510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003504Substantially Equivalent

Rt-Plus Modular Cemented Knee Components

Plus Orthopedics, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003504 is the FDA 510(k) clearance record for RT-PLUS MODULAR CEMENTED KNEE COMPONENTS, a class II device, cleared for Plus Orthopedics on under FDA product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer). FDA records list 43 510(k) clearances for Plus Orthopedics, from to . As of , FDA records show no recalls naming K003504.

Clearance record

Decision date
Received
(179 days to decision)
Product code
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3510
Device class
Class II
Review panel
Orthopedic
Applicant
Plus Orthopedics 3550 General Atomics Ct., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code KRO

Trailing 12 months
2 clearances under product code KRO in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRO, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260