(57 days)
Not Found
No
The document describes physical implants and surgical procedures, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an intervertebral body fusion device used for cervical interbody fusion procedures to treat cervical disc disease, indicating its direct role in treating a medical condition.
No
Explanation: The device described is an implantable medical device used for cervical interbody fusion procedures. It is a treatment device, not a diagnostic one. While its indication for use mentions that the patient's condition is "confirmed by radiographic studies," the device itself does not perform any diagnostic function.
No
The device description clearly states that the devices are physical implants made from materials like PEEK and titanium alloy, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The descriptions clearly state that these devices are implants (cages, spacers, interbody devices) designed to be surgically inserted into the cervical spine to provide support and promote fusion.
- Intended Use: The intended use is for cervical interbody fusion procedures in patients with cervical disc disease. This is a surgical treatment, not a diagnostic test performed on a specimen.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens with these devices.
Therefore, these devices fall under the category of surgical implants or devices used in surgical procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft and is to be implanted via an open, anterior approach.
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in sketally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical discase is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation and implanted via an open, anterior approach.
The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL® Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL® Cervical Interbody Device implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
CORNERSTONE® PSR Cervical Fusion System
The CORNERSTONE® PSR Cervical Fusion System consists of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical 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 graft in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation, and is to be implanted via an open, anterior approach.
The CORNERSTONE® PSR devices are manufactured from medical grade polyetheretherketone (PEEK) material with tantalum or titanium alloy (Ti-6Al-4V) pin markers. The PEEK material used in the subject interbody cage conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical Implant Applications", the titanium alloy material used conforms to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)" and the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications".
PERIMETER® C Spinal System
The PERIMETER® C Spinal System consists of spacers of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. 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 graft and is to be used with supplemental fixation in all procedures. PERIMETER® C Spinal System is used with instrumentation that enables the surgeon to implant the devices via an open, anterior approach.
The subject PERIMETER® C devices are manufactured from medical grade titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK) material with tantalum pin markers. The PEEK material used in the subject interbody cage conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical Implant Applications", the titanium alloy material used conforms to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)" and the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications".
PEEK PREVAIL® Cervical Interbody Device
The PEEK PREVAIL® Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a two screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The subject PEEK PREVAIL® Cervical Interbody device implant is manufactured from medical grade polyetheretherketone (PEEK) material and contains tantalum radiopaque markers. The subject device also contains a Nitinol screw locking mechanism and uses bone screws made of grade titanium alloy (Ti-6Al-4V). The PEEK material used in the subject interbody cage conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical Implant Applications", the titanium alloy material used for bone screws conforms to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)", the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications" and the Nitinol material used conforms to ASTM F2063 "Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Cervical spine, from the C2-C3 disc to the C7-T1 disc
Indicated Patient Age Range
skeletally mature patients
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 cervical interbody fusion devices were provided in support of this application. The clinical data demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above poses no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ANATOMIC PEEK Cervical Fusion System (K130177), CORNERSTONE® PSR Cervical Fusion System (K111264), PERIMETER® C Spinal System (K100967, K132584), PEEK PREVAIL® Cervical Interbody Devices (K073285, K094042)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
Medtronic Sofamor Danek Sneh Pingle Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K153373
Trade/Device Name: CORNERSTONE® PSR Cervical Fusion System, PERIMETER® C Spinal System, PEEK PREVAIL® Cervical Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, OVE Dated: November 20, 2015 Received: November 23, 2015
Dear Sneh Pingle:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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.
Page 1 of 3
510(k) Number (if known)
K153373
Device Name
CORNERSTONE® PSR Cervical Fusion System
Indications for Use (Describe)
The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft and is to be implanted via an open, anterior approach.
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
"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."
3
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.
Page 2 of 3
510(k) Number (if known)
Device Name PERIMETER® C Spinal System
Indications for Use (Describe)
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in sketally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical discase is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation and implanted via an open, anterior approach.
| 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
"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
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.
Page 3 of 3
510(k) Number (if known)
Device Name
PEEK PREVAIL® Cervical Interbody Device
Indications for Use (Describe)
The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL® Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL® Cervical Interbody Device implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
| 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
CervicalAntacteritySpacenotidorAllagrafisponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
5
510(k) Summary
Medtronic Sofamor Danek
CORNERSTONE® PSR Cervical Fusion System, PEEK PREVAIL® Cervical Interbody Device and PERIMETER® C Spinal System
I. SUBMITTER
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact Person: Sneh Pingle, Regulatory Affairs Specialist Date Prepared: 14 January 2016
II. DEVICE
Name of Devices: CORNERSTONE® PSR Cervical Fusion System PERIMETER® C Spinal System PEEK PREVAIL® Cervical Interbody Device Common or Usual Name: Cervical Intervertebral Fusion Device
Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080)
Regulatory Class: II
Product Code: ODP, OVE
PREDICATE DEVICE III.
Primary Predicate:
- . ANATOMIC PEEK Cervical Fusion System (K130177, SE 09/23/2013)
Additional Predicate Devices:
- CORNERSTONE® PSR Cervical Fusion System (K111264, SE 10/12/2011) ●
- PERIMETER® C Spinal System (K100967, SE 08/05/2011; K132584, SE ● 12/04/2013)
- PEEK PREVAIL® Cervical Interbody Devices (K073285, SE 05/15/2008; ● K094042, SE 06/30/2010)
6
IV. DEVICE DESCRIPTION
CORNERSTONE® PSR Cervical Fusion System
The CORNERSTONE® PSR Cervical Fusion System consists of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical 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 graft in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation, and is to be implanted via an open, anterior approach.
The CORNERSTONE® PSR devices are manufactured from medical grade polyetheretherketone (PEEK) material with tantalum or titanium alloy (Ti-6Al-4V) pin markers. The PEEK material used in the subject interbody cage conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical Implant Applications", the titanium alloy material used conforms to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)" and the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications".
PERIMETER® C Spinal System
The PERIMETER® C Spinal System consists of spacers of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous
7
and/or corticocancellous bone graft and is to be used with supplemental fixation in all procedures. PERIMETER® C Spinal System is used with instrumentation that enables the surgeon to implant the devices via an open, anterior approach.
The subject PERIMETER® C devices are manufactured from medical grade titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK) material with tantalum pin markers. The PEEK material used in the subject interbody cage conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical Implant Applications", the titanium alloy material used conforms to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)" and the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications".
PEEK PREVAIL® Cervical Interbody Device
The PEEK PREVAIL® Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a two screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The subject PEEK PREVAIL® Cervical Interbody device implant is manufactured from medical grade polyetheretherketone (PEEK) material and contains tantalum radiopaque markers. The subject device also contains a Nitinol screw locking mechanism and uses bone screws made of grade titanium alloy (Ti-6Al-4V). The PEEK material used in the subject interbody cage conforms to ASTM F2026 "Standard Specification for polyetheretherketone (PEEK) Polymers for Surgical
8
Implant Applications", the titanium alloy material used for bone screws conforms to ASTM F136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)", the tantalum material used conforms to ASTM F560 "Standard Specification for Unalloyed Tantalum for Surgical Implant Applications" and the Nitinol material used conforms to ASTM F2063 "Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants".
INDICATIONS FOR USE V.
CORNERSTONE® PSR Cervical Fusion System
The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.
PERIMETER® C Spinal System
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of nonoperative treatment. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and/or allogenic bone graft
9
comprised of cancellous and/or corticocancellous bone graft and supplemental fixation and implanted via an open, anterior approach.
PEEK PREVAIL® Cervical Interbody Device
The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL® Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL® Cervical Interbody Device implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. WITH THE PREDICATE DEVICE
The technological principle for both the subject and predicate devices is cervical interbody fusion to provide correction and stabilization during intervertebral body fusion procedures. The subject devices are all manufactured from the same materials noted in the previously cleared predicate and referenced devices. Both the subject and predicate devices operate on the usage of PEEK/ Titanium Alloy cages inserted into the disc space along with graft material to facilitate fusion at single or multiple levels in the cervical spine. The predicate and subject devices consist of both interbody cages which include internal fixation screws and interbody cages which must be used with supplemental fixation. Both the subject and predicate devices are surgically implanted via an anterior approach for the same patient population. The purpose of this 510(k) bundled submission is to expand the indications to allow these interbody cages to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as a graft material option. With the exception of the
10
inclusion of allograft to the modified indications, there have been no changes to subject systems, and they are therefore substantially equivalent to the predicate ANATOMIC PEEK.
DISCUSSION OF SUPPORTING RETROSPECTIVE CLINICAL DATA AND VII. NON-CLINICAL TESTING
Published retrospective clinical data for the cervical interbody fusion devices were provided in support of this application. The clinical data demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above poses no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.
VIII. CONCLUSIONS
The design features, materials used, manufacturing and sterilization methods are equivalent to the previously cleared CORNERSTONE® PSR, PEEK PREVAIL®, and PERIMETER® C cervical fusion system components with the exception of broadening the indications to include the aforementioned use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative graft material. The expanded indications sought in this application are identical to those granted to the ANATOMIC PEEK Spinal System in K130177 (SE 09/23/2013).