# K233735: ADIRA™ Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 25, 2024 after 64 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K841189 (1984). 674 ancestors in all.
No later device cites it as a predicate yet.
1 of 675 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120092: Plymouth Thoracolumbar Plate System, Globus Medical, Inc. (2012) Summary page 5.
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System, Globus Medical, Inc. (2018) Summary page 5.
- K103382: Intercontinental Plate-Spacer, Globus Medical, Inc. (2011) Summary page 5.
- K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers, Globus Medical, Inc. (2021) Summary page 5.
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS), 4Web, Inc. (2021) Summary page 5.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 5.

## Indications for use
ADIRA™ Lateral Plate System The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spinal surgery. The ADIRA™ 1-Hole Plate is intended to stabilize allograft or autograft at one level (T1-L5), aiding in spinal fusion and to provide temporary stabilization and augment development of a spinal fusion. It may be used alone or with other anterior, lateral, anterolateral, or posterior spinal systems. The device is not intended for load bearing applications. ADIRA™ Plate-Spacer Assemblies ADIRA™ Plates may be assembled to a lateral lumbar interbody fusion device (HEDRON® L, TransContinental®, RISE®-L, Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers) to create a plate-spacer assembly. When assembled to HEDRON® L, TransContinental®, or RISE®-L Spacers, the plate-spacer assembly is indicated for use at one or more levels of the lumbosacral spine (L1-L5), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. When ADIRA™ Plates are assembled to Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers, the plate-spacer assembly takes on the indications of the interbody device. ADIRA™ Plate-Spacers are intended to be used with screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, the 2-Hole or 4-Hole Plate-Spacers are intended for stand-alone use in patients with DDD at one or two levels only when <20° lordotic implants are used with two or four screws, respectively. ADIRA™ Plate-Spacers are to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

Source page: https://510kreport.com/device/K233735
Methodology: https://510kreport.com/methodology