(41 days)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
The implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional implant sizes into the system.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
The provided document is a 510(k) summary for the K2M Cascadia Interbody System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies as one might find for a novel drug or a high-risk AI-powered diagnostic.
Therefore, many of the requested fields regarding acceptance criteria, study details, and ground truth establishment are not applicable in the context of this 510(k) submission. The FDA clearance for this device hinges on mechanical testing and comparison to existing devices, not performance against clinical endpoints.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such, but inferred from testing regime) | Reported Device Performance |
|---|---|
| Static Compression: Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Dynamic Compression (ASTM F2077): Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Subsidence (ASTM F2267): Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Expulsion: Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Bacterial Endotoxin Limit (ANSI/AAMI ST72:2011): |
§ 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.