Cleared Traditional

K151848 - Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System

K151848 is an FDA 510(k) clearance for Cable-Ready Cable Grip System: Cable-Re..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K151848 · Zimmer, Inc. · Orthopedic device
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Jan 2016
Decision
192d
Days
Class 2
Risk

K151848 is an FDA 510(k) clearance for the Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle Sy.... Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 192 days - an extended review 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: 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K151848

510(k) Number K151848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2015
Decision Date January 15, 2016
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
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 109
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K151848.
Arthrex FiberTape Cerclage
K170206 · Arthrex, Inc. · Nov 2017
Tritium® Sternal Cable Plate System
K161876 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Sep 2016
KLS Martin LSS Plating System
K151983 · KLS-Martin L.P. · Apr 2016
Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
K153242 · Frontier Medical Devices, Inc. · Jan 2016
Frontier Medical Devices In-line Orthopedic Cable Cerclage System
K151888 · Frontier Medical Devices, Inc. · Oct 2015
DSM Biomedical DPR Cable
K143716 · Dsm Biomedical · Oct 2015