Who else makes this device?

Name: SurgiCase Planner
Brand: SurgiCase Planner

SurgiCase Planner · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented → Orthopedic

9manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWS
Manufacturer	City	Province	Registered as	Device types
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	10
Stryker Trauson (Changzhou) Medical Technology Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	3
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for SurgiCase Planner
Listed by	Materialise NV, Belgium
FDA product code	KWS
Device type	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class	Class 2
Regulation	21 CFR 888.3660
Record published	2018-10-17
Record revised	2025-03-10 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for SurgiCase Planner
Catalogue number	Size	Status
SurgiCase Shoulder Planner		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Equinoxe	Exactech, Inc.	442
Reunion	Stryker GmbH	321
DJO Surgical	Encore Medical, L.P.	266
SMR Shoulder	Limacorporate	209
Tornier Flex Shoulder System	Tornier Inc.	187
Anatomical Shoulder™	Zimmer, Inc.	166
Arthrex®	Arthrex, Inc.	154
Comprehensive Shoulder System	Biomet Orthopedics	111
Flex Shoulder System	Tornier Inc.	109
Aequalis™ PerFORM+	Tornier Inc.	108
Aequalis™ Ascend™ Flex	Tornier Inc.	102
Anatomic Shoulder Prosthesis	Medacta International SA	90

Showing 12 of 326. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190286	2019-07-08
K172054	2017-11-03
K170893	2017-06-19
K153602	2016-04-26
K131559	2013-09-27

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.

SurgiCase Planner