(83 days)
Indications for the G-FORCE™ Tenodesis Screw include use in soft tissue reattachment procedures in the shoulder, foot/ankle, knee, elbow and wrist/hand where the sizes offered are patient appropriate. Specific indications include the following:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsule Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Wrist/Hand: Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty, Carpal Ligament Repair/Reconstruction and tendon transfers in the wrist and hand.
The design features of the G-FORCE™ Tenodesis Screw are described below.
- Generous thread radii to minimize soft tissue damage
- Manufactured from PEEK-Optima .
- Radiolucent
- Screws are available in five diameters and four lengths
The design features of the G-FORCE™ Tenodesis Screw are substantially equivalent to the design features of other devices previously cleared for market.
The provided text is a 510(k) summary for the G-Force™ Tenodesis Screw. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is primarily for demonstrating substantial equivalence to a previously cleared predicate device, not for proving individual performance against specific acceptance criteria through a dedicated study.
Therefore, I cannot provide the requested information from the given text. The document focuses on:
- Intended Use and Indications: Describing what the device is for and where it can be used.
- Device Description: Highlighting design features and material.
- Substantial Equivalence Information: Stating that the device is substantially equivalent to predicate devices based on design, material, and indications for use. This is the core of a 510(k) submission.
- FDA Review and Clearance Letter: Confirming the FDA's determination of substantial equivalence.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.