(303 days)
The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular repair, acetabular labral repair.
The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.
Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".
The Suture Anchors - GM Reis is composed of two different groups of anchors:
- HTA – Headless Titanium Anchor.
- Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
- -ZIP Anchor.
- Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.
This document is a 510(k) Premarket Notification from the FDA regarding "Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors." It details the device, its intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria for an AI/algorithmic device.
The document discusses non-clinical performance data for the suture anchors themselves (insertion torque, pullout strength, MRI compatibility) to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-driven diagnostic or therapeutic tool.
Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about a study proving an AI/algorithmic device meets acceptance criteria, which is not what this FDA document is about.
§ 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.