CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE

K100214 · Medtronic Sofamor Danek · ODP · Jun 25, 2010 · Orthopedic

Device Facts

Record IDK100214
Device NameCORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
ApplicantMedtronic Sofamor Danek
Product CodeODP · Orthopedic
Decision DateJun 25, 2010
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3080
Device ClassClass 2
AttributesTherapeutic

Intended 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 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 and is to be implanted via an open, anterior approach.

Device Story

The CORNERSTONE® PSR Spinal System is a PEEK cervical interbody fusion implant. It features four degrees of lordosis, lateral openings for bone incorporation, and superior/inferior teeth to engage vertebral endplates and resist backout. The device is implanted by a surgeon via an open, anterior approach. It must be used with autograft and supplemental fixation to facilitate spinal fusion. The implant provides structural support to the intervertebral space, aiming to alleviate symptoms of nerve root or spinal cord compression.

Clinical Evidence

No clinical data. Bench testing only: static and dynamic axial compression, compression shear, and torsion per ASTM F2077; subsidence testing per ASTM F2267.

Technological Characteristics

Material: medical grade polyetheretherketone (PEEK). Design: intervertebral body orthosis with four degrees of lordosis, lateral openings, and surface teeth. Mechanical testing standards: ASTM F2077 (axial compression, compression shear, torsion) and ASTM F2267 (subsidence).

Indications for Use

Indicated for cervical interbody fusion in skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, or osteophyte formation causing nerve root/spinal cord compression) at one level from C2-C3 to C7-T1, following six weeks of failed non-operative treatment.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ ## MEDTRONIC Sofamor Danek CORNERSTONE® PSR Spinal System Cervical Interbody Fusion Device June 2010 - K100214 - . I. Medtronic Sofamor Danek, Inc. Company: 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133 II. Product Name: CORNERSTONE® PSR Spinal System Spinal Intervertebral Body Orthosis Regulation Name: Cervical Interbody Fusion Device Classification: 21 CFR 888.3080 - Product Code: ODP - III. Description: The CORNERSTONE® PSR Spinal System is designed for use as a cervical intervertebral body fusion device. The device is manufactured from medical grade polyetheretherketone (PEEK) and is to be used with autograft. The device has four degrees of lordosis. The lateral walls of the device contain openings to allow for the incorporation of bone during the fusion process. The superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates and helps in resisting backout. - IV. 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 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 and is to be implanted via an open, anterior approach. - V. Performance Data: The following pre-clinical studies were conducted using worst case CORNERSTONE® PSR devices: static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077; as well Pay 1 £-2 {1}------------------------------------------------ ## K100214 as subsidence testing per ASTM F2267. The results of these studies were found to be substantially equivalent to legally marketed devices. - Substantial Equivalence: Documentation was provided which demonstrated that the VI. subject device is substantially equivalent to previously approved devices such as the PEEK PREVAIL™ Cervical Interbody Device (K073285, SE 05/15/08), the AFFINITY® Anterior Cervical Cage (P000028, Approved - 06/13/2002), the BAK/C® Cervical Interbody Fusion System (P980048, Approved – 04/20/2001); the LDR ROI-C Cervical Interbody Fusion Device (K091088, SE 07/14/09); Biomet Spine's C-Thru Cervical Interbody Fusion Device, (K092336, SE 10/15/09; and the VERTE-STACK® Spinal System (K041197, SE 08/09/04). Documentation included mechanical test results Page 2 of 2 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JYN 2 6 2010 Medtronic Sofamor Danek, Inc. % Mr. Lee Grant 1800 Pyramid Place Memphis. Tennessee 38132 Re: K100214 Trade/Device Name: CORNERSTONE® PSR Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 16, 2010 Received: June 18, 2010 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 mav 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 {3}------------------------------------------------ Page 2 - Mr. Lee Grant 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/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 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/Resourcesfor You/Industry/default.htm. Sincerely vours. Caibare buelus Mark N. Melkerso Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): KI CO214 Device Name: CORNERSTONE® PSR Spinal System 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 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 and is to be implanted via an open, anterior approach. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) 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) Arit (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 长108214 510(k) Number_
Innolitics
510(k) Summary
Decision Summary
Classification Order
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