# K110063: Sovereign Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Oct 4, 2011 after 267 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 32 ancestors in all.
718 later devices descend from it; 3 cite it directly.
1 of 751 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091813: Intrepid Spinal System, Medtronic Sofamor Danek (2009) Summary page 2.

## Most influential descendants
- K120869: Anchor-L Lumbar Cage (2012), 638 descendants of its own
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (2015), 636 descendants of its own
- K143616: AccuLIF TL and PL Cage (2015), 469 descendants of its own
- K152304: Tritanium PL Cage (2015), 448 descendants of its own
- K153782: NuVasive® Lumbar Interbody Implants (2016), 390 descendants of its own

## Indications for use
The SOVEREIGN Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The SOVEREIGN interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

Source page: https://510kreport.com/device/K110063
Methodology: https://510kreport.com/methodology