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Reef TO/TA System: When used as an intervertebral body fusion device, the Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device 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 fission and supplemental fixation.

Regatta Lateral System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Regatta Lateral 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 ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System is intended for use with supplemental fixation. TruProfile Interbody Implants: The Regatta Lateral 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 L2 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). The interior of the spacer component may be packed with autogenous bone graff 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System assembled with the 1 - hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

Explorer TO System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in sketally mature patients with degenerative disc disease (DDD). 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). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device 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 and supplemental fixation.

WaveForm C Interbody System: The WaveForm C Interbody System are interbody fusion devices intended for use in skeletally mature patient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. 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. These devices are to be filled with autograft bone and/or allogenic 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. When used as a standalone system, the WaveForm C Interbody System, which includes the 2,3,4-hole TruProfile plates and 2-hole No-profile interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. When the WaveForm C Interbody (excluding 2-hole No-profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

WaveForm TO Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

WaveForm TA Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

FORZA XP Expandable Spacer: FORZA XP Expandable Spacer 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-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 at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treated with FORZA XP Expandable Spacer System.

Shoreline ACS and RT Interbody System: Shoreline ACS Interbody System: The Shoreline ACS Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature had at least six (6) weeks of non-operative treatment. These devicesare to be filled with autograft bone and/or allogenic 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. When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and Noprofile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with > 20° lordosis are intended to be used with supplemental fixation. When the Shoreline ACS Interbody (excluding the No-profile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1). Shoreline RT Interbody System: The Shoreline RT Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. 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. These devices are to be filled with autograft bone and/or allogenic 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. When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation. When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

Meridian Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Meridian System with NanoMetale@ surface technology when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 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 should be skeletally mature and have had at least six (6) months of non-operative treatment. The interded 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 Meridian Interbody is intended for use with supplemental fixation. No-Profile Interbody Implants with Screws: The Meridian System 2-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, 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 L2 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 cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion. The Meridian System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. The Meridian System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, 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 L2 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. The Meridian System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw traiectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-Profile Interbody Implants with Inline Fixation Anchors: The Meridian System No-profile Interbody, when used with Inline Fixation Anchors and a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 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, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The Meridian System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 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. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

WaveForm A Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 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 should be skeletally mature and have had at least six (6) months of non-operative treatment. 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 A System Interbody is intended for use with supplemental fixation. No-profile Interbody Implants with Screws: The WaveForm A System 2-Hole and 3-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, 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 L2 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 cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperloriosis sizes (greater than 20°) are intended for use with supplemental fixation. The WaveForm A System 4-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, 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 L2 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-overative 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. The WaveForm A System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw traiectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-profile Interbody Implants with Inline Fixation Anchors: The WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. 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 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 WaveForm A System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The WaveForm A System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 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 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. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Reef TO/TA System: The Reef TO/TA Interbody System featuring NanoMetalene® surface technology consists of straight, rectangular-shaped (Reef TO) and curved, banana-shaped (Reef TA), posterior lumbar 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 laver 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, 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 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.

Regatta Lateral System: The Regatta Lateral System featuring NanoMetalene surface technology consists of lateral lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (ASTM F2026) with from tantalum (per ASTM F560) radiographic markers and a one-micron thick surface layer of commercially pure titanium (per ASTM F67). 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 and supplemental fixation. The spacers are individually packaged and gamma sterilized. The Regatta Lateral 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-6A1-4V 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.

Explorer TO System: The Explorer TO System is a lumbar intervertebral body fusion device used to act as a disc spacer and hold bone graft to promote fusion in the lumbar spine. The system consists of non-sterile implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system is comprised of height expandable and lordotic expandable interbody spacers, and both configurations are available in a range of lengths, widths, heights, and lordotic angles. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm C Interbody System: The WaveForm C Interbody System consists of anterior cervical intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged and gamma sterilized. The WaveForm C Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile and No-profile configurations. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). 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 TO Interbody System: The WaveForm TO Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The straight, rectangular-shaped 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 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 TA Interbody System: The WaveForm TA Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The curved, banana-shaped 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 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.

FORZA XP Expandable Spacer System: The FORZA XP Expandable Spacer System is comprised of an assortment of single-use spacers made from titanium alloy and PEEK polymer with height expansion capability. The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device. FORZA XP spacers are provided in both sterile and non-sterile configurations. The implants are offered in non-lordotic, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device and must be used with a supplemental fixation system.

Shoreline ACS Interbody System: The Shoreline ACS Interbody System featuring NanoMetalene® surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a onemicron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The Shoreline ACS Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configurations. The fixation implants are manufactured from titanium allov (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Shoreline RT Interbody System: The Shoreline RT Interbody System featuring NanoMetalene® surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6A1-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a onemicron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The Shoreline RT Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System nonsterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). 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.

Meridian Interbody System: The Meridian Interbody System featuring NanoMetalene® surface technology consists of anterior lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology 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 a central graft window for receiving autogenous and/or allogenic 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 and supplemental fixation. The spacers are individually packaged and gamma sterilized. The Meridian Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6A1-4V 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 travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm A Interbody System: The WaveForm A Interbody System consists of anterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints. heights, and lordotic options to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The interbody spacers, which include a central graft window for receiving autogenous and/or allogenic 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 and supplemental fixation, are individually packaged and gamma sterilized. The WaveForm A Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6A1-4V 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.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided text, the submission is not about a medical device with an artificial intelligence/machine learning (AI/ML) component or software. The text describes various intervertebral body fusion devices, their indications for use, and their technological characteristics. The "performance testing summary" explicitly states:

"The purpose of this submission is to expand the indications for use of the Orthofix Medical Inc. Interbody System devices to include use in the use of a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Because the subject device is identical to the previously cleared primary predicate devices (K231076. K221751. K203714. K231735), it was determined that existing testing data is adequate to support the expanded indications proposed in the current submission."

This indicates that the submission relies on comparison to predicate devices and existing testing data for mechanical and material properties, rather than new studies demonstrating software performance, AI efficacy, or human-in-the-loop improvements. Therefore, most of the requested information regarding acceptance criteria for AI models, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable.

However, I can extract the relevant information about the "acceptance criteria" and the "study" that proves the device meets them in the context of this 510(k) submission, even without an AI component.

Acceptance Criteria and Device Performance (in the context of a 510(k) "Substantial Equivalence" claim):

Study Information (Based on the provided Text):

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

   • Not Applicable in the traditional sense for testing an AI model. This submission relies on a claim of "substantial equivalence" to predicate devices. There is no new test set of patient data being evaluated for the device's performance because the device itself (hardware) hasn't changed, only the allowable bone graft material. The "testing data" referenced is existing data from the predicate devices. The document does not specify the provenance of this existing data.

2. 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. There is no "test set" in the context of an AI model requiring expert-established ground truth. The acceptance is based on engineering principles, material science, and comparison to legally marketed predicate devices.

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

   • Not applicable. See point 2.

4. 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. This is not an AI/ML device, so an MRMC study is not relevant to this submission.

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

   • No. This is not an AI/ML device.

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

   • Not applicable for an AI ground truth. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices for their stated indications, combined with engineering and material testing data demonstrating their mechanical properties and biocompatibility.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device.

Summary regarding AI/ML:

The provided document describes a 510(k) submission for intervertebral body fusion devices. The core of the submission is to expand the indications for use of these existing devices to include the use of bone void fillers. The approval is based on demonstrating substantial equivalence to previously cleared predicate devices, asserting that the subject devices are "identical in all respects except for the indications for use" and that "existing testing data is adequate." Therefore, this document does not contain information related to AI/ML acceptance criteria, performance studies, or ground truth establishment.

Ask a specific question about this device

FORZA XP Expandable Spacer 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-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 at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.

The FORZA XP Expandable Spacer System is comprised of an assortment of single use spacers made from titanium alloy and PEEK Polymer with height expansion capability. The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The implants are offered in non-lordotic, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).

The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device and must be used with a supplemental fixation system.

The provided text describes a 510(k) premarket notification for the FORZA XP Expandable Spacer System. However, it does not contain any information about acceptance criteria or a study proving the device meets performance criteria, especially regarding AI/algorithm performance.

The document explicitly states:

• "No new mechanical testing was performed for the FORZA XP Expandable Spacer System because there were no design changes to the device."
• "The proposed sterile package offering does not change the design, materials, function, performance for the FORZA XP implants most recently cleared thru 510(k) K211704."
• "FORZA XP Expandable Spacer System has the same intended use, indications for use, technological characteristics, materials, the same principles of operation and same design as the predicate device FORZA XP Expandable Spacer System (K211704)."

This 510(k) submission is a "Product Line Extension" for a physical medical device (an expandable spinal spacer), primarily addressing a sterile packaging configuration change from a previously cleared device (K211704). It does not involve any AI/algorithm component.

Therefore, I cannot fulfill your request for information about acceptance criteria or a study related to AI/algorithm performance, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for AI, as this information is not present in the provided document.

If you have a document describing an AI/algorithm-based device, please provide that document, and I would be happy to describe the acceptance criteria and study as requested.

Ask a specific question about this device

When Used as a Cervical Intervertebral Body Fusion System:

The CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When Used as a Partial Vertebral Body Replacement (VBR) System:

The CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. Lordotic implants greater than a 5° profile are not to be used for partial vertebral body replacement.

The CONSTRUX Mini PEEK Spacer System 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 of time. The Partial VBR Device is intended to be used with autograft or allograft and supplemental fixation system.

The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.

The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini Ti Spacer System is intended for use with autograft comprised of cancellous and/ or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.

The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

The FORZA PTC Spacer 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-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 at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.

The FORZA Ti Spacer 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-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 at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA Ti Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.

The FORZA XP Expandable Spacer 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-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 at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA XP Expandable Spacer System.

The LONESTAR Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The LONESTAR Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the LONESTAR Cervical Stand Alone System in the cervical spine.

The PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach.

The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach.

The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach.

The PILLAR XL PEEK Spacer is used singly and is implanted using a lateral approach.

The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR) Device:

The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

When used as an Intervertebral Body Fusion Device:

The PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Orthofix Firebird Spinal Fixation System.

The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR) Device:

The PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR SA PEEK Spacer System 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 of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Firebird System.

The PILLAR SA PTC Spacer 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-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 at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).

The PILLAR SA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.

The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. If the physician chooses to use fewer than four of the provided screws then supplemental fixation must be used to augment stability. As an example, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.

When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System – The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with titanium markets as described by ASTM F67. The implants are available in multiple sizes to accommodate various patient anatomies. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The CONSTRUX Mini PEEK VBR System is intended for vertebral body replacement to aid in the surqical correction and stabilization of the spine.

The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System implants are provided either in a sterile packaging configuration or non-sterile and requires sterilization prior to use.

CONSTRUX Mini PTC Spacer System - The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that have a PEEK core with integrated porous titanium end plates. CONSTRUX Mini PTC spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini PTC Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini PTC implants are provided sterile.

CONSTRUX Mini PTC implants are design to be used with CONSTRUX Mini PEEK Spacer System instrumentation. The CONSTRUX Mini PTC implants are not compatible with components or metal from any other manufacturer's system.

CONSTRUX Mini Ti Spacer System - The CONSTRUX Mini Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure. CONSTRUX Mini Ti spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini Ti implants are provided sterile.

CONSTRUX Mini Ti implants are design to be used with CONSTRUX Mini Spacer System instrumentation. The CONSTRUX Mini Ti implants are not compatible with components or metal from any other manufacturer's system.

FORZA PEEK Spacer System - The FORZA Spacer System consists of implants, trials and instruments. The system is comprised of a variety of implants fabricated and manufactured from polvetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants both intraoperatively and postoperatively.

FORZA Spacer System implants are offered in two geometric shapes – straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine and are implanted using a posterior approach.

The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with a supplemental fixation system. The implants are provided sterile but the instruments are provided non-sterilization prior to use.

FORZA PTC Spacer System - The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK (OPTIMA LT1) core with integrated porous titanium (Ti-6Al-4V) end plates as well as a tantalum marker that acts as a visual aid for the surgeon in determining the location of the implant both intraoperatively and postoperatively.

FORZA PTC Spacer System implants are offered in two geometric shapes - straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the spine. The implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and a roughened surface on both the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and are implanted using a posterior approach.

The FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC Spacer System must be used with a supplemental fixation system.

The FORZA PTC Spacer System implants are provided sterile.

FORZA PTC implants are designed for use with FORZA PEEK Spacer System instrumentation. The FORZA PTC spacers are not compatible with components or metal from any other manufacturer's system.

FORZA Ti Spacer System - The FORZA Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure.

FORZA Ti Spacer System implants are offered in two geometric shapes - straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the spine. The implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and a roughened surface on both the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Ti Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and are implanted using a posterior approach.

The FORZA Ti Spacer System is not intended to be used as a standalone device. The FORZA Ti Spacer System must be used with a supplemental fixation system.

The FORZA Ti Spacer System implants are provided sterile.

FORZA Ti implants are designed for use with FORZA PEEK and FORZA PTC Spacer System instrumentation. The FORZA Ti spacers are not compatible with components or metal from any other manufacturer's system.

FORZA XP Expandable Spacer System - The FORZA XP Expandable Spacer System is comprised of an assortment of non-sterile, single use, titanium allov (Ti-6AI-4V ELI per ASTM F136) and Polyetheretherketone (PEEK) Polymer (PEEK OPTIMA® LT1 per ASTM F2026) spacers with height expansion capability. The expandable interbody spacer is inserted into the lumbar disc space and expanded to fit the patient anatomy.

The implants are offered in parallel, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).

The implants feature a bulleted nose for ease of insertion ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device. The system must be used with a supplemental fixation system, is provided non-sterile and requires sterilization prior to use.

Lonestar Cervical Standalone System - The LONESTAR Cervical Stand Alone System is a stand-alone spacer system designed to provide biomechanical strength to a traditional or minimally invasive ACDF procedure with less disruption of patient anatomy and preservation of the anatomical profile. The system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability.

The LONESTAR implant consists of a hybrid PEEK and titanium spacer along with titanium bone screws and a titanium cover plate. The spacers are designed with a zero degree anterior profile and are implanted using an anterior approach.

The LONESTAR Cervical Stand Alone implants and instruments are provided non-sterile and will require thorough cleaning and sterilization prior to each use. The implants are not compatible with components or metal from any other manufacturer's system.

PILLAR PEEK Spacer System - The PILLAR PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone) as described by ASTM F2026 with tantalum markers as described by ASTM F560. The implants are available in a variety of sizes and are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights in either one or two millimeter increments. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR PEEK Spacer System is intended for intervertebral body fusion or partial vertebral body replacement to aid in the surgical correction and stabilization of the spine.

The PILLAR PEEK Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The system is provided non-sterile and requires sterilization prior to use.

PILLAR SA PEEK Spacer System - The PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone) as described by ASTM F2026 with tantalum markers as described by ASTM F560. The implants are available in multiple footprints, a variety of heights, and two angles of lordosis: 7° and 12°. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent of the device.

The PILLAR SA PEEK Spacer System is provided non-sterile.

PILLAR SA PTC Spacer System - The PILLAR SA PTC Spacer System is comprised of a variety of implants that have a PEEK core with integrated porous titanium end plates. The implants incorporate integrated anterior screw holes to allow for medial placement of bone screws as well as a titanium plate for securing the bone screws once in place. The implants are designed with a roughened surface on the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR SA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and is implanted using an anterior approach.

The PILLAR SA PTC spacers are provided sterile. The cover plate, screws and instruments are provided non-sterile and require sterilization prior to use.

The PILLAR SA PTC implants are designed to be used with PILLAR SA PEEK Spacer System instrumentation. The implants are not compatible with components from any other manufacturer's system.

SKYHAWK Lateral Interbody Fusion System - The SKYHAWK Lateral Interbody Fusion System consists of implants, trials, and instruments and is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent property, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the implants, both intraoperatively and postoperatively.

The SKYHAWK Lateral Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device may be implanted using a lateral approach.

The SKYHAWK Lateral Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use.

The provided text is a 510(k) Summary for multiple spinal implant systems, focusing on the addition of "MR Conditional" labeling. It details the device descriptions and indications for use but does not contain information about acceptance criteria or a study proving clinical effectiveness or device performance in the context of typical medical device evaluation (e.g., diagnostic accuracy, treatment efficacy in patients).

Instead, the "performance data" section (page 26) pertains to the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment to support the MR Conditional labeling. This is a specific type of performance evaluation, not a general study proving the device meets clinical acceptance criteria for its primary function (spinal fusion).

Therefore, most of the requested information regarding acceptance criteria, patient sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information is not available in the provided document.

Here's a breakdown of what can be extracted or inferred:

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

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

• Test Set Sample Size: Not applicable. The "test set" here refers to the physical devices themselves used for MR compatibility testing, not patient data. The number of devices tested is not specified.
• Data Provenance: Not applicable, as this refers to laboratory testing of physical devices according to ASTM standards, not clinical patient data.

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. Ground truth, in the context of MR compatibility testing, is defined by the ASTM standards and the physical measurements performed, not by expert interpretation of clinical data.

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

• Not applicable. Adjudication is relevant for interpreting ambiguous clinical data, not for laboratory measurements of physical properties.

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 document describes spinal implants, not an AI-assisted diagnostic or treatment system.

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

• Not applicable. This document describes spinal implants, not an algorithm.

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

• For MR Conditional Labeling: Ground truth is established by the specified ASTM standards and physical measurements.
• For Clinical Efficacy (Spinal Fusion Devices): This information is not provided in the document. Clinical ground truth for spinal fusion devices would typically involve imaging (e.g., CT scans to assess fusion), patient reported outcomes, and potentially re-operation rates or other clinical endpoints from previous studies.

8. The sample size for the training set

• Not applicable. This document describes spinal implants, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

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