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

K250844 · Science & Bio Materials (S.B.M.) Sas · MBI · Jun 2, 2025 · Orthopedic

Device Facts

Record IDK250844
Device NamePULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop
ApplicantScience & Bio Materials (S.B.M.) Sas
Product CodeMBI · Orthopedic
Decision DateJun 2, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3040
Device ClassClass 2
AttributesTherapeutic

Intended Use

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 Transplant. - RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant.

Device Story

Cortical fixation system for ACL reconstruction; comprises titanium button-plate and adjustable nonabsorbable braided loop; preloaded with traction and flip threads. Used in orthopedic surgery; implanted by surgeons to secure soft tissue or bone-tendon-bone grafts to bone. Provides mechanical fixation of graft within cortical tunnels; facilitates graft tensioning during reconstruction. Supplied sterile; ready for use. Benefits include stable graft fixation to promote ligament healing.

Clinical Evidence

Bench testing only. Testing included ultimate failure load, post-fatigue tensile strength, fatigue displacement, biocompatibility (ISO 10993-1:2018), bacterial endotoxin (ISO 11737-3), packaging integrity (ISO 11607-1:2019), sterilization validation (ISO 11137-1:2006), and MRI safety (ASTM F2503-20, IEC 62570:2014).

Technological Characteristics

Titanium button-plate; nonabsorbable braided loop. Standard (4.5 mm tunnels) and XL (5-10 mm tunnels) sizes. Sterile, single-use. MRI safe per ASTM F2503-20.

Indications for Use

Indicated for adults undergoing anterior cruciate ligament (ACL) reconstruction. Requires use with either soft tissue transplant or bone-tendon-bone transplant depending on specific device model.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION June 2, 2025 Science & Bio Materials (S.B.M.) SAS Anne Cospin Quality & Regulatory Affairs Director ZI du Monge Lourdes, 65100 France Re: K250844 Trade/Device Name: PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 20, 2025 Received: March 20, 2025 Dear Anne Cospin: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250844 - Anne Cospin Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2} K250844 - Anne Cospin Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CHRISTOPHER FERREIRA -S Christopher Ferriera, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250844 Device Name PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop Indications for Use (Describe) 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 Transplant. - RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov > "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} 510(k) #: K250844 510(k) Summary Prepared on: 2025-05-20 # Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Science & Bio Materials (S.B.M.) SAS | | --- | --- | | Applicant Address | ZI du Monge Lourdes 65100 France | | Applicant Contact Telephone | 33562422101 | | Applicant Contact | Mrs. Anne COSPIN | | Applicant Contact Email | anne.cospin@sbm-fr.com | # Device Name 21 CFR 807.92(a)(2) | Device Trade Name | PULLUP®; PULLUP® CLIP; BT LOOP®; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; PULLUP® TEX CLIP; RIGIDLOOP™ Suture Loop | | --- | --- | | Common Name | Smooth or threaded metallic bone fixation fastener | | Classification Name | Fastener, Fixation, Nondegradable, Soft Tissue | | Regulation Number | 888.3040 | | Product Code(s) | MBI | # Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | --- | --- | --- | | K202193 | PULLUP® BTB / PULLUP® CLIP / PULLUP® TEX CLIP / BT LO | MBI | | K151004 | PULLUP® | MBI | # Device Description Summary 21 CFR 807.92(a)(4) - PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft. Standard and XL sizes. - BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary splice suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that can be mounted on the GraftTech® preparation station. Standard and XL sizes. - PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device. Standard and XL sizes. - PULLUP® TEX CLIP: Comprises a nonabsorbable braided loop. One size only. Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm. {5} The implants are supplied sterile, individually packaged, ready to use. The PULLUP®, PULLUP® CLIP, BT LOOP® and PULLUP® TEX CLIP devices are also sold under the trade names RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ BTB and RIGIDLOOP™ Suture Loop respectively. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) 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 Transplant. - RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant. ## Indications for Use Comparison 21 CFR 807.92(a)(5) The indications for use are the same as those of the legally marketed devices K202193. ## Technological Comparison 21 CFR 807.92(a)(6) The predicate device and subject device are substantially equivalent in terms of intended use, material, design, mechanical properties and function. Minor differences do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) - Ultimate failure load (post-fatigue tensile strength) and fatigue displacement met the acceptance criteria established by the predicate device (K202193). - Biocompatibility testing per ISO 10993-1:2018 demonstrated passing results. - Bacterial endotoxin testing was completed and met acceptable limits per ISO 11737-3 (2023) - The devices have a five (5) year shelf-life. Storage and stability is based on completed packaging material storage stability testing, device storage stability testing, and distribution testing. Packaging testing per ISO 11607-1:2019 demonstrated passing results. - Sterile adoption was completed per ISO 11137-1:2006 - MRI safety was evaluated according to ASTM F2503 - 20, IEC 62570:2014 and FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment ## Not Applicable There is no change in material, intended use, indications for use, sterilization method, and shelf-life. Changes in design are minor, and do not raise new or different questions of safety and effectiveness compared with the predicate device. The non-clinical testing has demonstrated that the PULLUP®/BT LOOP®/RIGIDLOOP™ subject devices are substantially equivalent to their PULLUP®/BT LOOP®/RIGIDLOOP™ predicate devices.
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%