(84 days)
Not Found
Not Found
No
The summary describes a system for soft tissue to bone fixation and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is intended for soft tissue to bone fixation for orthopedic repair and reconstruction procedures, which are therapeutic interventions.
No
The device description focuses on its use for soft tissue to bone fixation and reconstruction procedures, indicating it is an orthopedic implant/surgical tool, not for diagnosing conditions.
No
The device description is not provided, but the intended use clearly describes a system for "soft tissue to bone fixation" and "fixation of tendons and ligaments during orthopedic reconstruction procedures." This strongly implies a physical implant or device, not a software-only solution. The performance studies also mention "biologic endotoxin levels," which is relevant to physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "soft tissue to bone fixation" and "fixation of tendons and ligaments during orthopedic reconstruction procedures." These are surgical procedures performed directly on the patient's body.
- Anatomical Site: The listed anatomical sites (Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist) are all parts of the human body where surgical procedures are performed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention and fixation within the body.
N/A
Intended Use / Indications for Use
The ToggleLoc System devices, except the ToggleLoc XL device, are intended for soft tissue to bone fixation for the following indications:
- Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis
- Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc with Tophat/ZipTight Fixation Devices)
- Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment
- Knee ACL/PCL repair / reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
- Hand and Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
The ToggleLoc XL device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction, as well as fixation in cases of unanticipated intraoperative complications, such as cortical breaching.
Product codes
MBI, JDR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 evaluation demonstrated that the performance of the proposed devices is substantially equivalent to the predicate device in terms of safety and efficacy. Pyrogenicity testing was conducted per ANSI/AAMI/ST72:2011. The results indicate that the biologic endotoxin levels on the ToggleLoc XL devices do not exceed the biologic entodoxin limits stated in ANSI/AAMI/ST72. Clinical data was not required to establish substantial equivalence between the subject ToggleLoc System and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
January 5, 2018
Biomet Inc. Kyle Ponce Regulatory Affairs Associate 56 East Bell Drive Warsaw, Indiana 46581
Re: K173278
Trade/Device Name: ToggleLoc System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, JDR Dated: October 9, 2017 Received: October 13, 2017
Dear Kyle Ponce:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Katherine D. Kavlock -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K173278
Device Name ToggleLoc System
Indications for Use (Describe)
The ToggleLoc System devices, except the ToggleLoc XL device, are intended for soft tissue to bone fixation for the following indications:
- Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis
Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc with Tophat/ZipTight Fixation Devices)
Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment
Knee ACL/PCL repair / reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Hand and Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
3
The ToggleLoc XL device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction, as well as fixation in cases of unanticipated intraoperative complications, such as cortical breaching.
| 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
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ToggleLoc XL 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| 510(k) Number: | K173278 |
|---|---|
| Sponsor: | Biomet Inc. |
| 56 East Bell Drive | |
| PO Box 587 | |
| Warsaw, IN 46581 | |
| Establishment Registration Number: 1825034 | |
| Contact Person: | Kyle Ponce |
| Regulatory Affairs Associate | |
| Telephone: (973)-299-9300 Ext 2125 | |
| Fax: (574)-372-1718 | |
| Date: | October 9, 2017 |
| Subject Device: | Trade Name: ToggleLoc System |
| Common Name: Soft Tissue Fixation Devices | |
| Classification Name: | • MBI – Fastener, Fixation, Non-Degradable, Soft Tissue |
| (21 CFR 888.3040) | |
| • JDR – Staple, Fixation, Bone (21 CFR 888.3030) | |
| Predicate Device(s): |
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Shoulder
Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc with Tophat/ZipTight Fixation Devices)
Elbow
Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment
Knee
ACL/PCL repair / reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
Hand and Wrist
Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
The ToggleLoc XL device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction, as well as fixation in cases
6
Summary of Technological Characteristics:
of unanticipated intraoperative complications, such as cortical breaching.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Intended use is identical to the predicate devices.
- Indications for Use: Indications are similar to the . predicate devices. This submission is expanding indications for the ToggleLoc XL.
- Materials: Materials are identical to the predicate ● devices.
- Design Features: Design features are identical to the predicate devices.
- Sterilization: The proposed ToggleLoc System ● devices are provided sterile via EtO. the same sterilization method utilized for the predicate devices.
Summary of Performance Data (Nonclinical and/or Clinical)
● Non-Clinical Tests:
- Non-clinical evaluation demonstrated that the o performance of the proposed devices is substantially equivalent to the predicate device in terms of safety and efficacy.
- Pyrogenicity testing was conducted per O ANSI/AAMI/ST72:2011. The results indicate that the biologic endotoxin levels on the ToggleLoc XL devices do not exceed the biologic entodoxin limits stated in ANSI/AAMI/ST72.
- . Clinical Tests:
- Clinical data was not required to establish o substantial equivalence between the subject ToggleLoc System and the predicate devices.
The proposed ToggleLoc System has similar intended use, technological characteristics, and mechanical performance as the predicate devices. The performance engineering analysis identified no new risks and substantial equivalence to the legally marketed predicate devices.
Substantial Equivalence Conclusion