# K211712: 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix US, LLC
- Decided: Feb 11, 2022 after 253 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: 8 generations back to K922087 (1992). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020620: Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer), Blackstone Medical, Inc. (2002) Summary page 10.
- K030595: Blackstone Fusion Anterior Cervical Plating System, Blackstone Medical, Inc. (2003) Summary page 10.
- K061229: Unity LX Anterolateral Lumbar Plate Fixation System, Blackstone Medical, Inc. (2006) Summary page 10.
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates, Blackstone Medical, Inc. (2010) Summary page 10.
- K043338: Blakstone Laminoplasty Fixation System, Blackstone Medical, Inc. (2005) Summary page 10.
- K162638: CETRA Anterior Cervical Plate System, Orthofix, Inc. (2016) Summary page 10.

## Indications for use
The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies). 2. Spondylolisthesis 3. Fracture 4. Spinal stenosis 5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 6. Tumor 7. Pseudoarthrosis 8. Revision of previous surgery The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies). 2. Spondylolisthesis 3. Fracture 4. Spinal stenosis 5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 6. Tumor 7. Pseudoarthrosis 8. Revision of previous surgery The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis. 3. Spondylolysis. 4. Spondylolisthesis. 5. Fracture. 6. Neoplastic disease. 7. Unsuccessful previous fusion surgery. 8. Lordotic deformities of the spine. 9. Idiopathic thoracolumbar or lumbar scoliosis. 10. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele. 11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity. The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies). 2. Spondylolisthesis 3. Fracture 4. Spinal stenosis 5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 6. Tumor 7. Pseudoarthrosis 8. Revision of previous surgery The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord. The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies). 2. Spondylolisthesis 3. Fracture 4. Spinal stenosis 5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 6. Tumor 7. Pseudoarthrosis 8. Revision of previous surgery

Source page: https://510kreport.com/device/K211712
Methodology: https://510kreport.com/methodology