Cleared Traditional

K193617 - Precice Screws

K193617 is the FDA 510(k) clearance for Precice Screws by Nuvasive Specialized Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K193617 · Nuvasive Specialized Orthopedics, Inc. · Orthopedic device
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May 2020
Decision
134d
Days
Class 2
Risk

K193617 is an FDA 510(k) clearance for the Precice® Screws. 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 May 8, 2020 after a review of 134 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

Submission Details

510(k) Number K193617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2019
Decision Date May 08, 2020
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K193617.
T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
K200880 · Stryker GmbH · Jul 2020
The Simple Locking Intramedullary (Slim) System
K192710 · Pega Medical, Inc. · Jun 2020
PRECICE Bone Transport System
K193016 · Nuvasive Specialized Orthopedics, Inc. · May 2020
Affixus(R) Natural Nail(R) System Humeral Nail
K200814 · Zimmer GmbH · Apr 2020
T2 Alpha Tibia Nailing System, IMN Screws System
K193308 · Stryker Trauma GmbH · Feb 2020
TTC Phantom® Intramedullary Nail System
K192163 · Paragon 28, Inc. · Jan 2020