TELAMON® PEEK Spinal System
`Interbody Fusion Device
`510(k) Summary
`February 2011
`
`KilO0562
`Page 1 of 2
`
`NOV
`
`-9
`
`2011
`
`1. Company:
`
`Medtronic Sofamor Danek
`1800 Pyramid Place
`Memphis, TN 38132
`(901) 396-3133
`
`Contact:
`
`Regina Holmes
`Senior Regulatory Affairs Specialist
`
`HI. Proprietary Trade Name: TELAMON® Spinal System
`
`Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar
`
`Product Code: MAX (21 CFR 888.3080)
`
`Common Name: Interbody Fusion Device
`
`Ill. Product Description
`
`The subject TELAMONO PEEK Spinal System consists of vertebral body spacers which
`can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and
`correction during lumbar interbody fusion surgeries. The hollow geometry of the implant
`allows them to be packed with autogenous bone graft material. The TELAMONc' PEEK
`Spinal System also includes instrumentation that enables the surgeon to implant the devices
`via an open or a minimally invasive posterior approach.
`
`The device sizes are available in various height and lordotic angle options. The implant
`devices are manufactured from medical grade polyetheretherketone (PEEK - OPTIMA®
`LTI) per ASTM F2026 and also contain tantalum markers per ASTM F-560 so that the
`position of the implant can be determined on X-ray or other imaging.
`
`IV.
`
`Indications for Use
`
`The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous
`bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two
`contiguous levels from L2 to SI1. These DDD patients may also have up to Grade I
`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.
`
`1
`
`NUVASIVE 2015
`Medtronic v. NuVasive
`IPR2013-00506
`IPR2013-00507
`IPR2013-00508
`
`

`

`Kil10562
`Page 2 of 2
`
`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 are intended for
`bilateral placement in the lumbar spine. These devices are intended to be used with
`
`supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
`
`V. Performance Data
`
`The following pre-clinical studies were conducted using worst case TELAMON® devices:
`static and dynamic compression; and static and dynamic compression shear per ASTM
`F2077-03; and subsidence per ASTM F2267-04. 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: VERTE-STACK® Spinal System
`(K03 1780); CAPSTONE® Spinal System (K073291I); CRESCENTTM Spinal System
`
`(K094025); LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015); RAY®
`
`Threaded Fusion Cage (P950019); and Brantigan Lumbar 1/F CAGE® (P960025).
`
`VII. Conclusion
`
`When compared to the predicate devices, it was determined that the subject device is
`substantially equivalent based on the following factors:
`
`* The device designs are similar in shape, size, and footprint range.
`
`* The devices share the same intended use.
`
`* The devices are manufactured from the same material and under go the same
`
`sterilization methods.
`* The results of mechanical testing are comparable to the predicates and demonstrate
`that the subject device is as safe and effective as other legally marketed devices.
`
`2
`
`

`

`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`44g.
`
`public Health Ser vice
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Room -W066-G609
`Silver Spring, MD 20993-0002
`
`NOV
`
`9 92011
`
`Medtronic Sofamnor Danek
`%/ Ms. Regina Holmes
`Senior Regulatory Affairs Specialist
`1800 Pyramid Place
`Memphis, Tennessee 38 132
`
`Re: KlI10562
`Trade/Device Name: TELAMON® PEEK Spinal System
`Regulation Number: 21 CJR 888.3080
`Regulation Name: Intervertebral body fusion device
`Regulatory Class: Class 11
`Produlct Code: MAX
`Dated: October 13, 2011
`Received: October 14, 2011
`
`Dear Ms. Holmes:
`
`We have reviewed your Section 5 10(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 lrior 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 mhay, 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 11 (Special Controls) or class Ill (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
`
`3
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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 CER Part 801); medical device reporting (reporting of medical
`device-related adverse events) (2 1 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 53 1-542 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://vwvw.fda.gov/AboutFDA/CenitersOffices/CDR-H/CDRHOffices/ucml 15809.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
`CER Part 803), please go to
`http://www.fda.,gov/MedicalDevices/Safety/ReportaProblem/default.htm
`of Surveillance and Biometrics/Division of Postmarket Surveillance.
`
`for the CDRH's Office
`
`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) 63 8-2041 or (301) 796-7100 or at its Internet address
`littp://www.fda.gov/MedicalDcvices/ResourcesforYou/Industrv/defaulthtm.
`
`Sincerely yours,
`
`& J rQ
`
`JYMark N. Melkerson
`Director
`Division of Surgical, Orthopedic
`and Restorative Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`4
`
`

`

`5 10(k) Number (if known): K1 10 5 62
`
`Device Name: TELAMON® PEEK Spinal System
`
`Indications for Use:
`
`The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous
`bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two
`contiguous levels from L2 to SI1. These DDD patients may also have up to Grade I
`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 are intended for bilateral
`placement in the lumbar spine. These devices are intended to be used with supplemental
`fixation instrumentation, which has been cleared for use in the lumbar spine.
`
`Prescription Use _X_
`(Part 21 CFR 801 Subpart D)
`
`AND/OR
`
`Over-The-Counter Use
`(21 CER 807 Subpart C)
`
`___
`
`(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
`
`Concurrence of CDRH, Office of Device Evaluation (ODE)
`
`(Divj1ion Sign-Off)
`
`Od Restorative Devices
`
`5 10OMNumiber Ki!4
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`5
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