(57 days)
Reef L Interbody System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The Reef L Interbody System with NanoMetalene® surface technology 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). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The Reef L Interbody 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 contiguous 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 Reef L Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Reef L Interbody System is intended for use with supplemental fixation. Hyperlordotic sizes (greater than 200) must be used with legally marketed anterior supplemental fixation.
TruProfile Interbody Implants (i.e., interbody implants used with TruProfile Plates):
The Reef L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 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 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft, allogeneic bone graft composed of cancellous, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion. The Reef L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Reef L Interbody System assembled with the 1-Hole TruProfile Lateral Plate, when used with a single Screw, is intended for use with additional legally marketed anterior or posterior supplemental fixation.
WaveForm L Interbody System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The WaveForm L Interbody 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). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The WaveForm L Interbody 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 degenerative spondylolisthesis at one or two contiguous 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 WaveForm L Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The WaveForm L Interbody System is intended for use with supplemental fixation. Hyperlordotic sizes (greater than 20°) must be used with legally marketed anterior supplemental fixation.
TruProfile Interbody Implants (i.e., interbody implants used with TruProfile Plates):
The WaveForm L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 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 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, can adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The WaveForm L Interbody System assembled with the 1-Hole TruProfile Lateral Plate, when used with a single Screw, is intended for use with additional legally marketed anterior or posterior supplemental fixation.
Reef L Interbody System
The Reef L Interbody System featuring NanoMetalene surface technology consists of lateral intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include central graft windows for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized.
The Reef L interbody spacers can be used alone with supplemental fixation or in combination with fixation implants (i.e., plates, screws, and locking covers) to create the TruProfile Interbody configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
WaveForm L Interbody System
The WaveForm L Interbody System consists of lateral intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized.
The WaveForm L interbody spacers can be used alone with supplemental fixation or in combination with fixation implants (i.e., plates, screws, and locking covers) to create the TruProfile Interbody configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
This document is a 510(k) summary for the Reef L Interbody System and WaveForm L Interbody System. It describes the devices' characteristics and claims substantial equivalence to predicate devices through non-clinical testing.
Based on the provided text, the following information can be extracted regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | Substantially equivalent to predicate systems through static and dynamic axial compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), wear evaluation (ASTM F2077), and expulsion. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the test set used in non-clinical mechanical testing.
- The data provenance is from non-clinical testing (mechanical performance). The document does not specify country of origin or whether it's retrospective or prospective, though non-clinical tests are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the evaluation was based on non-clinical mechanical testing, not expert-derived ground truth on clinical data.
4. Adjudication method for the test set:
- This information is not applicable as the evaluation was based on non-clinical mechanical testing, not clinical data requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The "Clinical Testing" section explicitly states: "Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This device is a physical intervertebral body fusion system, not an algorithm or software. Its performance is evaluated through physical and mechanical tests.
7. The type of ground truth used:
- For the non-clinical testing, the "ground truth" implicitly refers to the specified performance standards and mechanical properties outlined in standard test methods (ASTM F2077, ASTM F2267) and compared against predicate devices. The goal was to demonstrate substantial equivalence, not to establish a "ground truth" in the clinical sense.
8. The sample size for the training set:
- This information is not applicable as there is no mention of a training set. The evaluation is based on non-clinical mechanical testing, not machine learning or AI.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no mention of a training set or a ground truth established for one.
§ 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.