(125 days)
The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment.
The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
The Ardis® Interbody System is a device for interbody fusion of the anterior column of the spine. The Ardis implant may be used to replace the disc. These cages are hollow so that bone can grow through the device. fusing the adjacent bony surfaces.
The Ardis implant is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths and heights. Zimmer Spine designed Ardis to be placed through a posterior or transforaminal approach and to address vertebrae in the lumbosacral region of the spine. The system contains implants of various sizes to accommodate different patient anatomy. and instruments for site preparation. trialing and insertion. The device is crafted from (polvetheretherketone) PEEK-OPTIMA (ASTM F2026). As PEEK-OPTIMA is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires and beads (ASTM F560) that are press fit into small holes in the implant. Additionally. the Zimmer Spine Ardis® Interbody System includes the instrumentation to facilitate the implantation of the system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel. and/or polvmeric materials.
The Ardis Inserter that is the subject of this premarket notification is an instrument intended for use with the Ardis® Interbody System. The instrument is designed specifically to implant the PEEK interbody device into a prepared disc space. The inserter threads into the posterior hole of the PEEK implant securing the implant in place with a secondary locking (anti-rotation) mechanism. The inserter design is specific to the width measurement of the PEEK implant. A 9mm width implant will be used in conjunction with the PEEK Ardis Inserter, 9mm, and an 1 Imm implant will be inserted using the PEEK Ardis Inserter, 1 I mm.
The provided text describes a 510(k) summary for the Zimmer Spine Ardis® Interbody System and Ardis Inserter. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.
The document discusses:
- The device description (spinal intervertebral body fusion device and its inserter).
- Its classification (Class II, Spinal Intervertebral Body Fusion Device).
- The predicate device (Zimmer Spine Ardis® Spacer System, K073202).
- Indications for Use.
- Technological characteristics and comparison to the predicate device (stating substantial equivalence).
- Performance Data: It briefly mentions "Design Verification Testing and Design Validation studies conducted on the Ardis Interbody System implants and instruments demonstrated the performance of the subject device was substantially equivalent in design, function, material, biocompatibility and sterilization when compared to the predicate device."
- Substantial Equivalence: It reiterates that documentation was submitted to demonstrate substantial equivalence, and that the design modification (the inserter itself) does not present new issues of safety or effectiveness.
Based on the provided text, none of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML-enabled medical device is available.
This document is a traditional 510(k) submission for a physical medical device (an intervertebral body fusion device and its inserter), focusing on demonstrating substantial equivalence to a predicate device through engineering design verification and validation, material testing, biocompatibility, and sterilization, rather than AI/ML performance metrics.
§ 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.