Cleared Traditional

K261271 - Cable-Ready Cable Grip System

K261271 is the FDA 510(k) clearance for Cable-Ready Cable Grip System by Pioneer Surgical Technology, Inc.. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K261271 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Jul 2026
Decision
90d
Days
Class 2
Risk

K261271 is an FDA 510(k) clearance for the Cable-Ready® Cable Grip System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on July 16, 2026 after a review of 90 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, Inc. devices

Submission Details

510(k) Number K261271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2026
Decision Date July 16, 2026
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 83
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K261271.
Stitch Cerclage – Suture Tapes
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Arthrex FiberTape and TigerTape Cerclage Sutures
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Mbrace Cable
K232733 · Medacta International S.A. · May 2024
ACCORD Cable System
K233949 · Smith & Nephew, Inc. · Mar 2024
VariTrax Sternal CircumFixation System
K232986 · Circumfix Solutions, Inc. · Jan 2024
Arthrex Radiopaque FiberTape Cerclage sutures
K230976 · Arthrex, Inc. · Aug 2023