Who else makes this device?

Name: Shoulder Innovations IM Cut Guide
Brand: Shoulder Innovations IM Cut Guide

Shoulder Innovations IM Cut Guide · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented → Orthopedic

5manufacturers in China registered for this device type

6catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (3), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MBF
Manufacturer	City	Province	Registered as	Device types
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
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

Record

Regulatory record for Shoulder Innovations IM Cut Guide
Listed by	Shoulder Innovations, Inc, United States
FDA product code	MBF
Device type	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device class	Class 2
Regulation	21 CFR 888.3670
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K102670
Record published	2025-04-18

Specifications

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

Catalogue Numbers

Catalogue numbers for Shoulder Innovations IM Cut Guide
Catalogue number	Size	Status
IM Cut Guide Subscapularis Sparing Cut Guide Hanger		In distribution
IM Cut Guide Subscapularis Sparing Cut Block Assembly		In distribution
IM Cut Guide, Delto-Pectoral Cut Guide		In distribution
IM Cut Guide Superior-Lateral Fixed Arm Assembly		In distribution
IM Cut Guide, Delto-Pectoral Fixed Arm Assembly		In distribution
IM Cut Guide T-Handle		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Shoulder Innovations Inset Reverse Total Shoulder	Shoulder Innovations, Inc	181
Shoulder Innovations Humeral Short Stem System	Shoulder Innovations, Inc	87
Comprehensive® Shoulder System	Biomet Orthopedics	70
BIO-Modular Shoulder System	Biomet Orthopedics	41
Shoulder Innovations InSet 95 Humeral Stem	Shoulder Innovations, Inc	40
Comprehensive® SRS Instrument	Biomet Orthopedics	36
Identity™	Zimmer, Inc.	29
Comprehensive® SRS	Biomet Orthopedics	25
Inhance	Depuy (Ireland)	25
SMR Shoulder	Limacorporate	20
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Synthes (U.S.A.) LP	19
BI-Angular System	Biomet Orthopedics	16

Showing 12 of 71. All products under Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K173824	2018-10-23

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.

Shoulder Innovations IM Cut Guide