# K063158: Synthes Antegra System

- Pathway: 510(k) (Special)
- Applicant: Synthes Spine Co.Lp
- Decided: Nov 14, 2006 after 28 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: 1 generation back to K022791 (2002). 1 ancestor in all.
477 later devices descend from it; 3 cite it directly.
1 of 479 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K081568: Antegra-T (2008), 472 descendants of its own
- K121815: Nuvasive Sage Lateral Plate System (2012), 469 descendants of its own
- K131723: Coroent Single Tab System (2013), 466 descendants of its own
- K140479: Coroent XL-F System (2014), 465 descendants of its own
- K160051: NuVasive® Interfixated Interbody System (2016), 396 descendants of its own

## Indications for use
Synthes Antegra System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. Synthes Antegra System is indicated in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of the following: * Fracture (including dislocation and subluxation) * Tumor * Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) * Pseudoarthrosis * Spondylolysis * Spondylolisthesis * Scoliosis * Lordotic deformities of the spine * Spinal stenosis * Failed previous spine surgery. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K063158
Methodology: https://510kreport.com/methodology