# K232886: INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

- Pathway: 510(k) (Traditional)
- Applicant: Healthium Medtech Limited
- Decided: Nov 8, 2023 after 51 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: 10 generations back to K792022 (1979). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 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 5.
- K130814: Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 5.

## Indications for use
The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL).

Source page: https://510kreport.com/device/K232886
Methodology: https://510kreport.com/methodology