SOVEREIGN™ Spinal System

K172328 · Medtronic Sofamor Danek USA, Inc. · OVD · Nov 2, 2017 · Orthopedic

Device Facts

• Record ID: K172328
• Device Name: SOVEREIGN™ Spinal System
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Nov 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sovereign™ Spinal System is indicated for use with autogenous bone graft 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™ 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. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).

Device Story

Intervertebral body fusion device; provides structural support to lumbar spine; facilitates fusion via autogenous/allograft bone graft. Implanted via open or minimally invasive anterior/oblique approaches. Used as stand-alone (with 3 titanium alloy screws and cover plate) or with supplemental fixation. Surgeon-operated; used in clinical/OR settings. Provides mechanical stability to spinal segments; promotes bone fusion; alleviates discogenic pain. Subject device adds PEEK implant lordosis options and PTC (Commercially Pure Titanium) coated implant options to existing system.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static compression, compression fatigue, static compression shear, compression shear fatigue, subsidence, and expulsion testing per ASTM F2077, ASTM F2267, and ASTM Draft F-04.25.02.02. All implants met pre-determined acceptance criteria.

Technological Characteristics

Intervertebral body fusion device; materials include PEEK and Commercially Pure Titanium (CP Ti) coating. Features internal screw fixation (titanium alloy). Mechanical testing per ASTM F2077, ASTM F2267, and ASTM Draft F-04.25.02.02. MR-Conditional.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) or multilevel degenerative scoliosis and sagittal deformity as an adjunct to fusion. Requires 6 months of failed non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• SOVEREIGN™ Spinal System (K091813)
• DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System (K150135)
• BASE Interfixated Titanium System (K170592)
• CLYDESDALE™ PTC Spinal System (K133205)
• SOVEREIGN™ Spinal System (K162680)
• DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System (K162212)
• CLYDESDALE™ Spinal System (K132897)
• LT-CAGE™ PEEK Lumbar Tapered Fusion Device (P970015)
• SOVEREIGN™ Spinal System (K122037)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

August 30, 2021

Medtronic Sofamor Danek, USA Inc. Kanesha Hines Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132

Re: K172328

Trade/Device Name: SOVEREIGN™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD

Dear Ms. Hines:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 2, 2017. Specifically, FDA is updating this SE Letter as an administrative correction, to update the Indications for Use and labeling.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, [phone], [e-mail].

Sincerely,

Brent Showalter -S

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtronic Sofamor Danek, USA Inc. Kanesha Hines Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132

November 2, 2017

### Re: K172328

Trade/Device Name: SOVEREIGN™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: October 3, 2017 Received: October 4, 2017

Dear Ms. Hines:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172328

Device Name Sovereign™ Spinal System

#### Indications for Use (Describe)

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 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 sketally 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) must be used. These implants may be inplanted via a variety of open or minimally invasive 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).

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="padding-right: 5px;"> <div style="display:inline-block; width:15px; height:15px; border:1px solid black; text-align:center;"><b>X</b></div> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right: 5px;"> <div style="display:inline-block; width:15px; height:15px; border:1px solid black;"></div> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(k) SUMMARY

# MEDTRONIC SOVEREIGN™ Spinal System

# August 2021

| Submitter: | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Raphael McInnis<br>Sr. Regulatory Affairs Manager<br>Direct Telephone: [phone] |
| Date Prepared | August 6, 2021 |
| Name of Device | SOVEREIGN™ Spinal System |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral Body Fusion Device: 21 CFR 888.3080 |
| Classification | Class II |
| Product Codes | OVD 21 CFR 888.3080 |
| Predicate Devices | There are 9 Predicates.<br><b>Primary Predicate 1</b> - SOVEREIGN™ Spinal System (K091813,<br>S.E 11/17/2009)<br><b>Predicate 2</b> - DIVERGENCE-L™ Anterior/Oblique Lumbar<br>Fusion System (K150135, S.E. 06/11/2015)<br><b>Predicate 3</b> - BASE Interfixated Titanium System (K170592, S.E<br>04/26/2017)<br><b>Predicate 4</b> - CLYDESDALE™ PTC Spinal System (K133205,<br>S.E. 03/13/2014)<br><b>Predicate 5</b> - SOVEREIGN™ Spinal System (K162680, S.E.<br>12/14/2016)<br><b>Predicate 6</b> - DIVERGENCE-L™ Anterior/Oblique Lumbar<br>Fusion System (K162212. S.E. 05/19/2017) |
| | |
| | Predicate 7- CLYDESDALE™ Spinal System (K132897 S.E. 12/11/2013) |
| | Predicate 8- LT-CAGE™ PEEK Lumbar Tapered Fusion Device (P970015, 05/14/1999)* |
| | Predicate 9- SOVEREIGN™ Spinal System (K122037, S.E. 03/22/2013) |
| | * The LT-CAGE™ PEEK Lumbar Tapered Fusion Device falls within the category of a Class II (Special Controls) Cervical Interbody Fusion Device due to the FDA down classification of cages from a Class III device to a Class II¹. The predicate device is a cage/interbody device used for anterior cervical interbody fusion procedures. The predicate components have been tested and found to be substantially equivalent to previously approved cages such as the AFFINITY® Anterior Cervical Cage (titanium), the PEEK PREVAIL™ Cervical Interbody Device and the BAK/C® Cervical Interbody Fusion System. [1] Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Document issued on: June 12, 2007. The predicates have not been subject to a design related recall. |
| Description of Devices | The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The subject devices in this submission add additional polyetheretherketone (PEEK) implant lordosis options with corresponding trials and PTC implant options with a Commercially Pure Titanium (CP Ti) coating, to the existing SOVEREIGN™ Spinal System. SOVEREIGN™ Spinal System |
| Indications for Use | The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft 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 |
| Comparison of<br>Technological<br>Characteristics with the<br>Predicate Devices | variety of open or minimally invasive approaches. These<br>approaches include anterior and oblique. |
| | The SOVEREIGN™ interbody system may be used as a stand-<br>alone device or in conjunction with supplemental fixation. |
| | When used as a stand-alone device, the SOVEREIGN™ interbody<br>device is intended to be used with 3 titanium alloy fixed or<br>variable angle screws. The accompanying cover plate MUST be<br>used anytime the device is used with any number of variable angle<br>screws. If the physician chooses to use less than 3 or none of the<br>provided screws, additional supplemental fixation in the lumbar<br>spine must be used to augment stability. Implants with lordosis<br>angles greater than 18° are intended to be used with supplemental<br>fixation (e.g. facet screws or posterior fixation). |
| | SOVEREIGN™ Spinal System Implants |
| | The primary predicate for the SOVEREIGN™ Spinal System is<br>the predicate SOVEREIGN™ Spinal System (K091813, S.E<br>11/17/2009). The subject SOVEREIGN™ Spinal System devices<br>have identical intended use and similar indications and similar<br>materials as the following FDA cleared Primary Predicate 1<br>K091813 (S.E 11/17/2009), Predicate 2 K150135 (S.E.<br>06/11/2015), Predicate 3 K170592 (S.E. 04/26/2017), Predicate 6<br>K162212 (S.E. 05/19/2017), Predicate 7 K132897 (S.E.<br>12/11/2013), Predicate 8 P970015 (05/14/1999), and Predicate 9<br>K122037 (S.E. 03/22/2013). The predicate and subject devices<br>have the identical function and similar scientific fundamental<br>technology. |
| | SOVEREIGN™ PTC Spinal System Implants |
| | The primary predicate for the SOVEREIGN™ Spinal System is<br>the predicate SOVEREIGN™ Spinal System (K091813, S.E<br>11/17/2009). The subject SOVEREIGN™ Spinal System devices<br>have identical intended use and similar indications and similar<br>materials as the following FDA cleared Primary Predicate 1<br>K091813 (S.E 11/17/2009), Predicate 2 K150135 (S.E.<br>06/11/2015), Predicate 3 K170592 (S.E. 04/26/2017), Predicate 4<br>K133205 (S.E. 03/13/2014), Predicate 6 K162212 (S.E.<br>05/19/2017), Predicate 7 K132897 (S.E. 12/11/2013), Predicate 8<br>P970015 (05/14/1999), and Predicate 9 K122037 (S.E.<br>03/22/2013). The predicate and subject devices have the identical |
| | |
| | SOVEREIGN™ Spinal System Instruments<br>The subject trials are identical in intended use and material as its<br>predicate in Predicate 5 K162680 (S.E 12/14/2016). The<br>difference between the subject and predicate trials is that the<br>subject trials are designed for the sizes of the subject implants. |
| Performance Data | Mechanical Testing<br>In accordance with the Guidance for Industry and FDA Staff -<br>Spinal System 510(k)'s,Medtronic has evaluated the subject<br>devices to demonstrate substantial equivalence to the<br>predicate devices.<br>Design verification testing for the subject implants was completed |
| | in accordance with<br>- ASTM F2077, Test Methods For Intervertebral Body Fusion<br>Devices<br>- ASTM F2267, Standard Test Method for Measuring Load<br>Induced Subsidence of Intervertebral Body Fusion Device Under<br>Static Axial Compression |
| | - ASTM Draft Standard F-04.25.02.02, Static Push-out Test<br>Method for Intervertebral Body Fusion Devices<br>The tests completed were:<br>- Static Compression<br>- Compression Fatigue<br>- Static Compression Shear<br>- Compression Shear Fatigue<br>- Subsidence<br>-Expulsion |
| | The subject implants met the pre-determined acceptance criteria<br>for all tests. Therefore, Medtronic believes design verification<br>testing demonstrated that the subject implants are substantially<br>equivalent to the predicate Medtronic devices. |
| | Medtronic believes that testing is not warranted for the subject<br>instruments as they do not present a new worst case when<br>compared to the predicate devices. |
| | <b>MRI Testing</b> |
| | In accordance with the Guidance for Industry and FDA Staff –<br>Establishing Safety and Compatibility of Passive Implants in the<br>Magnetic Resonance (MR) Environment, Medtronic has evaluated<br>the subject devices to demonstrate substantial equivalence to the<br>predicate devices. Medtronic believes that the subject instruments<br>do not present a new worst case and thus, can justifiably be<br>classified as MR-Conditional. |
| | Based on the test results and additional supporting information<br>provided in this premarket notification, Medtronic believes the<br>subject devices are at least as safe as and effective as the legally<br>marketed predicate devices: |
| | Primary Predicate 1- SOVEREIGNTM Spinal System<br>(K091813, S.E 11/17/2009) Predicate 2- DIVERGENCE-LTM Anterior/Oblique<br>Lumbar Fusion System (K150135, S.E. 06/11/2015) Predicate 3- BASE Interfixated Titanium System<br>(K170592, S.E 04/26/2017) Predicate 4- CLYDESDALETM PTC Spinal System<br>(K133205, S.E. 03/13/2014) Predicate 5- SOVEREIGNTM Spinal System (K162680,<br>S.E. 12/14/2016) Predicate 6- DIVERGENCE-LTM Anterior/Oblique<br>Lumbar Fusion System (K162212, S.E. 05/19/2017) Predicate 7- CLYDESDALETM Spinal System (K132897<br>S.E. 12/11/2013) Predicate 8- LT-CAGETM PEEK Lumbar Tapered Fusion<br>Device (P970015, 05/14/1999) Predicate 9- SOVEREIGNTM Spinal System (K122037,<br>S.E. 03/22/2013) |
| Conclusion | |

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------