(72 days)
No
The device description and performance studies focus on mechanical and biological properties of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is designed for ACL reconstruction to provide cortical fixation, which is a therapeutic intervention aimed at repairing or restoring the function of the damaged ACL.
No
Explanation: The device is described as a "cortical fixation for ACL reconstruction," which is a surgical implant designed for repair, not diagnosis. It does not mention any function for detecting, measuring, or analyzing medical conditions.
No
The device description clearly outlines physical components made of titanium and braided loops, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that these devices are implants designed for cortical fixation for ACL reconstruction. They are physical devices implanted into the body to stabilize a ligament.
- Intended Use: The intended use is for a surgical procedure (ACL reconstruction), not for analyzing biological samples.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The PULLUP® BTB, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The device is proposed in the following variants:
- -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.
- PULLUP® BTB: 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.
- -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 must be mounted on the GraftTech® preparation station.
- -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 PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device.
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.
The implants are supplied sterile, individually packaged, ready to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing included biocompatibility, biological, and mechanical performances. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices. The proposed device has been determined to be non-pyrogenic. Clinical performance data was not included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
October 16, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
S.B.M. SAS (Science & Bio Materials) Anne Cospin-Latapie Quality/Regulatory Affairs Manager Zi Du Monge Lourdes, 65100 France
Re: K202193
Trade/Device Name: 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 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 30, 2020 Received: August 5, 2020
Dear Anne Cospin-Latapie:
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 (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 located 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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FORM 3881
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202193
Device Name
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 and BT LOOP® Adjustable fixation system for ligament reconstruction.
Indications for Use (Describe)
The PULLUP® BTB, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP devices are designed to be used as cortical fixation for ACL reconstruction.
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)
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510(k) SUMMARY
1. SUBMITTER
S.B.M. SAS
SCIENCE & BIO MATERIALS
ZI du Monge
F 65100 LOURDES – FRANCE
Registration Number: 3004549189
Phone: +33 (0)5 62 42 21 01
Fax: +33 (0)5 62 42 21 00
Contact Person: Anne COSPIN-LATAPIE
e-mail : anne.cospin@sbm-fr.com
Date prepared: 03 July 2020
2. DEVICE
| Name of Device | PULLUP® BTB, BT LOOP®, PULLUP® CLIP &
PULLUP® TEX CLIP |
|----------------------|-----------------------------------------------------------|
| Common or Usual Name | Adjustable Fixation System for Ligament Reconstruction |
| Classification Name | Fastener, fixation, nondegradable, soft tissue |
| Regulatory Class | II |
| Product Code | MBI |
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3. PREDICATE DEVICE
K151004 - PULLUP® Adjustable Juxtacortical Fixation Device
Referenced devices :
K092533 - FORCE FIBER® BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
K930739 - DEKNATEL® SUTURES POLYPROP., POLYETHELINE (sic), NYLON & SILK
4. DEVICE DESCRIPTION
The device is proposed in the following variants:
- -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.
- PULLUP® BTB: 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.
- -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 must be mounted on the GraftTech® preparation station.
- -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 PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device.
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.
The implants are supplied sterile, individually packaged, ready to use.
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5. 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.
6. PERFORMANCE DATA
Non-clinical performance testing
Non-clinical testing including biocompatibility, biological and mechanical performances were not impacted by the change. The results indicated that the devices were functional within their intended use and equivalent to the predicate devices.
The proposed device has been determined to be non-pyrogenic.
Clinical performance testing:
Clinical performance data was not included.
7. SUBSTANTIAL EQUIVALENCE
The modifications to the PULLUP® Adjustable cortical fixation device (K151004) consist in the addition of new variants for ACL reconstruction: two systems for ACL reconstruction with a bone-tendon-bone graft, one of which must be used with SBM's GraftTech® preparation station, and a system for ACL reconstruction with a connectable button-plate that can be attached to other PULLUP® systems.
The added systems are substantially equivalent to their predicate device PULLUP® (K151004) in terms of intended use, material, design, mechanical properties and function.