AccessGUDID - DEVICE: Ascension® Silicone PIP (10381780116349)

GUDID

Device Identifier (DI) Information

Brand Name: Ascension® Silicone PIP
Version or Model: SPIP5205WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SPIP-520-5-WW
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780116349
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Ascension silicone PIP is an anatomically designed, single use, one piece, flexible hinge prosthesis designed to be implanted without bone cement across the proximal interphalangeal (PIP) joint. It is made from medical grade silicone elastomer. The proximal and distal stems of the prosthesis are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. the PIP provides 90 degrees of flexion from full extension. The Ascension PIP finger joint prostheses is intended for cementless replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
60459	Proximal interphalangeal joint prosthesis, modular	A sterile, implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. The device typically consists of proximal and distal metal (e.g., titanium) stems, which may be coated with a material (e.g., hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth, for insertion into the prepared phalanges of the joint. The stems may have articulating surfaces or there may be separate metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic ( e.g., polyethylene) articulating surface components. Dedicated tools for implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KYJ	PROSTHESIS, FINGER, CONSTRAINED, POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082231	000

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
Device Size Text, specify: Size 5

Device Record Status

Public Device Record Key: 7c8d9408-9706-47f1-9049-0eaa230dce95
Public Version Date: February 23, 2023
Public Version Number: 6
DI Record Publish Date: October 09, 2017