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510(k) Data Aggregation
K Number
K203065Device Name
Lumbar Spine Truss System Plating Solution (LSTS-PS)
Manufacturer
4Web, Inc.
Date Cleared
2021-03-10
(152 days)
Product Code
KWQ, OVD
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lumbar Spine Truss System Plation (LSTS-PS) without integrated fixation is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The LSTS-PS with integrated fixation is intended to be attached to the Lateral Spine Truss System (LSTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS with integrated fixation is intended to be used with supplemental fixation (e.g. posterior fixation).
Device Description
The Lumbar Spine Truss System Plating Solution (LSTS-PS) is comprised of lumbar plates and screws. The lumbar plates have a rotating locking tab for each screw position to prevent back-out of the screw. The plates are available in 1-hole, and 4-hole integrated configurations and 2-hole and 4-hole non-integrated configurations. Each plate is available in multiple lengths for single level fusion. The screws are available in two diameters and various lengths to accommodate the patient's anatomy. All LSTS-PS plates and screws are made from Ti6Al4V alloy.
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K Number
K200002Device Name
Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device
Manufacturer
4Web, Inc.
Date Cleared
2020-05-29
(148 days)
Product Code
OVD
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a stand-alone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
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K Number
K190870Device Name
Cervical Spinal Truss System-Stand Alone (CSTS-SA)
Manufacturer
4Web, Inc.
Date Cleared
2019-08-12
(131 days)
Product Code
OVE
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment with the devices.
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
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K Number
K190926Device Name
Hammertoe Truss System (HTS)
Manufacturer
4Web, Inc.
Date Cleared
2019-07-23
(105 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
Device Description
The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.
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K Number
K172294Device Name
Osteotomy Truss System (OTS)
Manufacturer
4Web, Inc.
Date Cleared
2018-02-22
(206 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:
-Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
-Opening wedge of Medial Cuneiform or Cotton osteotomies
-Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
-Metatarsal Cuneiform osteotomies
- -Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies(TMT or Lapidus) -Hindfoot osteotomies
These devices are intended to be used with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.
Device Description
The Osteotomy Truss System is a titanium alloy implant used for correction of small bones in the foot. It is offered in three footprints and multiple sizes for each footprint with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4WEB truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.
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K Number
K173159Device Name
Cervical Spinal Truss System (CSTS) Interbody Fusion Device
Manufacturer
4Web, Inc.
Date Cleared
2018-01-08
(101 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device must be used with supplement fixation.
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy.
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K Number
K172392Device Name
Lateral Spinal Truss System (LSTS) Interbody Fusion Device
Manufacturer
4Web, Inc.
Date Cleared
2017-11-07
(91 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lateral Spine Truss System (LSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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 prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.
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K Number
K171351Device Name
Posterior Spine Truss System (PSTS) Interbody Fusion Device
Manufacturer
4Web, Inc.
Date Cleared
2017-09-08
(122 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Posterior Spine Truss System (PSTS) 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 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 prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s)
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.
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K Number
K170851Device Name
Anterior Spine Truss System (STS) Interbody Fusion Device
Manufacturer
4Web, Inc.
Date Cleared
2017-08-07
(138 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anterior Spine Truss System (STS) 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 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 prior to treatment with the device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.
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K Number
K153436Device Name
LATERAL Spine Truss System
Manufacturer
4Web, Inc.
Date Cleared
2016-06-06
(192 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4Web, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lateral Spine Truss System (STS) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-L5. 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 prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Device Description
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The device is available in a variety of sizes to accommodate the patient's anatomy. The implant is made from Ti6Al4V alloy (ASTM F-1108).
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