Cleared Traditional

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional (K172975) - FDA 510(k) Clearance

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

K172975 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Orthopedic device
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Jun 2018
Decision
267d
Days
Class 2
Risk

K172975 is an FDA 510(k) clearance for the DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, De.... Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (West Chester, US). The FDA issued a Cleared decision on June 21, 2018 after a review of 267 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 Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K172975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date June 21, 2018
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 53
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K172975.
Thorecon Rigid Fixation System
K181607 · A & E Medical Corporation · Oct 2018
Impress SFS System
K173910 · Cable Fix Medical, LLC · Sep 2018
SuperCable® Iso-Elastic™ Cerclage System
K181749 · Kinamed, Incorporated · Aug 2018
Sternal Cable System
K180582 · A & E Medical Corporation · May 2018
Thorecon™ Fixation System
K173579 · A & E Medical Corporation · Feb 2018
Arthrex FiberTape Cerclage
K170206 · Arthrex, Inc. · Nov 2017