510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K213349Substantially Equivalent

Catalyst R1 Reverse Shoulder System

CATALYST ORTHOSCIENCE Inc, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213349 is the FDA 510(k) clearance record for Catalyst R1 Reverse Shoulder System, a class II device, cleared for Catalyst Orthoscience, Inc. on under FDA product code PHX (Shoulder Prosthesis, Reverse Configuration). FDA's definition for product code PHX reads: "Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a...". FDA records list 13 510(k) clearances for Catalyst Orthoscience, Inc., from to . As of , FDA records show no recalls naming K213349.

Clearance record

Decision date
Received
(258 days to decision)
Product code
PHX Shoulder Prosthesis, Reverse Configuration
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Catalyst Orthoscience, Inc. 14710 Tamiami Trl., N., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHX

Trailing 12 months
16 clearances under product code PHX in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code PHX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20265
February 20261
March 20261
April 20264
May 20261
June 20263
July 20261
August 20260
September 20260
October 20260