(161 days)
No
The device description and performance studies focus on the mechanical properties and materials of the implant, with no mention of AI or ML for image analysis, diagnosis, or treatment planning.
Yes
The device is used to treat cervical disc disease by facilitating interbody fusion, which directly addresses a medical condition to restore function and alleviate symptoms.
No
The device description indicates that the CORNERSTONE® PSR Cervical Fusion System consists of spacers inserted between vertebral bodies and instrumentation for implantation, which are used to achieve fusion, not to diagnose a condition. The "Indications for Use" section describes the condition for which the device is used (cervical disc disease confirmed by radiographic studies), but the device itself is a treatment, an implant, not a diagnostic tool.
No
The device description clearly states it consists of physical spacers made from PEEK and containing tantalum or titanium markers, along with surgical instrumentation. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The CORNERSTONE® PSR Cervical device is an implantable medical device used in surgery to provide structural support and promote fusion between cervical vertebrae. It is a physical device inserted into the body, not a device that analyzes biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating cervical disc disease by providing support and promoting fusion, not by analyzing biological samples.
Therefore, based on the provided information, the CORNERSTONE® PSR Cervical device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CORNERSTONE® PSR Cervical 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 autograft.
Product codes
ODP
Device Description
The CORNERSTONE® PSR Cervical Fusion System consists of spacers which can be inserted between two cervical vertebral bodies to give support and correction until fusion occurs. The hollow geometry of the implant allows it to be packed with autogeneous bone graft. The CORNERSTONE® PSR Cervical Fusion System also includes instrumentation that enables the surgeon to implant the devices via an open, anterior approach.
The device sizes are available in various heights and in a 4º lordotic angle option. The implant devices are manufactured from medical grade polyetheretherketone (PEEK -OPTIMA® LT1) per ASTM F2026 and also contain either tantalum markers per ASTM F-560 or titanium alloy markers per ASTM F-136 so that the position of the implant can be determined on X-ray or other imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or other imaging
Anatomical Site
Cervical vertebral bodies (C2-C3 disc to the C7-T1 disc)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Surgeon, clinical setting
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)
The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077-03; subsidence per ASTM F2267-04; and expulsion. The results of these studies were found to be substantially equivalent to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100214, K041197, K093093, K081917
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.
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OCT 1 2 2011
CORNERSTONE® PSR Cervical Fusion System Interbody Fusion Device 510(k) Summary May 2011
I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Regina Holmes Contact: Senior Regulatory Affairs Specialist
II. Proprietary Trade Name: CORNERSTONE® PSR Cervical Fusion System
Classification Name: Intervertebral Body Fusion Device
Product Code: ODP (21 CFR 888.3080)
Common Name: Cervical Interbody Fusion Device
III. Product Description
The CORNERSTONE® PSR Cervical Fusion System consists of spacers which can be inserted between two cervical vertebral bodies to give support and correction until fusion occurs. The hollow geometry of the implant allows it to be packed with autogeneous bone graft. The CORNERSTONE® PSR Cervical Fusion System also includes instrumentation that enables the surgeon to implant the devices via an open, anterior approach.
The device sizes are available in various heights and in a 4º lordotic angle option. The implant devices are manufactured from medical grade polyetheretherketone (PEEK -OPTIMA® LT1) per ASTM F2026 and also contain either tantalum markers per ASTM F-560 or titanium alloy markers per ASTM F-136 so that the position of the implant can be determined on X-ray or other imaging.
IV. Indications for Use
The CORNERSTONE® PSR Cervical 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
1
radiographic studies. This device is to be used in patients who have had six weeks of nonoperative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.
V. Performance Data
The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic compression, static and dynamic torsion, static and dynamic compression shear per ASTM F2077-03; subsidence per ASTM F2267-04; and expulsion. The results of these studies were found to be substantially equivalent to legally marketed devices.
VI. Substantial Equivalence
Documentation was provided which demonstrated that the subject device is substantially equivalent to the following currently marketed devices: CORNERSTONE® PSR Cervical Interbody Fusion Device (K100214, SE 6/25/2010); VERTE-STACK® Spinal System (K041197, SE 8/9/2004); PLATEAU® (PLATEAU-C) Spacer System (K093093, Life Spine, SE 10/13/2010); and BENGAL® System (K081917, DePuy, SE 5/22/2009).
VII. Conclusion
It was determined that the subject device is substantially equivalent in design, materials, function, indications for use, and scientific technology to the predicate devices presented.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services of the USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 2 2011
Medtronic Sofamor Danek % Ms. Regina Holmes Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: KI11264
Trade/Device Name: CORNERSTONE® PSR Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 14, 2011 Received: September 15, 2011
Dear Ms. Holmes:
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
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Page 2 - Ms. Regina Holmes
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: CORNERSTONE® PSR Cervical Fusion System
Indications for Use:
The CORNERSTONE® PSR Cervical 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 autograft.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, And Restorative Devices | |
| 510(k) Number | K111264 |