Cleared Special

K041160 - AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT

K041160 is an FDA 510(k) clearance for AVON EXTRA-SMALL PATELLO-FEMORAL REPLAC..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KRR cleared through the Special 510(k) pathway after a 24-day FDA review.

K041160 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
24d
Days
Class 2
Risk

K041160 is an FDA 510(k) clearance for the AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT. 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 May 27, 2004 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041160

510(k) Number K041160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date May 27, 2004
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 26
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K041160.
RBK PATELLA FEMORAL KNEE
K050473 · Global Orthopaedic Technology, USA, Inc. · Nov 2005
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948 · Howmedica Osteonics Corp. · Oct 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · Smith & Nephew, Inc. · May 2005
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT
K013982 · Kinamed, Inc. · May 2002
AVON PATELLAR COMPONENT
K020841 · Howmedica Osteonics Corp. · Apr 2002
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · Howmedica Osteonics Corp. · Apr 2001
K041160 · AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
Download PDF FDA Summary Howmedica Osteonics C…