Cadence Flat Cut Total Ankle System

Basic Information

• Brand Name: Cadence Flat Cut Total Ankle System
• Primary DI: 00816847022781
• Version / Model: Anatomical model
• Company Name: 3D SYSTEMS, INC.
• Labeler DUNS: 085049749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-10
• Public Version: 1
• Public Version Date: 2025-01-20
• Public Version Status: New
• Public Device Record Key: a49191e1-a3ff-4c24-b8bf-cd09b32435f1

Device Description

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan.

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OYK	Ankle Arthroplasty Implantation System	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62215	Custom-made organ/bone anatomy model	A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816847022781	GS1

Premarket Submissions

Submission Number	Supplement Number
K243174	000