(120 days)
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTiC-L™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTIC-XL™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
The ARTIC-L™ and ARTIC-XL™ 3D Ti Spinal Systems with TiONIC™ Technology consist of additively manufactured (AM) titanium spacers of various widths, lengths, heights and lordotic angles and reusable instruments used for implantation and extraction of the subject implant. The instruments may be transported to the customer in cases, trays and lids which can also be used for sterilization. These implants are intended to be surgically placed between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion surgical procedures.
This document describes the regulatory submission for the Medtronic ARTiC-L™ 3D Ti Spinal System and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance, biocompatibility, and MRI safety. The document doesn't present a table with explicit numerical acceptance criteria values alongside reported device performance. Instead, it states that the tests were performed "in accordance with" relevant ASTM standards and guidance documents, implying that the acceptance criteria are adherence to these established standards and comparable performance to predicates.
The reported device performance is presented as:
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Adherence to "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" (FDA Guidance, June 16, 2016). | - Evaluated for permanent, >30-day body contact for implants. |
- Materials: Titanium-6 Aluminum-4 Vanadium ELI.
- Tests performed: Chemical Characterization, Toxicological Risk Assessment, Cytotoxicity, Acute Systemic Toxicity, Material Mediated Pyrogenicity.
- Results: "Based on the results, no additional testing was required." (Implies successful completion and adherence to safety profiles).
- Bacterial Endotoxin (LAL) test: Successfully met 20 EU/device pyrogen limit specification (as per ANSI/AAMI ST72 and USP ).
- Instruments (non-sterile, external communicating for
§ 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.