Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012552981

FEI Number

3012552981

Entity Name

CATALYST ORTHOSCIENCE Inc

City/State/Country

Naples, FL, US

Establishment Address

14710 Tamiami Trail N., Suite #102, Naples, FL 34110, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Catalyst Orthoscience (Owner Number: 10051942)

Owner / Operator Contact Address

14710 Tamiami Trail N., Suite #102, Naples, FL 34110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182500

PMA Number

N/A

All Registered Proprietary Names

Catalyst Shoulder Archer CSR Total Shoulder System Catalyst F1x Shoulder System Catalyst R1 Reverse Shoulder System CSR Catalyst R1 Reverse Shoulder System Catalyst EA Convertible Stemmed Shoulder Catalyst CSR 3 Peg Glenoids Archer CSR Total Shoulder System Catalyst R1 Reverse Shoulder System Catalyst R1 Reverse Shoulder System Catalyst CSR Shoulder System Archer CSR Total Shoulder System Catalyst CSR Shoulder System Archer CSR Total Shoulder System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-09-17
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-12-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-12-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-12-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-04-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-05-23
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-08-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-08-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-08-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-08-30
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-08-30
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-04-17
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-08-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-08-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-08-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-08-30
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-07-17
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-07-17
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-05-08
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-05-08

Official Correspondent

Dale Davison

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Catalyst Orthoscience

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2019	Exactech, Inc.	2	Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012552981. Last updated year: 2026. Please use registration number 3012552981 when referencing this establishment in official correspondence.