CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System

K171107 · Medtronic Sofamor Danek USA, Inc. · MAX · Sep 26, 2017 · Orthopedic

Device Facts

• Record ID: K171107
• Device Name: CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAPSTONE CONTROL™ System, including the CAPSTONE CONTROL PTC™ Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally. the CAPSTONE CONTROL™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

Device Story

Interbody fusion system consisting of PEEK cages with tantalum markers and optional commercially pure titanium (CP Ti) coating; designed for lumbar/lumbosacral interbody fusion. Implants inserted between vertebral bodies to provide support/correction; hollow geometry packed with autograft/allogenic bone graft. Used in spinal fusion procedures via open or minimally invasive posterior/transforaminal approaches. Operated by surgeons; requires supplemental fixation. Provides anterior column support; facilitates fusion in DDD and degenerative scoliosis patients. Benefits include structural support and correction of disc space height.

Clinical Evidence

Bench testing only. Mechanical testing included static/fatigue compression and compression-shear, subsidence, expulsion, and wear debris. Coating evaluation performed per ASTM standards. Cadaver validation labs confirmed surgical usability and instrument/implant function. MRI safety evaluated via comparison to worst-case passive implant systems.

Technological Characteristics

Interbody fusion cages; materials: PEEK, tantalum markers, commercially pure titanium (CP Ti) coating. Dimensions: 8-18mm height, 22-32mm length, 9-10mm width; 0-24 degree lordosis. Mechanical testing per ASTM F2077, F2267, F1877. Coating testing per ASTM F1854, F1160, F1044, F1147; EN ISO 3274, 4287, 4288. Passive implant.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels (L2-S1), including those with up to Grade 1 Spondylolisthesis or retrolisthesis, who have failed six months of nonoperative treatment. Also indicated for anterior column support in degenerative scoliosis as an adjunct to pedicle screw fixation.

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

• CAPSTONE® Spinal System (K151128)
• CAPSTONE® Spinal System (K073291)
• CAPSTONE CONTROL™ Spinal System (K120368)
• CAPSTONE PTC™ Spinal System (K133205)
• DIVERGENCE-L™ Spinal System (K150135)
• SOVEREIGN® Spinal System (K122037)

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 26, 2017

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek USA, Inc. Raphael McInnis Manager, Regulatory Affairs 1800 Pvramid Place Memphis. Tennessee 38132

Re: K171107

Trade/Device Name: CAPSTONE CONTROL™ Spinal System CAPSTONE CONTROL PTC™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 11, 2017 Received: September 13, 2017

Dear Mr. McInnis:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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/MedicalDevices/ResourcesforYou/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

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## Indications for Use

510(k) Number (if known) K171107

Device Name CAPSTONE CONTROL™ SPINAL SYSTEM CAPSTONE CONTROL PTC™ Spinal System

### Indications for Use (Describe)

The CAPSTONE CONTROL™ System, including the CAPSTONE CONTROL PTC™ Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally. the CAPSTONE CONTROL™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

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

| <div style="display:flex; align-items:center;"><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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## 510(k) Summary

# MEDTRONIC Sofamor Danek CAPSTONE CONTROL™ SPINAL SYSTEM September 2017

# Submitter: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: [phone] Fax: [phone] Contact: Raphael McInnis Regulatory Affairs Sr. Manager Telephone: [phone] (Direct)

Alternate Contact: Julie Bassett Regulatory Affairs Program Manager Telephone: [phone] (Direct)

- Date Prepared: September 25, 2017
#### II. Device:

I.

| Name of Device: | CAPSTONE CONTROL™ Spinal System<br>CAPSTONE CONTROL PTC™ Spinal System |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Interbody cage, interbody fusion device |
| Classification Name: | Intervertebral Body Fusion Device with bone graft<br>(21 CFR 888.3080) |
| Class: | II |
| Product Code: | MAX |

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#### III. Predicate Devices:

CAPSTONE® Spinal System Primary Predicate - K151128, SE 8/5/2015 CAPSTONE® Spinal System Predicate #2 - K073291, SE 4/24/2008 CAPSTONE CONTROL™ Spinal System Predicate #3 - K120368, SE 4/9/2012 CAPSTONE PTCTM Spinal System Predicate #4 - K133205, SE 3/13/2014 DIVERGENCE-LTM Spinal System Predicate #5 - K150135, SE 6/11/2015 SOVEREIGN® Spinal System Predicate #6 - K122037, SE 3/22/2013

The predicates have not been subject to a design related recall.

#### IV. Description of Devices

The subject CAPSTONE CONTROL™ Spinal System adds 24-degree lordotic PEEK cages with tantalum markers to the existing CAPSTONE CONTROLTM Spinal System. Both the predicate sizes, and including the subject 24-degree lordotic cages, will also be provided with a commercially pure titanium coating (CP Ti) on the opposing, endplate-contacting sides of the implant. The titanium coated interbody cages will be branded as the CAPSTONE CONTROL PTC™ Spinal System (PTC = Pure Titanium Coating) to differentiate the coated cages from the uncoated CAPSTONE CONTROLTM Spinal System cages. The titanium coating is identical to the coating on the predicate CAPSTONE PTC™ Spinal System implants (Predicate #4).

The subject instruments include 24-degree lordotic cam spreader trials that correspond to the subject 24-degree lordotic cages. The predicate and subject cam spreader trials, and other instruments used to facilitate the implantation of the uncoated CAPSTONE CONTROL™ Spinal System cages, will also be used with the CAPSTONE CONTROL PTC™ Spinal System.

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The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems consist of interbody fusion cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.

The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal System cages are available in heights of 8mm to 18mm, lengths of 22mm, 27mm, and 32mm, and widths of 9mm or 10mm. The implants will be available with 0°, 6°, 12°, 18°, or 24° of lordosis. The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems also include cam spreader trials and a variety of instruments to help facilitate the implantation of the interbody fusion cages.

#### V. Indications for Use:

The indications for use for the CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ are identical to the indications for use cleared for the primary predicate, CAPSTONE® Spinal System in K151128 (SE 8/5/2015). The indications for use are as follows:

The CAPSTONE CONTROL™ Spinal System, including the CAPSTONE CONTROL PTCTM Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

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Additionally, the CAPSTONE CONTROL™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROLTM Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

#### VI. Comparison of Technological Characteristics with the Predicate Devices:

The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems' interbody cages and cam spreader trials have the same intended use, materials, design features, and fundamental technology as their respective predicate devices:

CAPSTONE® Spinal System Primary Predicate - K151128, SE 8/5/2015 CAPSTONE® Spinal System Predicate #2 - K073291, SE 4/24/2008 CAPSTONE CONTROL™ Spinal System Predicate #3 - K120368, SE 4/9/2012 CAPSTONE PTCTM Spinal System Predicate #4 - K133205, SE 3/13/2014 DIVERGENCE-L™ Spinal System Predicate #5 - K150135, SE 6/11/2015 SOVEREIGN® Spinal System Predicate #6 - K122037, SE 3/22/2013

For instance, the subject CAPSTONE CONTROL PTC™ interbody cages have the same overall design as the predicate CAPSTONE CONTROL™ interbody cages. The primary difference is the titanium coating. The predicate and subject interbody cages are intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The cam spreader trials are used to assist the surgeon

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in selecting the appropriate size cage to use for the patient and are available in all the same lengths and lordotic options as the implants.

#### VII. Performance Data:

The following performance data were provided in support of substantial equivalence:

### Commercially Pure Titanium Coating Evaluation

The commercially pure titanium coating used on the subject CAPSTONE CONTROL PTC™ Spinal System implants and CAPSTONE PTC™ Spinal System implants (Predicate #4) were evaluated in accordance with FDA's Guidance for FDA Reviewers/Staff, Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements, issued February 2, 2000, and evaluated in accordance with the following standards:

- . ASTM F1854: Standard test method for stereological evaluation of porous coatings on medical implants;
- ASTM F1160: Standard Test Method for Shear and Bending Fatigue ● Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/ Metallic Coatings;
- ASTM F1044: Standard test method for shear testing of calcium ● phosphate coatings and metallic coatings;
- ASTM F1147: Standard test method for tension testing of calcium phosphate & metallic coatings;
- EN ISO 3274: Geometrical Product Specification (GPS) Surface ● Texture: Profile Method - Nominal Characteristics of Contact (stylus instruments);
- EN ISO 4287: Geometrical Product Specification (GPS) - Surface Texture: Profile Method -Terms, Definitions, and Surface Texture Parameters; and
- EN ISO 4288: Geometrical Product Specification (GPS) Surface ● Texture: Profile Method – Rules and Procedures for the Assessment of Surface Texture.

The predetermined acceptance criteria, established using predicate test data,

were met for all tests.

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### Mechanical Testing

Medtronic has evaluated the subject devices in accordance with FDA's Guidance Document, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, issued June 12, 2007 to demonstrate substantial equivalence to the predicate devices.

Design verification testing was completed on the worst case subject 24-degree lordotic coated CAPSTONE CONTROL PTC™ implants in accordance with:

- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices;
- ASTM F2267: Standard Test Method for Measuring Load Induced ● Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression:
- ASTM Draft Standard F.04.25.02.02: Static Push-out Test Method for ● Invertebral Body Fusion Devices; and
- ASTM F1877: Standard Practice for Characterization of Particles. ●

Design verification testing consisted of the following tests:

- Static Compression ●
- Compression Fatigue ●
- Static Compression-Shear ●
- Compression-Shear Fatigue ●
- Subsidence
- Expulsion ●
- Wear Debris ●

For expulsion (push-out) testing, the subject 24-degree lordotic uncoated CAPSTONE CONTROLTM implants were also tested. The subject 24-degree lordotic CAPSTONE CONTROL PTC™ implants met the pre-determined acceptance criteria, established using predicate test data, for all tests.

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### Design Validation

Cadaver validation labs demonstrated that independent surgeons could insert and rotate the 24-degree implant without issue or failure of the implants or instruments. The cadaver validation labs demonstrated that the subject implants and instruments functioned as intended and user needs were met.

### MRI Safety Evaluation

In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject 24degree lordotic CAPSTONE CONTROLTM interbody cages and the subject CAPSTONE CONTROL PTC™ interbody cages were evaluated using a comparison to a worst-case device for MR-safety that had been tested in accordance with the following standards:

- ASTM F2052: Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment;
- ASTM F2213: Standard test method for measurement of magnetically ● induced torque on medical devices in the magnetic resonance environment:
- ASTM F2119: Standard test method for evaluation of MR image ● artifacts from passive implants: and
- ASTM F2182: Standard test method for measurement of radio frequency ● induced heating on or near passive implant during magnetic resonance imaging.

For purposes of MR safety, the volume of metallic material, types of metallic material, and geometry of the implant were compared to a worst-case spinal system. Based on the performance and MR-Conditional classification of the worst case spinal system, it can be inferred that CAPSTONE CONTROL™ (24degree lordosis) and CAPSTONE CONTROL PTC™ implants will behave in a similar (albeit reduced) manner relative to MRI issues compared to the worstcase system.

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### VIII. Conclusion:

Based on the risk analysis, test results, and additional supporting documentation provided in the pre-market notification, the subject CAPSTONE CONTROL™ Spinal System and CAPSTONE CONTROL PTC™ Spinal System are equivalent to the following predicates:

CAPSTONE® Spinal System Primary Predicate - K151128, SE 8/5/2015 CAPSTONE® Spinal System Predicate #2 - K073291, SE 4/24/2008 CAPSTONE CONTROL™ Spinal System Predicate #3 - K120368, SE 4/9/2012 CAPSTONE PTCTM Spinal System Predicate #4 - K133205, SE 3/13/2014 DIVERGENCE-L™ Spinal System Predicate #5 - K150135, SE 6/11/2015 SOVEREIGN® Spinal System Predicate #6 - K122037, SE 3/22/2013