Link OptiStem

Basic Information

• Brand Name: Link OptiStem
• Primary DI: 04026575283019
• Version / Model: 17-1100/11
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Labeler DUNS: 315675488
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-26
• Public Version: 1
• Public Version Date: 2023-02-03
• Public Version Status: New
• Public Device Record Key: 92647183-84b2-4404-a893-b07fcd377e94

Device Description

Modular stem, uncemented, Ti6Al4V, oval

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61561	Body femoral/tibial extension stem, uncoated	A sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of uncoated metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Fixation devices for implantation (e.g., screws and bolts) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04026575283019	GS1

Premarket Submissions

Submission Number	Supplement Number
K220628	000