# K172328: SOVEREIGN™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 2, 2017 after 92 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: 20 generations back to K841189 (1984). 275 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 306 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091813: Intrepid Spinal System, Medtronic Sofamor Danek (2009) Summary page 5.
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K170592: NuVasive BASE Interfixated Titanium System, Nu Vasive, Incorporated (2017) Summary page 5.
- K133205: Capstone PTC Spinal System, Clydesdale PTC Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K162680: SOVEREIGN® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5.
- K162212: Divergence-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5.
- K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 6.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 6.
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst, Medtronic Sofamor Danek, Inc. (2013) Summary page 6.

## Most influential descendants
- 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
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own

## Indications for use
The Sovereign™ Spinal System is indicated for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate 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. Additionally, the Sovereign™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be skeletally mature and have had 6 months of non-operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. The Sovereign™ Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Sovereign™ Spinal System 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. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).

Source page: https://510kreport.com/device/K172328
Methodology: https://510kreport.com/methodology