Patient Specific Talus Spacer

Basic Information

• Brand Name: Patient Specific Talus Spacer
• Primary DI: 00889795137203
• Version / Model: AOPSTSXXXXN
• Catalog Number: AOPSTSXXXXN
• Company Name: Paragon 28, Inc.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-07
• Public Version: 2
• Public Version Date: 2025-04-22
• Public Version Status: Update
• Public Device Record Key: 2778e004-610a-4fc8-88ff-75076a2ec55c

Device Description

Patient Specific Talus Spacer, Nominal, CoCr

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNN	Prosthesis, Total Talus Replacement, Metal	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
48181	Coated ankle talus prosthesis	A sterile implantable device designed to replace the proximal talus (talar component) as part of a primary ankle joint replacement or prosthesis revision. 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	00889795137203	GS1

Premarket Submissions

Submission Number	Supplement Number
H200001	000