Cleared Traditional

K161254 - Renovo Life Small Bone IM Nail System

K161254 is an FDA 510(k) clearance for Renovo Life Small Bone IM Nail System, manufactured by Renovo Life, LLC. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K161254 · Renovo Life, LLC · Orthopedic device
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Nov 2016
Decision
188d
Days
Class 2
Risk

K161254 is an FDA 510(k) clearance for the Renovo Life Small Bone IM Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Renovo Life, LLC (Belmont, US). The FDA issued a Cleared decision on November 7, 2016 after a review of 188 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 Renovo Life, LLC devices

FDA 510(k) Submission Details - K161254

510(k) Number K161254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2016
Decision Date November 07, 2016
Days to Decision 188 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 122d · This submission: 188d
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 380
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K161254.
PRECICE Intramedullary Limb Lengthening System
K170346 · Nuvasive Specialized Orthopedics, Inc. · Mar 2017
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K161466 · Orthofix Srl · Jan 2017
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016
DePuy Synthes TFNA Augmentation System
K160167 · Synthes USA Products, LLC · Sep 2016
Piccolo Composite® Nailing System
K153536 · CarboFix Orthopedics , Ltd. · Jan 2016
Cardinal Health Trochanteric IM Nail System
K150769 · Cardinalhealth · Dec 2015