(60 days)
The Stabilizer Soft Tissue Anchor is intended for use with USP Sutures as an attachment means for soft tissue and bone for the indications listed below: Shoulder (Bankart repair, SLAP lesion repair, Acromioclavicular separation, Rotator cuff repair, Capsule shift \capsulolabral reconstruction, Biceps tenodesis, Deltoid repair), Elbow (Tennis elbow repair, Biceps tendon reattachment, Medial and lateral repairs), Ankle (Lateral instability, Medial instability, Achilles tendon repair/ reconstruction), Knee (Extra-capsular repairs and attachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament and joint capsule to tibia, joint capsule closure to the anterior proximal tibia; Extra-capsular reconstruction, ITB tenodesis; Patellar ligament and tendon avulsions repairs)
The Stabilizer Soft Tissue Anchor is a 316L Stainless Steel implant designed to provide an attachment means for soft tissue to bone using USP grade surgical sutures in joint reconstruction procedures. It is available in two sizes: 5 and 8 mm diameter. Attachment is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and securing soft tissue to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer and to prepare the stabilizer for entry into the predrilled hole.
This document is a 510(k) premarket notification for a medical device, the Stabilizer™ Soft Tissue Anchor. It describes the device, its indications for use, contraindications, and comparisons to a predicate device.
Unfortunately, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about any studies (clinical or non-clinical) that demonstrate the device's performance.
- Sample sizes used for test sets or data provenance.
- Information on experts used for ground truth establishment or adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance.
- The type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
This 510(k) summary is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not on detailing a rigorous performance study with specific acceptance criteria and results. For a device like this (a mechanical anchor), performance data would typically involve biomechanical testing (e.g., pull-out strength, fatigue testing) rather than clinical studies with "ground truth" in the way an AI diagnostic device would. However, even for biomechanical testing, specific acceptance criteria and results would be presented.
§ 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.