(84 days)
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.
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This section focuses on the regulatory information for the ToggleLoc System, specifically its 510(k) premarket notification. The provided text, however, does not contain any information regarding acceptance criteria, study details, or performance data in the context of device approval. It primarily establishes the legal basis for marketing the ToggleLoc System as substantially equivalent to previously approved devices.
Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided input. The document explicitly states:
- "Summary of Performance Data (Nonclinical and/or Clinical) ... Clinical data was not required to establish substantial equivalence between the subject ToggleLoc System and the predicate devices."
- "Non-clinical evaluation demonstrated that the performance of the proposed devices is substantially equivalent to the predicate device in terms of safety and efficacy."
This indicates that the approval was based on demonstrating substantial equivalence through non-clinical evaluation and comparisons of intended use, indications, materials, design features, and sterilization methods to predicate devices, rather than a specific study with defined acceptance criteria and performance outcomes.
If this were a document about a de novo device or a device requiring clinical trials, such information would typically be present.
§ 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.