# K153186: Adjustable Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Arthrocare Corp.
- Decided: Jan 28, 2016 after 86 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 K904436 (1990). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 4.
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 4.
- K133606: N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various Class I Ancill, ArthroCare Corporation (2014) Summary page 4.

## Most influential descendants
- K222971: ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device (2023), 0 descendants of its own

## Indications for use
The Adjustable Fixation Device is indicated for soft tissue to bone fixation for: • ACL/PCL repair / reconstruction • ACL/PCL patellar bone-tendon-bone grafts • Double-Tunnel ACL reconstruction • Extracapsular repair: MCL, LCL, and posterior oblique ligament • Illiotibial band tenodesis • Patellar tendon repair • VMO advancement • Joint capsule closure

Source page: https://510kreport.com/device/K153186
Methodology: https://510kreport.com/methodology