Shoulder Innovations InSet FxR 135

Basic Information

• Brand Name: Shoulder Innovations InSet FxR 135
• Primary DI: B1132L1S0800020
• Version / Model: 8mmX135
• Catalog Number: 2L1S080002
• Company Name: Shoulder Innovations, Inc.
• Labeler DUNS: 080404519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-12
• Public Version: 1
• Public Version Date: 2025-12-22
• Public Version Status: New
• Public Device Record Key: 21ef2fa2-7425-402e-92c0-49578fe756bd

Device Description

Shoulder Innovations - InSet FxR 135 - 8mmX135

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	888.3650	2
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	888.3660	2
MBX	Stimulator, Thalamic, Epilepsy, Implanted	Unknown		3
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	888.3660	2
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	888.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35670	Total shoulder prosthesis	A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active
39702	Coated shoulder humeral stem prosthesis	A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1132L1S0800020	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]