# K162680: SOVEREIGN® Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 14, 2016 after 79 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: 16 generations back to K003155 (2001). 157 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121982: Sovereign Spinal System, Medtronic Sofamor Danek (2012) Summary page 4.
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K172328: SOVEREIGN™ Spinal System (2017), 30 descendants of its own
- K191066: CD Horizon™ Astute™ Spinal System (2019), 21 descendants of its own
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (2022), 20 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own
- K233951: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (2024), 5 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 6 months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. 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 3 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 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability.

Source page: https://510kreport.com/device/K162680
Methodology: https://510kreport.com/methodology