# K192281: AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Nov 20, 2019 after 90 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K853033 (1985). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 20.
- K052546: Aegis Anterior Lumbar Plate System, Depuy Spine, Inc. (2006) Summary page 20.
- K953978: Anterior Dynamized System, Acromed Corp. (1997) Summary page 20.
- K943819: Isola Anterior System, Acromed Corp. (1995) Summary page 20.
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 20.
- K944756: Isola Open and Closed Screws, Acromed Corp. (1995) Summary page 20.
- K021039: Bowti Anterior Buttress Staple System, Depuyacromed (2002) Summary page 20.
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 20.
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 20.
- K012916: Frontier Anterior Scoliosis System, Depuy Acromed, Inc. (2001) Summary page 20.
- K873826: Acromed/Kaneda Anterior Spinal Instrumentation, Acromed Corp. (1988) Summary page 20.
- K974757: Kaneda Anterior Scoliosis System Kass, Acromed Corp. (1998) Summary page 20.
- K971248: Kaneda SR Anterior Spinal System, Acromed Corp. (1997) Summary page 20.
- K972718: M-2 Anterior Plate System, Acromed Corp. (1997) Summary page 20.
- K091994: Mountaineer Laminoplasty System, Depuy Spine, Inc. (2010) Summary page 21.
- K973060: Depuy Motech Profile Anterior Thoracolumbar Plate System, Depuy, Inc. (1997) Summary page 21.
- K980228: University Plate Anterior System, Acromed Corp. (1998) Summary page 21.
- K101762: Viper F2 Facet Fixation System, Depuy Spine, Inc. (2010) Summary page 21.

## Indications for use
The AEGIS Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications are: • 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, kyphosis, and/or lordosis); • tumor; • pseudarthrosis; and • previous failed fusion. The Anterior Dynamized system is intended for use in anterior decompression instrumentation and fusion for kyphotic deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic and back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3. The ISOLA Spine System when used as anterior thoracic/lumbar screw fixation system, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The BOWTI Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications. The BOWTI Anterior Buttress Staple System is intended for anterior intravertebral body screw fixation/attachment to the T1-S1 spine over one vertebral body extending into the adjacent intervertebral space. Specifically, the device is intended for stabilization and buttressing of bone graft as an aid to spinal fusion. It may be used with other anterior, anterolateral or posterior spinal systems. The DISCOVERY Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods: Transfacet fixation: The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. Translaminar Facet fixation: The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle. For both methods this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability. The EXPEDIUM Anterior Spine System is intended for anterolateral screw fixation of the T4 to L4 levels of the spine, with metal at least 1 cm from a major vessel. The EXPEDIUM Anterior Spine System may be used in either thoracoscopic procedures or open procedures. The EXPEDIUM Anterior Spine System is indicated for: • 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); • spinal stenosis; • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); • tumor; • pseudarthrosis; and previous failed fusion. The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with metal at least 1cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures. The FRONTIER Anterior Scoliosis System is indicated for: • 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); • spinal stenosis; • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); • tumor; • pseudarthrosis; and previous failed fusion. The KANEDA Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine. The KANEDA Anterior Scoliosis System is indicated for: • 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); • spinal stenosis; • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); • tumor; • pseudarthrosis; and previous failed fusion. The KANEDA SR Anterior Spinal System is intended for anterolateral screw fixation to the T10 to L3 levels of the spine. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The intended levels for treatment with the M-2 Anterior Plate System are from T3 to L3. In order to treat levels from T3 to L3, plate attachment is from T2 to L4. The M-2 Anterior Plate System is intended to treat one motion segment per construct. The M-2 Anterior Plate System is indicated for: • 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); • spinal stenosis; • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); • tumor; • pseudarthrosis; and previous failed fusion. The MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord. The intended levels for treatment with the PROFILE Anterior Thoracolumbar Plate System are from T1-L5 spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The UNIVERSITY PLATE Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for the attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). The VIPER F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only: Transfacet fixation: The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

Source page: https://510kreport.com/device/K192281
Methodology: https://510kreport.com/methodology