APEX 3D S Total Ankle Replacement System

Basic Information

• Brand Name: APEX 3D S Total Ankle Replacement System
• Primary DI: 00889795140517
• Version / Model: P11-851-TP12
• Catalog Number: P11-851-TP12
• Company Name: Paragon 28, Inc.
• Labeler DUNS: 042961576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-17
• Public Version: 3
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: 46b936c1-5f88-4bd0-9ce4-5225935856db

Device Description

Short Stem Tibia, Instrument, Impaction Protector (Size 1+2)

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66646	Orthopaedic implant impactor, single-use	A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889795140517	GS1

Premarket Submissions

Submission Number	Supplement Number
K240259	000