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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Orgenix, LLC
Donald W. Guthner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K161254.
AOS Small Bone Nailing System
K163014 · Advanced Orthopaedic Solutions, Inc. (Aos) · Jan 2017
GAP ENDO-EXO MEDULLARY SYSTEM
K160545 · Pega Medical, Inc. · Nov 2016
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016
DePuy Synthes TFNA Augmentation System
K160167 · Synthes USA Products, LLC · Sep 2016
PRECICE Intramedullary Limb Lengthening System
K160325 · Ellipse Technologies, Inc. · Apr 2016
PRECICE Trauma Nail System
K160267 · Ellipse Technologies, Incorporated · Mar 2016