AccessGUDID - DEVICE: APEX 3D Total Ankle Replacement System (00889795119681)

GUDID

Device Identifier (DI) Information

Brand Name: APEX 3D Total Ankle Replacement System
Version or Model: P10-31A-I416-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P10-31A-I416-S
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795119681
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 16MM, 3.75MM ANT OFFSET

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33718	Fixed-bearing total ankle prosthesis	A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e05bc808-e85f-4ef3-9ba9-837a08d0a868
Public Version Date: April 22, 2025
Public Version Number: 2
DI Record Publish Date: October 21, 2022