# K213460: Invictus Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Dec 10, 2021 after 44 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K841189 (1984). 703 ancestors in all.
17 later devices descend from it; 1 cites it directly.
2 of 721 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203056: Invictus™ Spinal Fixation System, Alphatec Spine, Inc. (2020) Summary page 4.
- K173095: VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations, Medos International SARL (2017) Summary page 4.

## Most influential descendants
- K214006: Invictus® Spinal Fixation System (2022), 16 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K232044: Invictus Robotic Navigation Instruments (2023), 3 descendants of its own

## Indications for use
The Invictus 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 Invictus 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 Invictus 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 Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K213460
Methodology: https://510kreport.com/methodology