION (K935481) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 50
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K935481.
DALL MILES SYSTEM GROOVED BUTTON
K934059 · Howmedica Corp. · Aug 1994
CONTROL CABLE SYSTEM
K934557 · Depuy, Inc. · Feb 1994
DALL MILES SYSTEM MINICLEAT
K934058 · Howmedica Corp. · Feb 1994
DEPUY (NITINO) GUIDE WIRE
K914693 · Depuy, Inc. · Dec 1991
MENNEN BONE FIXATION DEVICE
K892411 · Dentsply Intl. · Jan 1990
BONE FIXATION WIRE
K882967 · Baxter Healthcare Corp · Sep 1988