(90 days)
The Stryker Spine Tritanium® PL Cage 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 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 at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® PL Cage is to be implanted via a posterior approach.
The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The purpose of this submission is to introduce new implant sizes to the previously cleared Tritanium® PL Cage offering. The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that 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 cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine. The Tritanium® PL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.
This document is a 510(k) premarket notification for a medical device, the Stryker Spine Tritanium® PL Cage. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in the form of numerical thresholds for performance. Instead, the "acceptance criteria" are implied by the requirement to demonstrate "substantially equivalent performance" to predicate devices through various mechanical tests. The reported device performance is that it met the requirements of these tests.
Acceptance Criterion (Implied) Reported Device Performance Substantially equivalent performance to predicate devices (K160955, K151726) per FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". Testing performed on the subject Tritanium® PL Cages demonstrated substantially equivalent performance to the identified predicate devices in compliance with the FDA guidance document. Static and Dynamic Compression (per ASTM F2077) Performed Static and Dynamic Compression Shear (per ASTM F2077) Performed Static and Dynamic Torsion (per ASTM F2077) Performed Expulsion (per ASTM F04-25-02-02 Draft) Performed Subsidence (per ASTM F2267) Performed Wear Debris Assessment Performed Impaction Performed 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.