(20 days)
The Pore Matrix™ Matrix HA Fusion Porous Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
This device is to be used in patients who have had six weeks of non-operative treatment. The Matrix HA Fusion device is intended to be used with supplemental fixation, such as the Sapphire Medical Group Cervical Plate System. The Matrix HA Fusion device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
The Pore Matrix™ Matrix HA Fusion Porous Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material, intended to stabilize a cervical segment to promote fusion which restricts motion and decreases pain. The Matrix HA Fusion Porous Cervical IBF System is implanted via an Anterior Cervical Discectorny and Fusion (ACDF) surgical approach at one level from C2-T1 and is indicated for use in skeletally mature patients with degenerative disc disease (DDD).
The Matrix HA Fusion Porous Cervical IBF Implants are made from Invibio PEEK-OPTIMA® HA Enhanced and include Pore Matrix Technology. Hydroxyapatite (HA) is fully integrated throughout the porous layers. The Matrix HA Fusion Porous Cervical IBF Implant is made from PEEK which has a modulus of elasticity similar to human vertebral bone. The Porous Layers on the endplate contact surfaces and along the graft window utilize Pore Matrix Technology, a geometry that unlike smooth PEEK, is designed to mimic anatomical cancellous bone, with interconnected spherical pores. The surface to promote cell signaling, on-growth, and fusion. The Matrix HA Fusion Porous Cervical IBF Implant may provide an increased opportunity for bone ingrowth and for achieving early integration. The Matrix HA Fusion Porous Cervical IBF Implant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and is radiolucent allowing assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure. The implants come in 7 heights, 6-12mm in 1mm increments, 8 Footprints with an 8° lordotic angle.
The provided text is a 510(k) summary for the "Matrix HA Fusion Porous Cervical IBF System" and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document states that the device is identical to a predicate device (K220875 Innovasis HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System) in terms of design, materials, manufacturing process, packaging, sizes, and intended use. Therefore, the testing performed on the predicate device is considered fully transferable.
Because this is a substantial equivalence submission, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on providing detailed performance studies against specific acceptance criteria for the new device as if it were a novel technology.
Therefore, I cannot provide the requested information from the given text.
To reiterate, the provided document explicitly states the following:
- "The Pore Matrix™ Matrix HA Fusion Porous Cervical IBF System is identical to the predicate device, K220075 Innovasis HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System."
- "Therefore, the testing that was performed on the Innovasis device is fully transferable to the Pore Matrix device."
This means that no new studies were conducted for the Matrix HA Fusion Porous Cervical IBF System to demonstrate its performance against acceptance criteria. Its performance is inferred to be the same as the predicate device it is "identical" to.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.