Cleared Traditional

HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM

K071413 · Arthrosurface, Inc. · Orthopedic

Nov 2007

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K071413 is an FDA 510(k) clearance for the HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM, 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 November 9, 2007, 172 days after receiving the submission on May 21, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K071413 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2007
Decision Date	November 09, 2007
Days to Decision	172 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