(152 days)
The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 a laparoscopic or an open anterior approach.
The SOVEREIGN™ interbody device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation which has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.
The SOVEREIGN™ Spinal System 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 accompanying cover plate is designed to resist screw backout and must be used when screws are implanted. The implant is lens-shaped with three holes for placement of titanium screws. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The SOVEREIGNTM Spinal System interbody device is manufactured from PEEK Optima (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy:
This document is a 510(k) premarket notification for the SOVEREIGN™ Spinal System. It asserts substantial equivalence to a previously cleared device (INTREPID™ Spinal System) and does not contain detailed acceptance criteria and performance study results as would be found in a clinical trial report.
Therefore, the requested information cannot be fully extracted or inferred from the provided text. Specifically, clinical study data, acceptance criteria tables, sample sizes for test and training sets, details on expert panels, adjudication methods, or MRMC study results are not present in this document.
The document focuses on:
- Device Description: The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation, made from PEEK Optima with tantalum markers.
- Indications for Use: For degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, with autogenous bone graft, in skeletally mature patients who have had six months of non-operative treatment. Can be used stand-alone with three screws and a cover plate, or with supplemental fixation if fewer or no screws are used.
- Substantial Equivalence: The primary basis for clearance is substantial equivalence to the INTREPID™ Spinal System (K080083). Minor changes to labeling (indications, device description, contraindications).
- Regulatory Classification: Class II, regulated under 21 CFR 888.3080 (Intervertebral body fusion device).
No information regarding acceptance criteria or a specific study demonstrating performance against such criteria (as you would expect for a new, significant technological device) is provided in this 510(k) summary. This type of premarket notification for devices like the SOVEREIGN™ Spinal System often relies on demonstrating mechanical equivalence and biocompatibility, and substantial equivalence to a predicate device, rather than new clinical efficacy studies with predefined acceptance criteria.
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MEDTRONIC Sofamor Danek SOVEREIGN™ Spinal System November 2009
NOV 1 7 7009
l. Medtronic Sofamor Danek, Inc. Company: 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133
Contact:
Michael Scott Regulatory Affairs Specialist
U. Product Name: Common Name: Classification:
SOVEREIGN™ Spinal System Intervertebral Fusion Device 21 CFR 888.3080 -- Product Code: MAX
m. Description: The SOVEREIGN™ Spinal System 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 accompanying cover plate is designed to resist screw backout and must be used when screws are implanted. The implant is lens-shaped with three holes for placement of titanium screws. This device is intended to be radiolucent and the interior space of the product is to be used with bone graft.
The SOVEREIGNTM Spinal System interbody device is manufactured from PEEK Optima (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy:
Indications for Use: The SOVEREIGN™ Spinal System is indicated for use IV. with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels trom L2 to S1. 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 a laparoscopic or an open anterior approach.
The SOVEREIGN™ interbody device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation which has
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been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.
- V. Substantial Equivalence: Documentation including a risk analysis was provided which demonstrated the subject intervertebral devices to be substantially equivalent to INTREPID™ Spinal System components previously cleared in K080083 (SE 04/10/2008). Minor changes have been made to the Information for Use labeling. These changes consist of modified indications, a modified device description and additional contraindications and NOTA BENE.
© 2009 Medtronic Sofamor Danek
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Image /page/2/Picture/1 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 with three wing-like shapes. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 12 2011
Medtronic Sofamor Danek % Mr. Michael Scott Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K091813
Trade/Device Name: SOVEREIGN™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: November 5, 2009 Received: November 10, 2009
Dear Mr. Scott:
This letter corrects our substantially equivalent letter of November 17, 2009.
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 (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.
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
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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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milkersen
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): K091813
Device Name: SOVEREIGN™ Spinal System
Indications for Use:
The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc discase (DDD) at one or two contiguous kvels from L2 to S1. In pencills with the min degeneration of the disc confirmed by history and radiographic sudies. These patients should be skeleally mature and have had six months of non-operative trearment. These implants may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN™ interbody device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three thanium alloy screws and the accompanying cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation which has been clearly the FDA for use in the lumbar spine must be used to augment stability. The accompanying cover place MUST be used anytime the device is used with any number of screws.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use _ X Per 21 CFR 801.109
Over-The-Counter Use
Sonita for Mark. Mckesson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K091813
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§ 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.