Cleared Traditional

K172872 - DePuy Synthes Femoral Neck System

K172872 is an FDA 510(k) clearance for DePuy Synthes Femoral Neck System, manufactured by DePuy Synthes. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K172872 · DePuy Synthes · Orthopedic device
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Mar 2018
Decision
165d
Days
Class 2
Risk

K172872 is an FDA 510(k) clearance for the DePuy Synthes Femoral Neck System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by DePuy Synthes (Zuchwil, CH). The FDA issued a Cleared decision on March 5, 2018 after a review of 165 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 DePuy Synthes devices

FDA 510(k) Submission Details - K172872

510(k) Number K172872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date March 05, 2018
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 353
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K172872.
External Fixation System
K173883 · Life Spine, Inc. · Sep 2018
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K180580 · Surgical Instrument Service and Savings, Inc. · Jul 2018
SALVATION External Fixation System
K180832 · Wrightmedicaltechnologyinc · Jun 2018
ARBOR External Fixation System
K172438 · Globus Medical, Inc. · Jan 2018
Medline ReNewal Reprocessed Synthes External Fixation Systems
K171911 · Surgical Instrument Service and Savings, Inc. · Nov 2017
Galaxy UNYCO System
K170146 · Orthofix Srl · Oct 2017