AccessGUDID - DEVICE: Triathlon AS-1 PS Box Ream Cementless Instrumentation Kit (M5726556C012011)

GUDID

Device Identifier (DI) Information

Brand Name: Triathlon AS-1 PS Box Ream Cementless Instrumentation Kit
Version or Model: 6556C01201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6556-C-012
Company Name: Conformis, Inc.

Primary DI Number: M5726556C012011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808821883 *Terms of Use

Device Description: Triathlon AS-1 PS Surgical Instruments, Cementless, PS insert, box ream, sizes 0-8, Right and Left

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:	Yes
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?
58910	Total knee prosthesis implantation guide-instrument kit	A collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOG	Knee Arthroplasty Implantation System
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203421	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: Femur prep size 0 to size 8; tibial prep size 0 to size 8

Device Record Status

Public Device Record Key: ae5faf44-9224-4441-b07a-9c251c53a3e0
Public Version Date: May 10, 2021
Public Version Number: 1
DI Record Publish Date: April 30, 2021