(483 days)
SUSTAIN® Spacers: When used as lumbar intervertebral body fusion devices, SUSTAIN® SUSTAIN® R and SUSTAIN® R TPS) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems. When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®. PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. When used as vertebral body replacement devices, SUSTAIN® Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
PATRIOT® Lumbar Spacers: PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental® TPS, TransContinental® M, and TransContinental® M TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (0) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
PATRIOT® Cervical Spacers: PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.
CALIBER® Spacers: CALIBER® Spacers (including CALIBER® TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.
COALITION® Spacers: COALITION® Spacers (including COALITION® TPS) are stand-alone interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. COALITION® Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implants.
INDEPENDENCE® Spacers: INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autogenous bone graft material, and are to be used with three titanium alloy screws, which accompany the implants.
FORTIFY® Corpectomy Spacers: FORTIFY® (including FORTIFY®-R TPS) and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allografi. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
XPand® Corpectomy Spacers: XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
NIKO® Corpectomy Spacers: NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). NIKO® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. These spacers are available in different shapes and heights to accommodate various surqical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). Lumbar spacers may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral lumbar approach. Cervical spacers are inserted using an anterior cervical approach. The SUSTAIN® Spacers are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136, and F1295. SUSTAIN® Radiolucent (SUSTAIN® R) and SUSTAIN® R TPS Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026. SUSTAIN® R TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
PATRIOT® Lumbar Spacers (including Constitution®, Constitution® TPS, Signature®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. Constitution® PLIF Spacers are inserted using a posterior approach. Signature® TLIF Spacers are inserted using a transforaminal approach. Continental® ALIF Spacers are inserted using an anterior approach. Transcontinental® and TransContinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). Signature® R Spacers also include an internal titanium alloy or commercially pure titanium (ASTM F67) component, and TransContinental® M Spacers also include an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295). PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
PATRIOT® Cervical Spacers (including COLONIAL® and COLONIAL® TPS) are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. COLONIAL® ACDF Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
CALIBER® Spacers (including CALIBER® TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER® Spacers provide different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. CALIBER® Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expandable CALIBER® Spacers are manufactured from PEEK only. CALIBER® Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560. CALIBER® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
COALITION®Spacers (including COALITION®TPS) are stand-alone cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. COALITION® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacers are to be filled with autogenous bone graft material. COALITION® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium allov, as specified in ASTM F136 and F1295. COALITION® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacers are to be filled with autogenous bone graft material. INDEPENDENCE® Spacers are made from radiolucent polymer, with titanium allov or tantalum markers, as specified in ASTM F2026. F136. F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. INDEPENDENCE® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
FORTIFY® (including FORTIFY®-R and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY® Integrated endplates have an integrated plate to accommodate screws for additional fixation and are assembled to the core. FORTIFY® and FORTIFY® I-R Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY®-R, FORTIFY®-R TPS, FORTIFY® I-R, and FORTIFY® I-R TPS Corpectomy Spacers are manufactured from radiolucent PEEK polymer, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxyapatite coating per ASTM F1185. FORTIFY® R TPS and FORTIFY® I-R TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The XPand® devices are made from titanium alloy as specified in F136 and F1295. The XPand®-R and XPand®R TPS Corpectomy Spacers are made from radiolucent polymer and titanium alloy as specified in ASTM F2026, F136 and F1295, and include markers made from titanium allov or tantalum as specified in ASTM F136, F1295 and F560. XPand®-R TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights to fit the anatomical needs of a variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. NIKO® Corpectomy Spacers are made from radiolucent polymer and titanium alloy or tantalum as specified in ASTM F2026, F136, F1295, and F560. NIKO® TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.
This document refers to an FDA 510(k) premarket notification for several intervertebral body fusion and corpectomy spacers, all with Titanium Plasma Spray (TPS) coatings. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared devices.
Based on the provided text, the following information can be extracted regarding acceptance criteria and performance studies:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific numerical acceptance criteria. Instead, it states that performance was evaluated in accordance with recognized standards and guidance documents. The reported performance is a general statement of compliance.
| Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|
| Intervertebral Fusion Device Performance: Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007. | "Performance of TPS Spacers was evaluated in accordance with the... guidance." (Implies compliance with the principles outlined in the guidance.) |
| Dynamic Compression Shear and Dynamic Torsion Testing: ASTM F2077 | "Dynamic compression shear and dynamic torsion testing was performed per ASTM F2077." (Implies the testing was conducted and the results were acceptable, though specific values are not provided.) |
| Coating Characterization Testing: Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants, February 2, 2000, and ASTM F1044, F1147, F1160, F1854, and F1978. | "Coating characterization testing was conducted in accordance with the... guidance and ASTM F1044, F1147, F1160, F1854, and F1978, with additional wear analysis to demonstrate adequate coating of the implants." (Implies successful demonstration of adequate coating.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the mechanical or coating tests. These are typically in-vitro (laboratory) tests performed on a representative number of device samples. The data provenance is laboratory testing, not human subject data, so country of origin, retrospective/prospective, etc., are not applicable in the way they would be for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a submission for a medical device (surgical implant), not an AI/diagnostic device that relies on expert interpretation of data. Therefore, the concept of "ground truth established by experts" in this context is not applicable. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ASTM standards and FDA guidance documents.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the studies described are in-vitro mechanical and material characterization tests, not clinical studies requiring adjudication of outcomes or interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This document pertains to physical orthopedic implants, not AI-powered diagnostic or assistive technologies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance data presented is based on established engineering and material science standards (ASTM F2077, F1044, F1147, F1160, F1854, F1978) and FDA guidance documents for mechanical testing and coating characterization of orthopedic implants. It is not derived from biological pathology or clinical outcomes in the same way a diagnostic device would.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical implant.
§ 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.