# K191204: Infinity Fixation System

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: Jul 3, 2019 after 58 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K792022 (1979). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070780: Conmed Linvatec XO Button, Conmed Linvatec (2007) Summary page 4.
- K151037: GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle, Conmed Corporation (2015) Summary page 4.

## Indications for use
The InfinityTM Fixation System is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament.

Source page: https://510kreport.com/device/K191204
Methodology: https://510kreport.com/methodology