(58 days)
When used as a vertebral body replacement:
The ChoiceSpine Octane-A/T/P Spinal Implant is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Octane device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation to facilitate fusion.
When used as an intervertebral body fusion device:
The Octane-A/T/P Spinal Implant is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD), with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The Ascendant PC Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ascendant PC Cervical Spacer System is to be used autogenous and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The Ascendant Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one-disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment.The Ascendant Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The BLACKHAWK™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The BLACKHAWK™ Cervical Spacer System is to be used autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plated via an open, anterior approach.
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The Octane Straight PC Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
The VEO™ Lateral Access & Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and supplemental spinal fixation that is cleared for use in the lumbar spine.
This submission includes 7 subject devices. The device descriptions for each are listed below:
The ChoiceSpine Octane Straight Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The Octane Straight Intervertebral Fusion Device is provided sterile for single use.
The ChoiceSpine Octane Straight PC Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The device is plasma coated with commercial pure titanium (CPTi) per ASTM F1580. The Octane Straight PC Intervertebral Fusion Device is provided sterile for single use.
The BLACKHAWK™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK implant cage per ASTM F2026 with tantalum radiographic markers per ASTM F560, nitinol internal locking components per ASTM F2063 and two internal titanium alloy anchors (Ti-6Al-4V ELI) per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices feature a chamber intended to be filled with autogenous bone and or/allogenic bone graft material. They are used with two internal anchors that lock on deployment and provide additional fixation. The BLACKHAWK™ Cervical Spacer System is to be used with autogenous bone and or/allogenic bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
The Ascendant® Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material. The Ascendant® Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).
The Ascendant™ PC Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material.
The VEO® Lateral Access & Interbody Fusion System is a multi-component system including instrumentation made of biocompatible materials such as Stainless Steel, Aluminum, and Radel R and implants made of Tantalum (ASTM F560) and PEEK (ASTM F2026) or Ti-6AI-4V ELI (ASTM F136).
The ChoiceSpine Octane®-A/T/P Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plain to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The ChoiceSpine Octane Spinal Implant is provided sterile in three (3) styles:
. The Octane-T Spinal Implant, available heights of 7mm to 17mm, in 2mm increments;
. The Octane-P Spinal Implant, available in heights of 7mm to 17mm, in 2mm increments; and
. The Octane-A Spinal Implant, available in heights of 9mm to 19mm, in 2mm increments, and with a convex superior and inferior surface, angled at either 6° or 12° and in Small, Medium, or Large transverse profile.
This FDA 510(k) summary does not contain information regarding the acceptance criteria or a study proving the device meets acceptance criteria. The document is a premarket notification for multiple spinal implant systems seeking clearance for a change in indications for use, specifically to allow the use of autogenous bone and/or allogenic bone graft.
As such, the information typically found in an acceptance criteria and study report for a new medical device (such as those involving performance metrics, clinical trials, sample sizes, expert adjudication, or AI analysis) is not present here.
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their devices are as safe and effective as existing, legally marketed devices, rather than introducing a novel technology that requires extensive new performance data.
Here's a breakdown of why the requested information is absent and what is covered:
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A table of acceptance criteria and the reported device performance: Not provided. Substantial equivalence is based on comparing the subject device to predicates, not against specific performance criteria in a new study.
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Sample sized used for the test set and the data provenance: Not applicable. There is no new test set/clinical study described. The submission relies on the existing safety and effectiveness established for the predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment is described.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is more common for diagnostic imaging AI devices, not for spinal implants demonstrating substantial equivalence for a change in bone graft material.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
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The type of ground truth used: Not applicable.
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The sample size for the training set: Not applicable. There is no AI/algorithm component to train.
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How the ground truth for the training set was established: Not applicable.
What the document does state about "testing" and "equivalence":
- Non-Clinical Testing: "All subject components have been cleared and therefore do not present a new mechanical worst-case and no non-clinical testing is needed." (Page 13) This indicates that previous testing on the components was deemed sufficient for the initial clearances, and the change in indications for use (specifically related to the type of bone graft) doesn't warrant new mechanical testing.
- Substantial Equivalence Conclusion: The document concludes that the subject devices are substantially equivalent to the predicates in various aspects including "principle of operation, materials, indications for use, biocompatibility, manufacturing and post processing steps, stabilization methods, sterilizations method, anatomic location and approach, product classification and product codes." The only noted difference is the specific wording around bone graft material. (Page 14)
In summary, this document is a 510(k) submission for spinal implants relying on substantial equivalence to existing devices for a minor change in intended use regarding bone graft material. It does not describe new performance studies or acceptance criteria in the manner requested.
§ 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.