# K221403: Cortera Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgalign Spine Technologies
- Decided: Aug 19, 2022 after 95 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K841189 (1984). 686 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 690 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192938: Invictus™ Spinal Fixation System, Alphatec Spine, Inc. (2019) Summary page 4.

## Most influential descendants
- K241892: Cortera™ Spinal Fixation System (2024), 2 descendants of its own
- K243946: EffortMed Spinal Fixation System (2025), 1 descendant of its own
- K254247: Osteomni Spinal Fixation System (2026), 0 descendants of its own

## Recalls of this device
- Aug 21, 2024 · Class II · Z-0125-2025: Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the sc
- Nov 28, 2023 · Class II · Z-0846-2024: Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5

## Indications for use
The Cortera™ Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera™ Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera™ Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.

Source page: https://510kreport.com/device/K221403
Methodology: https://510kreport.com/methodology