Cleared Traditional

K875156 - STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM

K875156 is an FDA 510(k) clearance for STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K875156 · Richards Medical Co., Inc. · Orthopedic device
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Jan 1988
Decision
36d
Days
Class 2
Risk

K875156 is an FDA 510(k) clearance for the STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on January 20, 1988 after a review of 36 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K875156

510(k) Number K875156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date January 20, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 122d · This submission: 36d
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 91
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K875156.
STERNOTOMY CABLE, SONGER CABLE SYSTEM
K903676 · Danek Medical, Inc. · Sep 1990
MENNEN BONE FIXATION DEVICE
K892411 · Dentsply Intl. · Jan 1990
BONE FIXATION WIRE
K882967 · Baxter Healthcare Corp · Sep 1988
ORTHOMET WIRE FOR SUTURE, CERCLAGE
K874919 · Orthomet, Inc. · Jan 1988
KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES
K850631 · Kirschner Medical Corp. · May 1985
ORTHOPAEDIC CABLE SYSTEM
K842977 · Richards Medical Co., Inc. · Oct 1984