Cleared Traditional

K120262 - HLS UNI EVOLUTION & U-KNEETEC

K120262 is an FDA 510(k) clearance for HLS UNI EVOLUTION & U-KNEETEC, manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K120262 · Tornier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
180d
Days
Class 2
Risk

K120262 is an FDA 510(k) clearance for the HLS UNI EVOLUTION & U-KNEETEC. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Tornier, Inc. (Montbonnot, FR). The FDA issued a Cleared decision on July 25, 2012 after a review of 180 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 Tornier, Inc. devices

FDA 510(k) Submission Details - K120262

510(k) Number K120262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date July 25, 2012
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 112
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K120262.
STRIDE UNICONDYLAR KNEE
K123380 · Blue Belt Technologies, Inc. · May 2013
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
K122529 · Zimmer, Inc. · Nov 2012
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K121974 · Conformis, Inc. · Sep 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
K112301 · Materialise NV · Jan 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
K113038 · Smith & Nephew, Inc. · Jan 2012
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K111916 · Conformis, Inc. · Sep 2011