Cleared Traditional

K172061 - PRECICE UNYTE System

K172061 is an FDA 510(k) clearance for PRECICE UNYTE System, manufactured by Nuvasive Specialized Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K172061 · Nuvasive Specialized Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
48d
Days
Class 2
Risk

K172061 is an FDA 510(k) clearance for the PRECICE UNYTE System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Nuvasive Specialized Orthopedics, Inc. (Alisa Viejo, US). The FDA issued a Cleared decision on August 24, 2017 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuvasive Specialized Orthopedics, Inc. devices

FDA 510(k) Submission Details - K172061

510(k) Number K172061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2017
Decision Date August 24, 2017
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 378
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K172061.
DePuy Synthes Femoral Recon Nail System
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PRECICE System
K172628 · Nuvasive Specialized Orthopedics, Inc. · Sep 2017
Shotel Ankle Arthrodesis Nail System
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Zimmer Natural Nail System
K172114 · Zimmer, Inc. · Aug 2017
PRECICE Intramedullary Limb Lengthening System
K170169 · Nuvasive Specialized Orthopedics, Inc. · Jun 2017
PRECICE UNYTE CoCr System
K162927 · Nuvasive Specialized Orthopedics, Inc. · Apr 2017