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The S-Core® Implant System (6.0 mm - 10.0 mm diameter) is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction,

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction,

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair, acetabular labral repair, gluteus medius repair.

The S-Core® Implant System consists of screws and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for the size of device. These large and small bones may include the following:

Fixation of small bone fragments, such as apical fragments (patellar), minimally invasive reconstruction of fractures and joints, adjuvant for osteosynthesis in complex joint fractures, multifragment joint fractures, simple metaphyseal fractures fractures of the wrist, ankle, elbow, and shoulder, condylar fractures, osteochrondritis dissecans, osteochondral fixation, fractures, and fragments (talar, vault, femoral condyle), intra-articular fractures, ligament avulsion injuries, ligament fixation, other small fragments, cancellous bone fragments (talus) or fractures, areas where accurate screw placement is vital, metatarsal and phalangeal osteotomies, fractures of the tarsals, and other fractures of the foot, avulsion fractures of metatarsal V, tarso-metatarsal and metatarso-phalangeal arthrodesis, fractures of small joints, such as: ankle fractures, fractures of the fibula, malleolus, and calcaneus, distal tibia and pilon fractures, acetabular fractures, calcaneal and talar fractures, subtalar arthrodesis, ankle arthrodesis, other fractures of the pelvic ring, fractures of the femoral head and neck, supracondylar femoral fracture, slipped capital femoral epiphyses, an adjunct to DHIS in basilar neck fractures, intercondylar femur fractures, intracapsular fractures of the distal femur and proximal tibia, patellar fractures, tibial plateau fractures, small fragments of the hand wrist, fractures of the carpals and metacarpal arthrodesis, scaphoid fractures of the hand, phalangeal and interphalangeal fractures, fractures of the ulna and radius, radial head fractures of the olecranon and distal humerus, humeral head fractures, ligament fixation at the proximal humerus, glenoid fractures.

The S-Core® Implants are titanium screws that are threaded, headless, cannulated devices offered in diameters ranging from 4mm to 10mm. Each diameter size offers three length options; the shortest being 7mm for the 4mm diameter screw to the longest at 14mm for the 10mm diameter screw. Each screw body incorporates 0.8mm fenestrations on the screw head surface and in a helical pattern within the thread pitch. All screws are offered with the option of an hydroxyapatite (HA) coating. The system also includes stainless steel screw instruments for implantation.

The S-Core® Implant System may be used as a stand-alone screw for the fixation of fracture, fusion, and osteotomies. The S-Core Implant System may also be used with the S-Fibre Suture when used as a suture anchor for the attachment of soft tissue to bone.

The S-Fibre Suture is a non-absorbable, sterile, surgical suture composed of high molecular weight polyethylene (UHMWPE). It is available in white, size 3-0, meeting USP requirements except for oversize diameter. The S-Fibre Suture was originally cleared as the Force Fiber® Polyethylene Non-Absorbable Suture (K063778).

The S-Core® Implant suture anchor includes the S-Fibre Suture (prepackaged) with the titanium screw.

This document is an FDA 510(k) clearance letter for the S-Core® Implant System. It does not describe acceptance criteria for an AI/software device or a study proving an AI/software device meets acceptance criteria. The device is a physical bone fixation fastener (screws and suture anchors) and the testing described is mechanical and biocompatibility testing for this physical device.

Therefore, I cannot extract the information requested about acceptance criteria and a study proving an AI/software device meets the acceptance criteria from the provided text.

The closest relevant sections in the document are:

• Summary of Non-Clinical Performance Testing Bench Test: This section mentions mechanical testing (Torsional Properties, Insertion and Removal Torque, Pullout Strength, Fatigue testing) and bacterial endotoxin testing performed on the physical implant system. These are acceptance criteria for a physical medical device, not for an AI/software.
• Statement of Equivalence: This section states that the device is substantially equivalent to predicate devices based on indications for use and technological characteristics, and that "The submitted test data demonstrates that the proposed device is substantially equivalent to the predicates." This refers to the mechanical and biocompatibility testing mentioned, not an AI performance study.

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