CAPSTONE Spinal System, CLYDESDALE Spinal System
Device Facts
| Record ID | K151128 |
|---|---|
| Device Name | CAPSTONE Spinal System, CLYDESDALE Spinal System |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product Code | MAX · Orthopedic |
| Decision Date | Aug 6, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K151128 · Aug 6, 2015 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA, Inc. | Published retrospective clinical literature | The sponsor utilized published retrospective clinical data to demonstrate that the use of allogenic bone graft in interbody fusion procedures for the specified patient population poses no new risks, supporting the expansion of indications for the CLYDESDALE and CAPSTONE systems. | Retrospective clinical data; Allogenic bone graft; Lumbar interbody fusion; Literature review |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Published retrospective clinical data for lumbar interbody fusion devices; Retrospective clinical study | Patients undergoing lumbar interbody fusion procedures | Not applicable for this study | Clinical outcomes and safety of allogenic bone graft usage |
Indications for Use
The CAPSTONE® 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® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE® 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® 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 approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. The CLYDESDALE® Spinal System is intended to be used in interbody 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 CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CLYDESDALE® 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 CLYDESDALE® 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 a minimally invasive lateral approach.
Device Story
Spinal fusion implants (cages) designed for lumbar/lumbosacral interbody fusion; used to provide structural support and correction during surgery. Implants feature hollow geometry to hold autograft or allogenic bone graft (cancellous/corticocancellous). CAPSTONE® system uses PEEK, titanium alloy, or titanium; CLYDESDALE® system uses PEEK. Implants placed via open, minimally invasive posterior, anterior, or transforaminal approaches (CAPSTONE) or minimally invasive lateral approach (CLYDESDALE). Used by surgeons in clinical settings as adjunct to supplemental fixation systems. Benefit: provides stability and facilitates fusion in patients with DDD or degenerative scoliosis.
Clinical Evidence
No new clinical testing performed. Evidence consists of published retrospective clinical data for similar lumbar interbody fusion devices, demonstrating that the use of allogenic bone graft in the specified patient population is safe and effective.
Technological Characteristics
Interbody fusion cages made of PEEK, titanium alloy, or titanium. Hollow geometry for bone graft packing. No design changes from predicate devices. Manual surgical instrumentation used for placement.
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
Reference Devices
- ANATOMIC™ PEEK Cervical Fusion System (K130177)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132
Re: K151128
Trade/Device Name: CLYDESDALE® Spinal System and CAPSTONE® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 30, 2015 Received: July 8, 2015
August 6, 2015
Dear Mr. Grant:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Lee Grant
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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| | Indications for Use |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| K151128 | Page 1 of 2 |
| 510(k) Number (if known) | K151128 |
| Device Name | CAPSTONE® Spinal System |
| Indications for Use (Describe) | |
| The CAPSTONE® 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® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | |
| Additionally, the CAPSTONE® 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® 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 approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. | |
| Type of Use (Select one or both, as applicable) | |
| | <div> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |
| 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." | |
| FORM FDA 3881 (8/14) | Page 1 of 1 |
| PSC Publishing Services (301) 443-6740 | EF |
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| <b>Indications for Use</b> |
| Form Approved: OMB No. | 0910-0120 |
|--------------------------|------------------|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. | |
| K151128 | |
| Page | 2 of 2 |
| 510(k) Number ( <i>if known</i> ) | K151128 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Device Name | CLYDESDALE® Spinal System |
| Indications for Use (Describe) | |
| The CLYDESDALE® Spinal System is intended to be used in interbody 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 CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | |
| Additionally, the CLYDESDALE® 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 CLYDESDALE® 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 a minimally invasive lateral approach. | |
| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------|
| <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|-------------------------------------------|-------------|
| PSC Publishing Services (301) 443-6740 EF | |
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## 510(k) Summary - K151128
## August 2015
| Company: | Medtronic Sofamor Danek USA<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: (901) 396-3133<br>Fax: (901) 346-9738 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lee Grant<br>Distinguished Regulatory Affairs Advisor |
| Common Name: | Lumbar interbody fusion device, interbody cage |
| Device Trade Name: | (1) CLYDESDALE® Spinal System; (2) CAPSTONE® Spinal<br>System |
| Regulatory Class: | II |
| Regulation Number: | 21CFR Section 888.3080 |
| Classification Name(s): | Intervertebral Body Fusion Device |
| Product Code: | MAX |
| Predicate Devices: | Primary Predicate: CLYDESDALE® Spinal System (K133577,<br>SE 09/26/14) Class II, 21 CFR 888.3080, MAX; Additional<br>Predicate: CAPSTONE® Spinal System (K133650, SE<br>12/20/13) Class II, 21 CFR 888.3080, MAX |
Description:
CLYDESDALE® Spinal System: The CLYDESDALE® Spinal System consists of PEEK 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 graft. The purpose of this 510(k) submission is to expand the indications of the CLYDESDALE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.
CAPSTONE® Spinal System: The CAPSTONE® Spinal System consists of PEEK cages, titanium alloy cages and titanium 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
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autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CAPSTONE® Spinal System includes various instruments, including trials used to assist in placement of the implants. The purpose of this 510(k) submission is to expand the indications of the CAPSTONE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.
## Indications for Use:
## CLYDESDALE® Spinal System:
The CLYDESDALE® Spinal System is intended to be used in interbody 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 CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the CLYDESDALE® 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 CLYDESDALE® 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 a minimally invasive lateral approach.
CAPSTONE® Spinal System: The CAPSTONE® 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® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
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Additionally, the CAPSTONE® 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® 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 approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach.
Summary of the Technological Characteristics: The purpose of this bundled 510(k) application is to allow for the usage of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be allowed as a graft material option for these devices. All subject devices found within this bundled submission have the same fundamental scientific technology. They are intended to provide correction and stabilization during intervertebral body fusion procedures for the aforementioned indications. They are all manufactured from the same materials as their respective predicates and there have been no changes to the implants' designs. With the exception of the inclusion of the allogenic bone graft material option, there have been no changes to either system's offerings and they are therefore substantially equivalent to their predicates.
Identification of Legally Marketed Devices: The subject CLYDESDALE® Spinal System is identical in design to the CLYDESDALE® Spinal System cleared in K133577 (SE 09/26/14), the primary predicate for this set of implants. No new CLYDESDALE® Spinal System implants are contained in this application. The subject CAPSTONE® Spinal System implants included in this application are identical in design to the CAPSTONE® Spinal System implants cleared in K133650 (SE 12/20/13). The aforementioned K133650 CAPSTONE® Spinal System application serves as an additional predicate for the implants contained in this application. No new CAPSTONE® Spinal System implants are included in this application.
Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Published retrospective clinical data for the lumbar interbody fusion devices similar to the CLYDESDALE® Spinal System and the CAPSTONE® Spinal System were provided in support of this application. The published clinical outcomes demonstrated that the use of allogenic bone graft in interbody fusion procedures to treat the patient population referenced in the indications statement, poses no new risks to the patients. No changes were made to the existing devices, nor
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were any new components added to the systems. Therefore, no additional testing was required or performed. This submission also referenced the ANATOMIC™ PEEK Cervical Fusion System (K130177), as it was recently cleared by the FDA for usage with allogenic bone graft.
Conclusion: The subject CLYDESDALE® Spinal System and the CAPSTONE® Spinal System are substantially equivalent to the primary predicate devices cleared in K133577 for the CLYDESDALE® Spinal System and in the additional predicate, K133650 application, for the CAPSTONE® Spinal System. The published clinical outcomes demonstrate these devices may be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
