Cleared Traditional

CERCLAGE CABLE WITH HEX BUTTON (K974016) - FDA 510(k) Clearance

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

K974016 · Pioneer Surgical Technology · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 1997
Decision
58d
Days
Class 2
Risk

K974016 is an FDA 510(k) clearance for the CERCLAGE CABLE WITH HEX BUTTON. 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 December 19, 1997 after a review of 58 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 Pioneer Surgical Technology devices

Submission Details

510(k) Number K974016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1997
Decision Date December 19, 1997
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K974016.
SYNTHES CERCLAGE POSITIONING PIN
K992891 · Synthes (Usa) · Nov 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · Howmedica Osteonics Corp. · Feb 1999
BMP CABLE SYSTEM
K982545 · Biomet, Inc. · Oct 1998
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741 · Howmedica Corp. · Jul 1997
DALL-MILES TROCHANTER CABLE SUPERGRIP
K962162 · Howmedica Corp. · Aug 1996
SILKON STAINLESS STEEL CABLE SYSTEM
K962132 · Osteonics Corp. · Aug 1996