(60 days)
Monterey™ AL Interbody System - Stand-Alone
The Stryker Spine Monterey™ AL Interbody System - Stand-Alone (AL Stand-Alone) is an interbody fusion device 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 or two contiguous levels from L2-S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.
The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation).
Monterey™ AL Interbody System - Spacer
The Stryker Spine Monterey™ AL Interbody System - Spacer) is an intervertebral body fusion device 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 or two contiguous levels from L2-S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.
Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.
The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.
The purpose of this Traditional 510(k) submission is to introduce the Monterey™ AL Interbody System, a new anterior lumbar interbody fusion device (IBD) product line.
These cages consist of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage has two designs: a stand-alone cage which includes screw holes for integrated fixation, and a spacer for use with external supplemental fixation. The cage is offered in a variety of heights, depths, widths, and lordotic angles to adapt to a variety of patient anatomies. It has biological fixation and to maximize surface area for endplate contact with the implant. The subject cages are wedge-shaped, featuring a tapered posterior edge for ease of pre-positioning and insertion into the disc space. The cages also contain a large central space for graft containment, as well as 2 lateral windows for graft visualization.
The Monterey™ AL cages and screws are manufactured out of Ti6Al4V.
Cages: Ti6Al4V (ASTM F1472, ISO 5832-3, ASTM F136) Screws: Ti6Al4V (ISO 5832-3, ASTM F136)
The provided text describes a medical device, the Monterey™ AL Interbody System, and outlines its indications for use and a summary of performance data. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.
The document is a 510(k) summary for a physical medical device (an intervertebral body fusion device) and focuses on demonstrating substantial equivalence to predicate devices through material, design, and mechanical performance testing.
Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance: No such table or specific acceptance criteria are mentioned for an AI/ML component. The performance data listed (Static and Dynamic Compression, Expulsion, Subsidence, etc.) are for the physical interbody device.
- Sample size used for the test set and the data provenance: Not applicable as no AI/ML study is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.