Cleared Traditional

K172975 - 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 (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

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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

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.