Cleared Traditional

HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS (K060127) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060127 · Arthrosurface, Inc. · Orthopedic device
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Mar 2006
Decision
57d
Days
Class 2
Risk

K060127 is an FDA 510(k) clearance for the HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 57 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrosurface, Inc. devices

Submission Details

510(k) Number K060127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2006
Decision Date March 16, 2006
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K060127.
Arthrex iBalance BiCompartmental Arthroplasty System
K160461 · Arthrex, Inc. · Apr 2016
Prelude PF Patellae
K143543 · Biomet, Inc. · Jan 2015
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
K070695 · Zimmer, Inc. · Jun 2007
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