# 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

- Pathway: 510(k) (Special)
- Applicant: S.B.M. Sas (Science & Bio Materials)
- Decided: Oct 16, 2020 after 72 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). 62 ancestors in all.
1 later device descends from it; 1 cites 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)
- K151004: PULLUP® Adjustable Juxtacortical Fixation Device, Sbm Sciences For Bio Materials (2015) Summary page 5.

## Most influential descendants
- 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® BTB, BT LOOP®, PULLUP® CLIP & PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.

Source page: https://510kreport.com/device/K202193
Methodology: https://510kreport.com/methodology