Cleared Traditional

K080029 - MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM

K080029 is an FDA 510(k) clearance for MAKO SURGICAL CORP. PATELLOFEMORAL KNEE..., manufactured by Mako Surgical Corp.. The device is a Class 2 Orthopedic device with product code KRR cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K080029 · Mako Surgical Corp. · Orthopedic device
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May 2008
Decision
133d
Days
Class 2
Risk

K080029 is an FDA 510(k) clearance for the MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Mako Surgical Corp. (Ft. Lauderdale, US). The FDA issued a Cleared decision on May 16, 2008 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mako Surgical Corp. devices

FDA 510(k) Submission Details - K080029

510(k) Number K080029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2008
Decision Date May 16, 2008
Days to Decision 133 days
Submission Type Traditional
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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 25
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K080029.
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