Cleared Traditional

K033351 - GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE

K033351 is an FDA 510(k) clearance for GLOBAL RESURFACING UNICOMPARTMENTAL (GR..., 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 143-day FDA review.

K033351 · Global Orthopaedic Technology, USA, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
143d
Days
Class 2
Risk

K033351 is an FDA 510(k) clearance for the GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE. 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 March 11, 2004 after a review of 143 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 - K033351

510(k) Number K033351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2003
Decision Date March 11, 2004
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
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 K033351.
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