Cleared Traditional

K050473 - RBK PATELLA FEMORAL KNEE

K050473 is an FDA 510(k) clearance for RBK PATELLA FEMORAL KNEE, manufactured by Global Orthopaedic Technology, USA, Inc.. The device is a Class 2 Orthopedic device with product code KRR cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K050473 · Global Orthopaedic Technology, USA, Inc. · Orthopedic device
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Nov 2005
Decision
263d
Days
Class 2
Risk

K050473 is an FDA 510(k) clearance for the RBK PATELLA FEMORAL KNEE. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Global Orthopaedic Technology, USA, Inc. (Oviedo, US). The FDA issued a Cleared decision on November 14, 2005 after a review of 263 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - 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 - K050473

510(k) Number K050473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2005
Decision Date November 14, 2005
Days to Decision 263 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
141d slower than avg
Panel avg: 122d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRR Device Classification - Class 2, Special Controls

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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 - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 24
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K050473.
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM
K071413 · Arthrosurface, Inc. · Nov 2007
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
K070695 · Zimmer, Inc. · Jun 2007
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
K060127 · Arthrosurface, Inc. · Mar 2006
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948 · Howmedica Osteonics Corp. · Oct 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · Smith & Nephew, Inc. · May 2005
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
K041160 · Howmedica Osteonics Corp. · May 2004