(107 days)
The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.
DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.
The Tritanium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
The Stryker Spine Tritanium® C Anterior Cervical Cage is a hollow, ring shaped titanium alloy (Ti-6Al-4V) interbody fusion cage intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Tritanium® C Anterior Cervical Cage consists 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 Tritanium® C Anterior Cervical Cage is provided sterile.
This document is a 510(k) summary for the Stryker Spine Tritanium® C Anterior Cervical Cage, an intervertebral body fusion device. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Standard/Guidance Referenced) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Based on FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" and specific ASTM standards: | "demonstrated substantially equivalent performance to the identified predicate devices." Specific tests performed include: |
- Static Compression (per ASTM F2077)
- Dynamic Compression (per ASTM F2077)
- Static Compression Shear (per ASTM F2077)
- Dynamic Compression Shear (per ASTM F2077)
- Static Torsion (per ASTM F2077)
- Dynamic Torsion (per ASTM F2077)
- Expulsion (per ASTM F04-25-02-02 Draft)
- Subsidence (per ASTM F2267)
- Wear Debris Assessment
- Impaction |
| Material Properties | FDA guidance documents: - "Guidance Document for testing orthopedic implants with modified metallic surfaces apposing bone or bone cement [April 28, 1994]"
- "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses [January 16, 2003]"
- Draft guidance for "Technical considerations for Additive Manufactured Devices [May 10, 2016]"
ASTM Standard: - ASTM 1472-08: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical Implant Applications | "established that the porous surface design of the cage meets at minimum the requirements outlined in the [referenced FDA guidance documents and ASTM standard]." |
| Material Mechanical Properties | ASTM standards: - ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate and Metallic Coatings
- ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coating
- ASTM E8/E8M: Standard Test Methods for Tension Testing of Metallic Materials | Characterization of the Mechanical Properties of the Tritanium® C Anterior Cervical Cage material was performed in accordance with these standards. The conclusion states "results of the mechanical testing... demonstrated substantial equivalence." |
| Corrosion Susceptibility | ASTM F2129-15: Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices. | "Electromechanical performance evaluation of additive manufactured Ti-6Al-4V alloy was also performed per ASTM F2129-15." The overall conclusion implies satisfactory performance. |
| Pyrogenicity | ANSI/AAMI ST72:2011: For bacterial endotoxin testing (BET) to achieve an endotoxin limit of
§ 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.