Cleared Traditional

K022211 - HLS UNI EVOLUTION PROSTHESIS

K022211 is an FDA 510(k) clearance for HLS UNI EVOLUTION PROSTHESIS, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K022211 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
318d
Days
Class 2
Risk

K022211 is an FDA 510(k) clearance for the HLS UNI EVOLUTION PROSTHESIS. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Tornier (Montbonnot, FR). The FDA issued a Cleared decision on May 22, 2003 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 devices

FDA 510(k) Submission Details - K022211

510(k) Number K022211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2002
Decision Date May 22, 2003
Days to Decision 318 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
196d slower than avg
Panel avg: 122d · This submission: 318d
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 109
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K022211.
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · Howmedica Osteonics Corp. · Feb 2004
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · Zimmer, Inc. · Jan 2004
STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · Stelkast Company · Nov 2003
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · Sulzer Orthopedics, Inc. · Sep 2001
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
K010685 · Zimmer, Inc. · Apr 2001
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
K992287 · Howmedica Osteonics Corp. · Nov 1999