Cleared Traditional

K051948 - AVON PATELLO-FEMORAL JOINT PROSTHESIS

K051948 is an FDA 510(k) clearance for AVON PATELLO-FEMORAL JOINT PROSTHESIS, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KRR cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K051948 · Howmedica Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2005
Decision
95d
Days
Class 2
Risk

K051948 is an FDA 510(k) clearance for the AVON PATELLO-FEMORAL JOINT PROSTHESIS. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on October 21, 2005 after a review of 95 days - within the typical 510(k) review window.

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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K051948

510(k) Number K051948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2005
Decision Date October 21, 2005
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 K051948.
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
K070695 · Zimmer, Inc. · Jun 2007
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
K060127 · Arthrosurface, Inc. · Mar 2006
RBK PATELLA FEMORAL KNEE
K050473 · Global Orthopaedic Technology, USA, Inc. · Nov 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · Smith & Nephew, Inc. · May 2005
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
K041160 · Howmedica Osteonics Corp. · May 2004
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
K013982 · Kinamed, Inc. · May 2002