(60 days)
K151128, S.E. 08/06/2015
No
The document describes physical spinal implants and their intended use, materials, and dimensions. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is an implantable interbody fusion device used to treat degenerative disc disease and provide support and correction during lumbar intervertebral body fusion, which directly addresses a medical condition.
No.
The device is an expandable interbody fusion device, indicated for interbody fusion in patients with degenerative disc disease. Its purpose is to provide support and correction during lumbar intervertebral body fusion, not to diagnose a condition.
No
The device description clearly outlines physical implants made of PEEK and Titanium Alloy, which are hardware components. The intended use also describes surgical implantation of these physical devices.
Based on the provided information, these devices are not In Vitro Diagnostics (IVDs).
Here's why:
- IVDs analyze samples from the human body. The intended use and device descriptions clearly state that these are implants designed for surgical insertion into the lumbar spine for interbody fusion. They are physical devices used in the body, not for testing samples from the body.
- The purpose is structural support and fusion. The devices are intended to provide support, correction, and facilitate bone fusion between vertebrae. This is a therapeutic intervention, not a diagnostic test.
- The "Input Imaging Modality" is for visualization during surgery. Radiographic visualization is mentioned, but this is for guiding the surgical procedure and confirming placement, not for analyzing biological samples to diagnose a condition.
Therefore, these devices fall under the category of implantable medical devices for orthopedic surgery, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.
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. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplementation which has been cleared by the FDA for use in the lumbar spine.
The CRESCENT™ Spinal System Titanium is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
ELEVATE™ Spinal System
The subject ELEVATE™ Spinal System consists of bullet nose expandable cages with teeth. The top of the cage is made of Polyetheretherketone (PEEK) and the base is made of Titanium Alloy (Ti-6Al-4V). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The ELEVATE™ implants are provided in both standard and an extra-lordotic design. The devices can be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The implants also contain hollow geometry which allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
CAPSTONE PTC™ Spinal System
The subject CAPSTONE PTC™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and coated with Commercially Pure Titanium (CP Ti). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CAPSTONE PTC™ implants are provided in 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 autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
CRESCENT™ Spinal System
The subject CRESCENT™ Spinal System consists of banana shaped cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CRESCENT™ implants are provided in 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 autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
CRESCENT® Spinal System Titanium
The subject CRESCENT™ Spinal System Titanium consists of banana shaped cages with a bullet nose and angular teeth. The CRESCENT™ Titanium implants are made of Titanium Alloy (Ti-6Al-4V) and are provided in 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 autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Lumbar or lumbosacral vertebral bodies (L2 to S1)
Indicated Patient Age Range
Skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Published retrospective clinical data for the lumbar interbody fusion devices was cleared by the FDA in Medtronic's CAPSTONE® and CLYDESDALE® Spinal System (K151128, S.E. 08/06/2015). The retrospective clinical data demonstrated that the use of allogenic bone graft in combination with, or without, autogenous bone graft is commonly used in conjuntion with interbody fusion devices and poses no new risks to patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151128, K142559, K133205, K094025, K110543
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
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.(b)
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2017
Medtronic Sofamor Danek Mr. Justin O'Connor Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K172199
Trade/Device Name: ELEVATE™ Spinal System, CAPSTONE PTC™ Spinal System, CRESCENT™ Spinal System, CRESCENT™ Spinal System Titanium Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 20, 2017 Received: July 21, 2017
Dear Mr. O'Connor:
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
510(k) Number (if known)
Device Name ELEVATE™ Spinal System
Indications for Use (Describe)
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
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
3
510(k) Number (if known)
Device Name CAPSTONE PTC™ Spinal System
Indications for Use (Describe)
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.
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. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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
4
510(k) Number (if known)
K172199 Device Name CRESCENTTM Spinal System
Indications for Use (Describe)
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplementation which has been cleared by the FDA for use in the lumbar spine.
X Prescription Use (Part 21 CFR 801 Subpart D)
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
5
510(k) Number (if known)
K172199
Device Name CRESCENT™ Spinal System Titanium
Indications for Use (Describe)
The CRESCENT™ Spinal System Titanium is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
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
6
510(k) SUMMARY
MEDTRONIC Sofamor Danek
ELEVATE™ Spinal System, CAPSTONE PTC™ Spinal System, CRESCENT™ Spinal System, and CRESCENT™ Spinal System Titanium
July 2017
| I. | Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133 |
|-----|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Justin E. O'Connor
Regulatory Affairs Specialist |
| | Date Prepared: | July 20, 2017 |
| II. | Subject Device | |
| | Name of Device: | ELEVATE™ Spinal System, CAPSTONE PTC™
Spinal System, CRESCENT™ Spinal System,
and CRESCENT™ Spinal System Titanium |
| | Regulation Number: | 888.3080 |
| | Code: | MAX |
| | Classification Name: | Intervertebral Fusion Device with Bone Graft,
Lumbar |
| | Classification: | Class II |
| | Common Name: | Intervertebral Body Fusion Device |
7
III. Predicate Device:
K151128 (S.E. 08/06/2015) CAPSTONE® and CLYDESDALE® Spinal Systems - Predicate 1, Primary Predicate
K142559 (S.E. 06/09/2015) ELEVATE™ Spinal System - Predicate 2, Additional Predicate
K133205 (S.E. 03/13/2014) CAPSTONE PTCTM and CLYDESDALE PTCTM Spinal Systems -Predicate 3, Additional Predicate
K094025 (S.E. 04/26/2010) CRESCENTTM Spinal System – Predicate 4, Additional Predicate
K110543 (S.E. 08/09/2011) CRESCENTTM Spinal System Titanium - Predicate 5, Additional Predicate
The predicates have not been subject to a design related recall.
IV. Device Description:
ELEVATE™ Spinal System
The subject ELEVATE™ Spinal System consists of bullet nose expandable cages with teeth. The top of the cage is made of Polyetheretherketone (PEEK) and the base is made of Titanium Alloy (Ti-6Al-4V). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The ELEVATE™ implants are provided in both standard and an extra-lordotic design. The devices can be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The implants also contain hollow geometry which allows them to be packed with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
8
CAPSTONE PTC™ Spinal System
The subject CAPSTONE PTC™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and coated with Commercially Pure Titanium (CP Ti). The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CAPSTONE PTC™ implants are provided in 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 autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
CRESCENT™ Spinal System
The subject CRESCENT™ Spinal System consists of banana shaped cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone (PEEK) and contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The CRESCENT™ implants are provided in 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 autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
CRESCENT® Spinal System Titanium
The subject CRESCENT™ Spinal System Titanium consists of banana shaped cages with a bullet nose and angular teeth. The CRESCENT™ Titanium implants are made of Titanium Alloy (Ti-6Al-4V) and are provided in 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 autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
9
V. Indications:
ELEVATE™ Spinal System
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
CAPSTONE PTC™ Spinal System
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. 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. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
10
CRESCENT™ Spinal System
The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
CRESCENT™ Spinal System Titanium
The CRESCENT™ Spinal System Titanium is indicated for interbody fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
VI. Comparison of Technological Characteristics with the Predicate Devices:
The technological principle for both the subject and predicate devices is lumbar interbody fusion to provide correction and stabilization during intervertebral body fusion procedures. The subject interbody cages are all manufactured from the same materials as their system predicates and are inserted into the disc space along with graft material to
11
facilitate fusion, using supplemental fixation, at one or two contiguous levels from L2-S1.
The subject and predicate interbody cages are sterilized via gamma irradiation and provided sterile to the end user. In order to satisfy the FDA Endotoxin requirements for this submission, a bacterial endotoxin test. also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP , Transfusion and Infusion Assemblies and Similar Medical Devices.
The purpose of this 510(k) bundled submission is to expand the indications to allow the subject interbody cages to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone as an alternative graft material option. With the exception of the inclusion of allogenic bone graft to the modified indications, there have been no changes to subject interbody cages; therefore, they are substantially equivalent to their predicates.
Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: VII.
Published retrospective clinical data for the lumbar interbody fusion devices was cleared by the FDA in Medtronic's CAPSTONE® and CLYDESDALE® Spinal System (K151128, S.E. 08/06/2015). The retrospective clinical data demonstrated that the use of allogenic bone graft in combination with, or without, autogenous bone graft is commonly used in conjuntion with interbody fusion devices and poses no new risks to patients. Because the subject devices have the same intended use, indications, and fundamental technology as the primary predicate devices, the retrospective clincal data cleared in K151128 still applies, and no additional clinical data is required as a result of this submission.
12
VIII. Conclusion:
The design features, materials used, manufacturing processes, and sterilization methods are equivalent to the cleared ELEVATE™, CAPSTONE PTC™, CRESCENT™, and CRESCENT™ Titanium devices, with the exception of expanding the indications to include the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone as an alternative graft material option. The expanded indications sought after in this application are identical to those cleared in K151128 (S.E. 08/06/2015).