Cleared Traditional

K162927 - PRECICE UNYTE CoCr System

K162927 is an FDA 510(k) clearance for PRECICE UNYTE CoCr 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 169-day FDA review.

K162927 · Nuvasive Specialized Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
169d
Days
Class 2
Risk

K162927 is an FDA 510(k) clearance for the PRECICE UNYTE CoCr 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 April 6, 2017 after a review of 169 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.

FDA 510(k) Submission Details - K162927

510(k) Number K162927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2016
Decision Date April 06, 2017
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
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 511
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K162927.
SIGN IM Nail
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K170169 · Nuvasive Specialized Orthopedics, Inc. · Jun 2017
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K161327 · Syntec Scientific Corporation · Jun 2017
Flex-Thread Clavicle Pin System
K163488 · Intrafuse, LLC · Mar 2017
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K170346 · Nuvasive Specialized Orthopedics, Inc. · Mar 2017
Sonoma Fifth Metatarsal Repair System
K161371 · Sonoma Orthopedic Products, Inc. · Feb 2017