Cleared Traditional

DSM Biomedical DPR Cable (K143716) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 56
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K143716.
Thorecon™ Fixation System
K173579 · A & E Medical Corporation · Feb 2018
Arthrex FiberTape Cerclage
K170206 · Arthrex, Inc. · Nov 2017
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
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa) · Jul 2011