(62 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical application, with no mention of AI/ML, image processing, or data analysis.
No.
The device is described as being for "soft tissue to bone fixation" for various repairs and reconstructions, functioning as an implant. It is not described as providing therapy or treatment in itself, but rather as an aid in surgical repair.
No
The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for various orthopedic repairs and reconstructions. Its description as toggle buttons and a Tophat suture button preloaded with sutures indicates it is a surgical implant for repair, not a device used for diagnosis.
No
The device description explicitly states that the ToggleLoc™ System contains "toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs," which are physical hardware components.
Based on the provided information, the ToggleLoc™ System Devices are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "soft tissue to bone fixation" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as containing "toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs." This is a physical implant used during surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are non-clinical laboratory testing to determine functionality, which is typical for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ToggleLoc™ System is a surgical tool/implant used for repair and reconstruction, not for diagnosis.
N/A
Intended Use / Indications for Use
The ToggleLoc™ System Devices 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)
Elbow; Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCLrepair / 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 dosure
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair
Product codes (comma separated list FDA assigned to the subject device)
MBI, JDR
Device Description
The ToggleLoc™ System contains toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs. The suture button has multiple eyelets for attachment of fiber constructs and/or sutures. The fiber constructs and/or sutures are preloaded for the convenience of the surgeon for soft tissue attachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip
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 Testing: Non-dinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
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.
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/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and connected to each other. There is a registered trademark symbol to the right of the letter "T". The word is in black and the background is white.
510(k) Summary
DEC 1 6 2008
Preparation Date: December 4, 2008
Applicant/Sponsor: Biomet Sports Medicine
Contact Person: Robert Friddle
Proprietary Name: ToggleLoc™ System
Common Name: Soft tissue anchor
Classification Name: Fastener, fixation, nondegradable, soft tissue (888.3040)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
TightRope™ Syndesmosis Device - K043248 (Arthrex) Sleeve and Button Soft Tissue Devices - K071704 (Biomet Sports Medicine) Titanium Toggle Buttons - K033838 (Biomet Sports Medicine, formerly known as Arthrotek, Inc.)
Device Description: The ToggleLoc™ System contains toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs. The suture button has multiple eyelets for attachment of fiber constructs and/or sutures. The fiber constructs and/or sutures are preloaded for the convenience of the surgeon for soft tissue attachment.
Intended Use: The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repairs Acromio-clavicular repair, Capsular shift/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)
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
Hip: Acetabular labral repair
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800,348,9500 Office: 574.267.6539 Main Fax: 574.372.1718 www.blomet.com
Shipping Address: 56 East Bell Drive Warsaw. IN 46582
1
Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the ToggleLoc™ System devices are similar or identical to the predicate device or other previously cleared devices.
Non-Clinical Testing: Non-dinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. except TightRope™ which is a trademark of Arthrex.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2008
Biomet Sports Medicine % Mr. Robert Friddle 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587
Re: K083070
Trade/Device Name: ToggleLocTM System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, JDR Dated: October 13, 2008 Received: October 15, 2008
Dear Mr. Friddle:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Robert Friddle
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events, (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Milherson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KD83070
Device Name: _ ToggleLoc™ System
Indications for Use:
The ToggleLoc™ System Devices 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)
Elbow; Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCLrepair / 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 dosure
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
Division of General, Restorative, and Neurological Devices
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510(k) Number L083070