Cleared Special

K150410 - RESTORIS POROUS PARTIAL KNEE SYSTEM

K150410 is an FDA 510(k) clearance for RESTORIS POROUS PARTIAL KNEE SYSTEM, manufactured by Mako Surgical Corporation. The device is a Class 2 Orthopedic device with product code HRY cleared through the Special 510(k) pathway after a 30-day FDA review.

K150410 · Mako Surgical Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
30d
Days
Class 2
Risk

K150410 is an FDA 510(k) clearance for the RESTORIS POROUS PARTIAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Mako Surgical Corporation (Fort Lauderdale, US). The FDA issued a Cleared decision on March 20, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150410

510(k) Number K150410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date March 20, 2015
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 90
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K150410.
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UNIVATION
K131167 · Aesculap Implant Systems, LLC · Oct 2013
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
K122277 · Biomet Manufacturing Corp · Oct 2012
K150410 · RESTORIS POROUS PARTIAL KNEE SYSTEM
Download PDF FDA Summary Mako Surgical Corpora…