What is FDA product code PKC?

Replacement of the humeral head for total anatomic shoulder arthroplasty

Global Advantage · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem with No Diaphyseal Incursion, Semi-Constrained → Orthopedic

Name: Global Advantage
Brand: Global Advantage

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Shanghai.

Chinese manufacturers registered for FDA product code PKC
Manufacturer	City	Province	Registered as	Device types
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38

Record

Regulatory record for Global Advantage
Listed by	Depuy (Ireland), Ireland
FDA product code	PKC
Device type	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device class	Class 2
Regulation	21 CFR 888.3660
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Record published	2018-06-15
Record revised	2024-03-26 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Global Advantage
Catalogue number	Size	Status
2128-61-071		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Comprehensive® Shoulder System	Biomet Orthopedics	83
Equinoxe	Exactech, Inc.	60
SMR Stemless	Limacorporate	51
Global Icon	Depuy (Ireland)	50
Sidus® Stem-Free Shoulder	Zimmer, Inc.	39
OsseoFit™ Stemless Shoulder	Zimmer, Inc.	38
DJO Surgical	Encore Medical, L.P.	32
Tornier Simpliciti® Shoulder System	Tornier Inc.	27
Simpliciti™	Tornier Inc.	27
Arthrex®	Arthrex, Inc.	21
Tornier Perform	Tornier Inc.	10
FX V135	Fx Solutions	10

Showing 12 of 19. All products under Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K212683	2022-01-19

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Global Advantage