(172 days)
The Invictus Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.
Invictus Core and Invictus SI.Core Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a non-cervical posterior or anterolateral surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.
Invictus Bone Cement is a self-hardening and ready to use polymethylmethacrylate (PMMA) bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. The cement is made of two sterile components: the polymer in powder and the liquid monomer. The liquid component is mainly composed of methacrylate. The major powder components are polymethylmethacrylate, methyl methacrylate, and zirconium dioxide. Benzoyl peroxide, which initiates polymerization, is included in the polymer powder. The powder and liquid monomer are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
The purpose of this submission is to expand indications for use of Invictus fenestrated screws with Invictus Bone Cement, add new fixed fenestrated pedicle screws to the Invictus Spinal Fixation System, and to expand indications of the Invictus Spinal Fixation System for non-cervical anterolateral fixation.
The provided text is a 510(k) summary for a medical device (Invictus® Bone Cement, Invictus Spinal Fixation System). It focuses on establishing substantial equivalence to legally marketed predicate devices based on non-clinical performance data.
Crucially, this document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
Therefore, the information required to answer your request regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth types for test/training sets, training set size, and ground truth establishment for training set) is not present in the provided text.
The document indicates that substantial equivalence was determined through nonclinical testing, specifically:
- Axial Pullout Strength testing per ASTM F543
- Screw Torque Removal testing per ASTM F543
- Cadaveric testing to evaluate cement flow and bolus formation
These tests are typically related to the mechanical and physical performance of the device rather than diagnostic or prognostic accuracy requirements that would necessitate human expert input and clinical study designs.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”