(169 days)
The SeaSpine WaveForm™ L System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical, cancellous and/or corticocancellous bone, Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The SeaSpine WaveForm™ L System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm™ L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.
The SeaSpine WaveForm™ L System is intended for use with supplemental fixation.
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation.
The Seaspine WaveForm™ Lumbar Systems are additively manufactured intervertebral fusion devices with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. WaveForm™Lumbar System includes 3 different implants:
- A straight, rectangular-shaped cage, intended for lateral surgical placements, and referred to as WaveForm™ L
- A straight, rectangular-shaped cage, intended for posterior and transforaminal surgical placements, and referred to as WaveForm™ TO, and
- A curved, banana-shaped cage, intended for transforaminal surgical placements, and referred to as WaveForm™ TA, and
The implants are manufactured from Ti-6AI-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in system-specific tray components for storage, protection, and organization prior to and during the steam sterilization process.
This document is a 510(k) Pre-Market Notification from the FDA regarding the SeaSpine WaveForm™ Interbody Systems. It pertains to spinal implants, not an AI/ML medical device. Therefore, the requested information about acceptance criteria for an AI/ML device, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, is not applicable to this document.
The document primarily focuses on:
- Submission Information: Date of submission, contact details, device names (WaveForm™ L, TO, TA Interbody Systems).
- Regulatory Classification: Class II medical device, product codes MAX, PHM, regulation number 21 CFR 888.3080 (Intervertebral Body Fusion Device).
- Predicate Devices: Lists previously cleared devices (K082310, K163230, K181079, K192132) that the new device is compared against for substantial equivalence.
- Device Description: Additively manufactured intervertebral fusion devices made from Ti-6AI-4V ELI titanium alloy, designed with central graft windows for autogenous and/or allogeneic bone graft. Specifies three types (L, TO, TA) for different surgical placements.
- Indications for Use: Details the specific conditions and anatomical locations for which the devices are intended, primarily degenerative disc disease (DDD) and spondylolisthesis in the lumbar and thoracolumbar spine. Emphasizes use as an adjunct to fusion with supplemental fixation and after non-operative treatment.
- Technological Characteristics: States that the devices are identical or similar to predicate devices in components, design, materials, and mechanical performance.
- Non-Clinical Testing: Mentions that mechanical performance equivalence was demonstrated (to the predicate systems) according to ASTM standards F2077, F2267, and F1877.
- Conclusion: The submitted data supports that the SeaSpine WaveForm™ Lumbar Systems perform at least as safely and effectively as the cited legally marketed predicate devices.
Since the request explicitly asks for details related to an AI/ML medical device and a study proving the device meets acceptance criteria, which is not present in this document, I cannot provide the requested information. This document is a clearance for a traditional medical implant, not an AI/ML system.
§ 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.