# K022791: Synthes Anterior Tension Band (Atb) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 13, 2002 after 83 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
No predicates in its family tree.
581 later devices descend from it; 15 cite it directly.
1 of 582 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K063158: Synthes Antegra System (2006), 477 descendants of its own
- 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

## Indications for use
The Synthes Anterior Tension Band System is indicated 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. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S 1) spine instability as a result of 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, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K022791
Methodology: https://510kreport.com/methodology