# K250844: PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

- Pathway: 510(k) (Traditional)
- Applicant: Science & Bio Materials (S.B.M.) Sas
- Decided: Jun 2, 2025 after 74 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: 11 generations back to K904436 (1990). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, S.B.M. Sas (Science & Bio Materials) (2020) Summary page 5.
- K151004: PULLUP® Adjustable Juxtacortical Fixation Device, Sbm Sciences For Bio Materials (2015) Summary page 5.

## Indications for use
Transplant. The PULLUP®, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament. - PULLUP®, PULLUP® CLIP, PULLUP® TEX CLIP must be used with a Soft Tissue Transplant. - BT LOOP® must be used with a Bone Tendon Bone Transplant. The RIGIDLOOP™ T, RIGIDLOOP™ BTB, RIGIDLOOP™ Clip and RIGIDLOOP™ Suture Loop cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament. - RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ Suture Loop must be used with a Soft Tissue - RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant.

Source page: https://510kreport.com/device/K250844
Methodology: https://510kreport.com/methodology