# K151004: PULLUP® Adjustable Juxtacortical Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Sbm Sciences For Bio Materials
- Decided: Nov 17, 2015 after 216 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 K904436 (1990). 61 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle, Arthrex, Inc. (2011) 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.

## Most influential descendants
- K202193: PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction (2020), 1 descendant of its own
- K250844: PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop (2025), 0 descendants of its own

## Indications for use
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.

Source page: https://510kreport.com/device/K151004
Methodology: https://510kreport.com/methodology