(177 days)
The F3D Lateral Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). F3D Lateral Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the Oro Lateral plate for fixation. If using the 1-hole CoreLink Oro Lateral Plate System, additional supplemental fixation is required (e.g. posterior fixation).
The CL5 Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). CL5 Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The CoreLink Oro Lateral Plate System (LPS), in two and four-hole configurations, is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink Oro Lateral Plate System is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
Alternatively, the CoreLink Oro Lateral Plate System may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink Oro LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
The CoreLink Oro LPS, one-hole configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The one-hole plate is not intended for use in load-bearing applications.
Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the CoreLink Oro Lateral Plate System (LPS) for fixation.
The F3D Lateral Lumbar Interbody System, additively manufactured Ti-6A1-4V ELI per ASTM F3001 implants, and the CL5 Lateral Lumbar Interbody System, PEEK implants per ASTM F2026 with Tantalum per ASTM F560, are lumbar interbody spacers designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lateral lumbar spacers with hollow footprints for placement of graft material feature a wide variety of footprint, height, and lordosis options to accommodate patient anatomical needs. The F3D spacers are designed with a porous surface to optimize bone in-growth. The CL5 spacers are designed with ridges on the superior and inferior surfaces to improve grip against the end-plates and prevent expulsion. The Oro Lateral Plate System consists of plates and screws intended for use as a laterally placed supplemental fixation device via the lateral or anterior lateral surgical approach above the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Oro Plate System implants are manufactured from Ti-6AI-4V ELI per ASTM F136 with Nitinol springs per ASTM F2063 in the plate's screw anti-backout plates. The plates are offered in 1-Screw, or 4-Screw configurations and in multiple lengths for single level fixation. The 1-Screw plate configuration is designed to maintain the relative position of interbody spacers during spinal fusion and is non-load bearing. The 2-Screw and 4-Screw plate configurations are designed as supplemental fixation for lumbar fusion. The plate screws are available in a variety of size options.
All Oro plates may be permanently attached to the F3D or CL5 spacers and assume the indications for use of the spacers.
The spacer and plate systems have been previously cleared (K183239, K150847, and K190016). This 510(K) submission offers additional implants to the previously cleared sets.
The provided text describes medical devices (spinal implants) and their indications for use, characteristics, and comparison to predicate devices for FDA clearance. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or MRMC studies.
The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for diagnostic AI/software.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them because this type of information is not present in the provided text. The document primarily discusses mechanical testing results to demonstrate that the strength of the devices is "sufficient for their intended use and are substantially equivalent to legally marketed predicate devices."
The requested information points cannot be extracted from the given text as it pertains to AI/software performance validation, while the document describes physical medical devices and their mechanical testing.
§ 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.