510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133811Substantially Equivalent

Restoris Porous Partial Knee System

Mako Surgical Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133811 is the FDA 510(k) clearance record for RESTORIS POROUS PARTIAL KNEE SYSTEM, a class II device, cleared for Mako Surgical Corp. on under FDA product code NJD (Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer). FDA's definition for product code NJD reads: "Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and...". FDA records list 42 510(k) clearances for Mako Surgical Corp., from to . As of , FDA records show no recalls naming K133811.

Clearance record

Decision date
Received
(204 days to decision)
Product code
NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Regulation
21 CFR 888.3535
Device class
Class II
Review panel
Orthopedic
Applicant
Mako Surgical Corp. 575 Eighth Ave., New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJD

Trailing 12 months

FDA records hold no clearances under product code NJD in the trailing twelve months.

FDA records show no clearances under product code NJD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NJD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260