Science & Bio Materials (S.B.M.) Sas · Class II · Cleared Jun 2, 2025
| K-number | K250844 |
| Device name | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop |
| Applicant | Science & Bio Materials (S.B.M.) Sas |
| Product code | MBI |
| Device class | Class II |
| Decision date | Jun 2, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The PULLUP®, PULLUP® CLIP, BT LOOP®, PULLUP® TEX CLIP, RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ BTB, and RIGIDLOOP™ Suture Loop are cortical fixation devices indicated in adults for reconstruction of the anterior cruciate ligament. PULLUP and RIGIDLOOP variants with soft tissue transplants use titanium button-plates with adjustable nonabsorbable braided loops; BTB versions are designed for bone-tendon-bone grafts. The devices are supplied sterile and ready to use in standard and XL sizes.
The subject devices are substantially equivalent to the predicate in intended use, material (titanium), design (button-plate with adjustable braided loop), mechanical properties, and function. Minor design differences include sizing variations (standard and XL for different cortical tunnel diameters of 4.5 mm or 5–10 mm respectively) and trade name rebranding as RIGIDLOOP™ variants, but these do not raise safety or effectiveness concerns.
ISO 10993-1:2018 (biocompatibility); ISO 11737-1:2006 (sterile adoption); ISO 11737-3 (2023) (bacterial endotoxin testing); ISO 11607-1:2019 (packaging); ASTM F2503-20 and IEC 62570:2014 (MRI safety); FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.
The predicate devices (K202193 and K151004) and subject devices share identical intended use (ACL reconstruction), material composition (titanium), basic design architecture (button-plate with braided loop), and mechanical performance. Non-clinical testing demonstrated that ultimate failure load, fatigue displacement, biocompatibility, and shelf-life characteristics meet or exceed predicate acceptance criteria. There is no change in material, sterilization method, or shelf-life. Minor design variations (sizing for different tunnel diameters) and rebranding as RIGIDLOOP™ do not introduce new or different safety questions, as mechanical properties and performance remain equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov