Cleared Traditional

K191336 - PRECICE System

K191336 is an FDA 510(k) clearance for PRECICE 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 132-day FDA review.

K191336 · Nuvasive Specialized Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
132d
Days
Class 2
Risk

K191336 is an FDA 510(k) clearance for the PRECICE 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 September 26, 2019 after a review of 132 days - within the typical 510(k) review window.

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 Nuvasive Specialized Orthopedics, Inc. devices

FDA 510(k) Submission Details - K191336

510(k) Number K191336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2019
Decision Date September 26, 2019
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K191336.
EBA One Nailing System
K183666 · Citieffe S.R.L. · Nov 2019
Zimmer Natural Nail System Cephalomedullary Nails
K192312 · Zimmer GmbH · Oct 2019
Pediatric Nailing PlatformFemur
K190321 · OrthoPediatrics Corp. · Oct 2019
TTC Phantom Intramedullary Nail System
K191782 · Paragon 28, Inc. · Sep 2019
Syntec Tibial Nail System
K191617 · Syntec Scientific Corporation · Sep 2019
AOS ES Retrograde Femoral Nail
K191598 · Advanced Orthopaedic Solutions, Inc. · Jul 2019