Cleared Traditional

K050764 - UNIGLIDE UNICONDYLAR KNEE PROSTHESIS

K050764 is an FDA 510(k) clearance for UNIGLIDE UNICONDYLAR KNEE PROSTHESIS, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K050764 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
153d
Days
Class 2
Risk

K050764 is an FDA 510(k) clearance for the UNIGLIDE UNICONDYLAR KNEE PROSTHESIS. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on August 24, 2005 after a review of 153 days - an extended review cycle.

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 Corin USA devices

FDA 510(k) Submission Details - K050764

510(k) Number K050764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2005
Decision Date August 24, 2005
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
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 76
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K050764.
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
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · Biomet, Inc. · Nov 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · Exactech, Inc. · Oct 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268 · DePuy Orthopaedics, Inc. · May 2004