Cleared Traditional

K143716 - DSM Biomedical DPR Cable

K143716 is an FDA 510(k) clearance for DSM Biomedical DPR Cable, manufactured by Dsm Biomedical. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K143716 · Dsm Biomedical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
304d
Days
Class 2
Risk

K143716 is an FDA 510(k) clearance for the DSM Biomedical DPR Cable. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Dsm Biomedical (Exton, US). The FDA issued a Cleared decision on October 29, 2015 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dsm Biomedical devices

FDA 510(k) Submission Details - K143716

510(k) Number K143716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date October 29, 2015
Days to Decision 304 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
182d slower than avg
Panel avg: 122d · This submission: 304d
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 94
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K143716.
Arthrex FiberTape Cerclage
K170206 · Arthrex, Inc. · Nov 2017
KLS Martin LSS Plating System
K151983 · KLS-Martin L.P. · Apr 2016
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
K151848 · Zimmer, Inc. · Jan 2016
Suture Wires and Wire Loops
K150889 · Zimmer, Inc. · Jul 2015
PERI-PROSTHETIC CABLE SYSTEM
K133354 · Biomet, Inc. · Jan 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785 · Pioneer Surgical Technology, Inc. · Jan 2014