Cleared Traditional

MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II

K082088 · Mako Surgical Corp. · Orthopedic

Oct 2008

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K082088 is an FDA 510(k) clearance for the MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Mako Surgical Corp. (Fort Lauderdale, US). The FDA issued a Cleared decision on October 22, 2008, 90 days after receiving the submission on July 24, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K082088 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2008
Decision Date	October 22, 2008
Days to Decision	90 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