Cleared Traditional

K160167 - DePuy Synthes TFNA Augmentation System

K160167 is an FDA 510(k) clearance for DePuy Synthes TFNA Augmentation System, manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K160167 · Synthes USA Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
243d
Days
Class 2
Risk

K160167 is an FDA 510(k) clearance for the DePuy Synthes TFNA Augmentation System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on September 26, 2016 after a review of 243 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 devices

FDA 510(k) Submission Details - K160167

510(k) Number K160167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date September 26, 2016
Days to Decision 243 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
121d slower than avg
Panel avg: 122d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 461
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K160167.
GAP ENDO-EXO MEDULLARY SYSTEM
K160545 · Pega Medical, Inc. · Nov 2016
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016
Renovo Life Small Bone IM Nail System
K161254 · Renovo Life, LLC · Nov 2016
PRECICE Intramedullary Limb Lengthening System
K160325 · Ellipse Technologies, Inc. · Apr 2016
PRECICE Trauma Nail System
K160267 · Ellipse Technologies, Incorporated · Mar 2016
Sonoma Fibula Repair System
K160069 · Sonoma Orthopedics Products, Inc. · Mar 2016