Cleared Traditional

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

K060127 · Arthrosurface, Inc. · Orthopedic

Mar 2006

Decision

57d

Days

Class 2

Risk

K060127 is an FDA 510(k) clearance for the HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on March 16, 2006, 57 days after receiving the submission on January 18, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K060127 FDA.gov
FDA Decision	Cleared 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

Device Classification

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