(114 days)
The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Implants are used to facilitate fusion in the lumbar spine using autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.
The restor3d TiDAL Lumbar Interbody Fusion System are additively manufactured Titanium Alloy (Ti-6AL-4V per ASTM F2924) implants, designed for use as a lumbar interbody fusion device. They are provided sterile-packed. The system is comprised of various sizes to accommodate individual patient anatomy as well as multiple designs to support several surgical techniques (PLIF, ALIF, OLIF, LLIF). Each approach includes several offerings that vary by footprint (width and depth/length), height, and lordotic angle. All sizes have a large central window(s) for packing autogenous bone graft and/or allogenic bone graft. The inferior and superior faces have endplate surface lattices as well as teeth to resist migration when placed in between the vertebral bodies.
The provided text is a 510(k) premarket notification for a medical device called the "restor3d TiDAL Lumbar Interbody Fusion Device." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt.
Therefore, the document does not contain the information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
Instead, the document details:
- Device Name: restor3d TiDAL Lumbar Interbody Fusion Device
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral Body Fusion Device
- Regulatory Class: Class II
- Product Code: MAX
- Indications for Use: Used as an intervertebral body fusion device with bone graft in lumbar spine for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, possibly with up to grade 1 spondylolisthesis or retrolisthesis. Patients must have undergone at least six months of non-operative treatment and the device is intended for use with supplemental fixation systems cleared for the lumbar spine.
- Predicate Devices:
- Device Description: Additively manufactured Titanium Alloy (Ti-6AL-4V per ASTM F2924) implants, provided sterile-packed, with various sizes and designs for different surgical techniques (PLIF, ALIF, OLIF, LLIF). They include large central windows for bone graft and endplate surface lattices/teeth to resist migration.
- Technological Characteristics: Claims substantial equivalence to predicate devices in design, intended use, implant materials, product features, mechanical performance, and function.
- Performance Testing: Mechanical performance testing was performed through compression and compression-shear (ASTM F2077), subsidence testing (ASTM F2267), and expulsion testing. The document states that the device demonstrated mechanical performance equivalence to the predicate devices.
Conclusion stated in the document: The restor3d TiDAL Lumbar Interbody Fusion System was shown to be substantially equivalent in performance and technological characteristics to its predicate devices and does not raise new questions about safety or effectiveness.
§ 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.