# K012916: Frontier Anterior Scoliosis System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Acromed, Inc.
- Decided: Nov 27, 2001 after 89 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 K953915 (1996). 3 ancestors in all.
601 later devices descend from it; 3 cite it directly.
1 of 605 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953915: Moss Miami Spinal System (Anterior Use), Depuy, Inc. (1996) Summary page 1.
- K974757: Kaneda Anterior Scoliosis System Kass, Acromed Corp. (1998) Summary page 1.
- K001066: CD Horizon Eclipse, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.

## Most influential descendants
- K071668: Orthobiom Spinal System (2008), 582 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K110070: TSRH Spinal System (2011), 269 descendants of its own
- K111457: CD Horizon Spinal System (2011), 261 descendants of its own
- K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own

## Indications for use
The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures. The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are: 1. Idiopathic scoliosis. 2. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. Neuromuscular scoliosis/kyphoscoliosis. Spinal fractures (acute reduction or late deformity). Revision surgery. Tumor. The FRONTIER Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include: . Collapsing and unstable paralytic deformity. 1 2. Progressively increasing scoliosis. 3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. Inability to maintain sitting balance, necessitating the use of hands. Increasing pelvic obliquity coincident with back pain or losg of sitting balance.

Source page: https://510kreport.com/device/K012916
Methodology: https://510kreport.com/methodology