Triathlon AS-1 CR Cementless Instrumentation Kit

Basic Information

• Brand Name: Triathlon AS-1 CR Cementless Instrumentation Kit
• Primary DI: M5726556C002011
• Version / Model: 6556C00201
• Catalog Number: 6556-C-002
• Company Name: Conformis, Inc.
• Labeler DUNS: 808821883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 2
• Public Version Date: 2021-05-11
• Public Version Status: Update
• Public Device Record Key: b17b4d59-38b3-4b2f-880e-dafd060edc59

Device Description

Triathlon AS-1 CR Surgical Instruments, CR Femur, CR Insert, cementless Tibia, sizes 0-8 Right and Left

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOG	Knee Arthroplasty Implantation System	Orthopedic	888.3560	2
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M5726556C002011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203421	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Femur prep size 0 to size 8; tibial prep size 0 to size 8