Cleared Traditional

K051721 - GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM

K051721 is an FDA 510(k) clearance for GLOBAL RESURFACING UNICOMPARTMENTAL KNE..., manufactured by Global Orthopaedic Technology, USA, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K051721 · Global Orthopaedic Technology, USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
121d
Days
Class 2
Risk

K051721 is an FDA 510(k) clearance for the GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Global Orthopaedic Technology, USA, Inc. (Oviedo, US). The FDA issued a Cleared decision on October 26, 2005 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 Global Orthopaedic Technology, USA, Inc. devices

FDA 510(k) Submission Details - K051721

510(k) Number K051721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date October 26, 2005
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 80
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K051721.
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
K063515 · Biomet Manufacturing, Inc. · Feb 2007
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
K061681 · Biomet Manufacturing Corp · Oct 2006
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
K053299 · Biomet Manufacturing, Inc. · Jan 2006
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
K050764 · Corin USA · Aug 2005
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · Biomet, Inc. · Nov 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · Exactech, Inc. · Oct 2004