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The ENDOSKELETON® TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device may be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ENDOSKELETON® TA is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TAS Interbody Fusion device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of nonoperative treatment prior to treatment with the device is a standalone system that is intended to be used with the bone screws provided and requres no additional supplementary fixation. The Device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/or demineralized allograft bone with bone marrow aspirate.

Hyperlordotic Devices ≥16°: The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device (≥ 16°) is indicated for use 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 I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/ or demineralized allograft bone with bone marrow aspirate.The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine must be used with a posterior supplemental inxation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The ENDOSKELETON® TC is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and be used with autograft bone and/ or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous bone and/or demineralized allograft bone with bone marrow aspirate. The device is a stand-alone system when used with ENDOSKELETON® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in 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. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation systems that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate.

The ENDOSKELETON® TO Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The ENDOSKELETON® TT Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non- operative treatment prior to treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate.

The current Endoskeleton® System is an interbody and vertebral body family comprised of a variety of sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). The center of the implant is hollow and is to be filled with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone. The superior and inferior surfaces include either the Chemtex® surface treatment or nanoLOCK® surface treatment (MMNTM) designed to improve fixation to the adjacent bone. The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale features. This submission seeks to expand the indications of these devices to include use with demineralized allograft bone with bone marrow aspirate.

The provided text is a 510(k) premarket notification for a medical device called the "ENDOSKELETON® Interbody Fusion Device" system. This document addresses an expansion of indication for use rather than a new device submission. As such, it does not contain information typically found in a study demonstrating primary device performance against acceptance criteria.

Specifically, the document states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because the provided document explicitly states that no such testing was performed for this specific submission.

The submission is for modifying the indications for use of an already cleared device system to include the use of demineralized allograft bone with bone marrow aspirate. The rationale for substantial equivalence is based on:

1. Literature review: The review concluded that there were "no additional risks due to the modification of the indications for these devices to include use with demineralized allograft bone with bone marrow aspirate."
2. Similarities to predicate devices: The intended use, material, surgical technique, surface treatment, sterility, and design of the subject devices are the same as the predicate devices.

In summary, the document does not contain the information requested about acceptance criteria or performance study details.

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The Endoskeleton® TCS Interbody Fusion Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous bone. The device is a stand-alone system when used with Endoskeleton® TCS Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces have been acid etched through a previously cleared process called nanoLOCK™ (MMN™) to improve fixation to the adjacent bone.

The purpose of this special 510(k) submission is to add a plate to the Endoskeleton® TCS System. The ENDOSKELETON® TCS Plate Device (Plate) is compatible with the ENDOSKELETON® TCS Interbody Fusion Device product family. The design incorporates a locking screw to secure the Interbody Fusion Device and is engaged after the placed on the anterior face of the ENDOSKELETON® TCS Interbody Fusion Device to resist the integrated screws from backing out. The system includes a holding feature on the Plate to mate with the inserter to facilitate placement onto the ENDOSKELETON® TCS Interbody Fusion Device implant. Use of this plate is an enhancement to the existing Endoskeleton® TCS system and, as such, is optional with the Endoskeleton® TCS Interbody Fusion Device and does not qualify as supplemental fixation. The subject plate does not include nanoLOCK® (MMN™) surface treatment, as it does not interface with the bone.

The construct is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-EL)) and may be provided either sterile. The subject Endoskeleton® TCS Plate is only provided sterile by gamma irradiation.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance in relation to those criteria, or details regarding a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification summary for the Endoskeleton® TCS Interbody Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices for regulatory clearance, rather than presenting a detailed study evaluating specific performance metrics against pre-defined acceptance criteria.

The "Performance Testing" section states: "Performance bench testing, including locking plate resistance to screw push-out and retention force of the plate holder, was performed to demonstrate substantial equivalence." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment.
• Information about expert involvement or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) study or standalone algorithm performance, as this device is a physical interbody fusion device, not an AI or imaging device.

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The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment pror to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine.

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine. All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI). The primary modification being made in this submission is that the hex size on the screws is being changed from T6 to T8 and as a result the heights now range from 13 – 21.35mm. As a result, there was a small change to the overall length of the screws and a change to the instruments associated with the hex update.

This FDA 510(k) summary for the Endoskeleton® TCS Interbody Fusion Device (K151596) deals with a minor modification to an already cleared device (predicate device K142940). Therefore, the provided text does not contain the detailed information typically found in a new device's acceptance criteria and study report.

Specifically, this document describes a modification to the hex size of the screws used with the device and a slight change in the screw heights. It argues for substantial equivalence to the predicate device without conducting new performance studies for these modifications, relying instead on an "engineering rationale."

Therefore, for this particular submission (K151596), many of the requested sections about acceptance criteria and study details cannot be fully answered. This document provides an engineering rationale for why these minor changes do not impact safety and effectiveness, rather than reporting on new performance studies.

Here's a breakdown based on the provided text, indicating where information is present and where it is explicitly stated as not applicable due to the nature of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or new reported device performance for K151596 because it's a modification to an already cleared device. The manufacturer states that the modifications (hex size and screw height) do not impact the overall function, and thus, no new performance testing was deemed necessary. The "reported device performance" is essentially that the modified device performs equivalently to the predicate device based on engineering rationale.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. No new test set or data provenance is mentioned for K151596 as no new performance studies were conducted for this specific modification. The submission relies on the prior clearance (K142940) for such information.

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)

Not applicable. No new test set requiring expert ground truth establishment was created for K151596 since no new performance studies were conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned for K151596 as no new test set needing adjudication was generated.

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

Not applicable. This device is an interbody fusion device, which is a physical implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are not relevant to this type of medical device.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical implant, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new ground truth was established for K151596 as no new performance studies were conducted. The substantial equivalence argument rests on the predicate device's prior approval.

8. The sample size for the training set

Not applicable. This is a physical implant, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set or ground truth for a training set for this physical medical device.

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