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When used as an interbody fusion device, the ProLift® Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The ProLift® Lateral Fixated is an interbody fusion device 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). The ProLift® Lateral Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation.

The ProLift® Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 26mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Expandable Spacer System components with components from any other system or manufacturer. The ProLift® Expandable Spacer System components should never be reused under any circumstances.

The ProLift® Lateral Fixated is an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration. The screws are manufactured in variable and fixed configurations with diameters of 5.5mm and 6.5mm and lengths of 25mm-60mm. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.

All implants are provided and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Lateral Fixated with components from any other system or manufacturer. The ProLift® Lateral Fixated components should never be reused under any circumstances.

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The Titanium Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Titanium Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Titanium Interbody System.

The Titanium Interbody System is an expandable interbody fusion device and corresponding instruments intended to stabilize a spinal segment to promote fusion. The implant is sold sterile and is available in various sizes to accommodate varying patient anatomy.

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IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D Universal Implant Inserter is IB3D™ PL Spinal System instrument made of stainless steel. The Reusable Instruments are designed for use in orthopedic procedures to facilitate the insertion and rotation of IB3D™ PL implants into the lumbar spine. These instruments enable placement of the interbody implant between two lumbar vertebral bodies by allowing the implant to be inserted and rotated into its final position. The inserter comprises a handle and a shaft that securely holds the implant, with rotation achieved via the handle. The implant device is constructed from titanium alloy.

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The ZSFab Lumbar Interbody System is intended for lumbar interbody

The ZSFab Lumbar Interbody System is intended for lumbar interbody

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The UniSpace® TPLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The UniSpace® TPLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the UniSpace® TPLIF Cage is to be used with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.

The UniSpace® TPLIF Cage is a product for lumbar spinal column stability. The implants of the UniSpace® TPLIF Cage are made of ASTM F3001 titanium alloy (Ti6Al4V ELI) and manufactured using an additive manufacturing method (3D printing), specifically Direct Metal Laser Sintering (DMLS). The UniSpace® TPLIF Cage is available in various heights, widths, lengths, and lordotic angles, and features an open architecture designed to accommodate autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft. The cages are provided in a variety of sizes to accommodate individual patients' anatomical requirements. The implants of the UniSpace® TPLIF Cage are provided as a sterile pack. The UniSpace® TPLIF Cage is implanted by using instruments manufactured from stainless steel material (ASTM F899) and/or Ti6Al4V ELI (ASTM F136).

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The Spectrum Spine Expandable Titanium PLIF/TLIF System includes 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).

Spectrum Spine Expandable Titanium PLIF/TLIF System implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to a set height and lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is 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.

The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136.

The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand to a set height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.

The purpose of this special 510(k) is to gain clearance for modifications made to the Expandable Titanium PLIF/TLIF System.

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Mobarn 80:20 Lumbar Interbody Fusion System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Mobarn 80:20 Lumbar Interbody Fusion System is to be combined with supplemental fixation.

The Mobarn 80:20 Lumbar Interbody Fusion System consists of a family of additively manufactured titanium (Ti6Al4V-ELI) lumbar intervertebral body fusion devices (LIBF) designed to facilitate lumbar spinal fusion through various surgical approaches, as listed below.

• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Direct Lateral Lumbar Interbody Fusion (DLIF)
• Anterior Lumbar Interbody Fusion (ALIF)

The Mobarn 80:20 Lumbar Interbody Fusion System is intended for use in lumbar intervertebral fusion procedures. These devices are designed to provide structural support and stabilization to facilitate bony fusion in patients with degenerative disc disease (DDD) and other conditions requiring interbody fusion.

The design of the implants consists of an open architecture surrounded by a titanium frame to accommodate autograft and/or allogenic bone graft, comprised of cancellous and/or cortico-cancellous bone graft. Each implant is engineered with an 80% open area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, maximizing bone graft contact and fusion potential, while maintaining mechanical integrity through a titanium frame that makes up the remaining 20% and offers structural support. The implants are available in a variety of footprints, heights, and lordotic angles to approximate anatomical variation in different vertebral levels and/or patient anatomy.

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Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers 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 or retrolisthesis at the involved level(s).

Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Apelo™ Pedicle Screw System.

Not Found

The provided FDA 510(k) clearance letter for the "Atlas Spine Project X Expandable Posterior Lumbar Interbody System" does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria.

The letter is a regulatory document confirming that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, classification, and applicable regulations (such as Quality System regulations, UDI rules, and adverse event reporting).

Therefore, I cannot provide the requested information from the given input because the document does not contain details about:

1. Acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for any test set.
3. MRMC comparative effectiveness study results.
4. Standalone performance studies.
5. Type of ground truth used.
6. Training set sample size or how its ground truth was established.

The letter mentions the "Indications for Use" for the device, detailing the patient population and conditions for which it is intended, but this is distinct from performance criteria and study results.

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