Case 3:18-cv-00347-CAB-MDD Document 311-4 Filed 02/26/21 PageID.30229 Page 1 of 7
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`EXHIBIT 28
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`TO DECLARATION OF CHRISTIANA GARRETT
`IN SUPPORT OF NUVASIVE, INC.’S
`REPLY IN SUPPORT OF
`MOTION FOR PARTIAL SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE EXPERT OPINIONS
`(IMPLANT PATENTS)
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`Case 3:18-cv-00347-CAB-MDD Document 311-4 Filed 02/26/21 PageID.30230 Page 2 of 7
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`). FOOD & L
`kDIMINISTRATION
`
`November 27, 2018
`
`Alphatec Spine, Inc.
`Ms. Cynthia Adams
`Project Manager, Regulatory Affairs
`5818 El Camino Real
`Carlsbad, California 92008
`
`Re: K182746
`Trade/Device Name: ATEC ALIF and LLIF Spacer System
`Regulation Number: 21 CFR 888.3080
`Regulation Name; Intervertebral body fusion device
`Regulatory Class: Class II
`Product Code: MAX, PHM„.01/13
`Dated; September 27, 2018
`Received: September 28, 2018
`
`Dear Ms. Adams:
`
`We have reviewed your Section 510(k) premarket notification of intentto 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 May28, 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 .(PINTA), You may, therefore, market the device, subject to the general
`controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
`some cleared products may instead be combination products. The 510(k) Premarket Notification Database
`v./seri p ts/cdrhic fdocs/cfp mn/pm ri.c fin identifies combination
`located at https://www.accessdata.
`product submissions. 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
`
`U.S. Food & Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD. 20993
`www.ftia,g0V
`
`HIGHLY CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`ATEC_LLIF000966784
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`EXHIBIT 28
`Page 28
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`Case 3:18-cv-00347-CAB-MDD Document 311-4 Filed 02/26/21 PageID.30231 Page 3 of 7
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`K182746 — Ms. Cynthia Adams
`
`Page 2
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`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) for
`devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
`https:7www.fda._ov'CombinationProductsiGuidanceRegulatoryInformationiticm59'7488.htm); good
`manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)
`for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if
`applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
`1050.
`
`Also, please note the regulation entitled, "Ivlisbranding by reference to prernarket notification" (21 CFR Part
`807.97), For questions regarding the reporting of adverse events under the MDR regulation (21 CI-4 Part
`803), please go to http:/, www.fda.gol, /Medi c alDe vic es/Safety, RcportaPro b lem de fault.htm.
`
`For:comprehensive regulatory information.about medical devices and radiation-emitting products, including
`information about labeling regulations, please see Device Advice
`(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/)undCDRII Learn
`(http://www.fda.goviTraining/CDRFELeani). Additionally, youmay contact the .Division of Industry and
`Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
`(http : w w Ida.goviD10E) for more information or contact DICE by email (DICE4),Ida.nlis.gov) or phone
`(1-800-638-2041 or 301-796-7100).
`
`Sincerely,
`
`Katherine D.
`
`k -S
`
`for
`Mark N. Melkerson
`Director
`Division of Orthopedic Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`HIGHLY CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`ATEC_LLIF000966785
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`EXHIBIT 28
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`Case 3:18-cv-00347-CAB-MDD Document 311-4 Filed 02/26/21 PageID.30232 Page 4 of 7
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`Form Approved: OMB No. 0910-0120
`Food and Drug Administration
`Expiration Date: 06/30/2020
`Indications for Use
`See PRA Statement below.
`
`510(k) Number (if known)
`K182746
`
`Device Name
`ATEC ALIF and LLIF Spacer System
`
`Indications for Use (Describe)
`The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or
`two contiguous levels in the thoracolumbar spine.
`
`Thoracic: Tl-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a
`symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with
`or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
`
`Lumbar: L 1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or
`retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc
`confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients
`who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft
`comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA
`for use in the thoracic and lumbar spine.
`
`ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in
`addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate
`as the form of supplemental fixation.
`
`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."
`
`FORM FDA 3881 (7/17)
`
`Page 1 of 1
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`PSC Pubhshrng Services (301)
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`3-6740
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`EF
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`HIGHLY CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`Case 3:18-cv-00347-CAB-MDD Document 311-4 Filed 02/26/21 PageID.30233 Page 5 of 7
`510k Summary
`ATEC ALIF' and LLIF Spacer System
`K182747
`
`SUBMITTER:
`
`Contact Person:
`
`Alphatec Spine, Inc.
`5.818 El Camino Real
`Carlsbad, CA 92008
`Phone: (760) 431-9286
`Fax: (760) 431-0289
`
`Cynthia Adams
`Project Manager, Regulatory Affairs
`Contact Phone: (760) 494-6740
`
`Date Summary Prepared:
`
`September 27, 2018
`
`DEVICE
`
`Name of Device:
`Common or Usual Name:
`classification Name:
`
`Regulatory Class:
`Product Code:
`
`ATEC ALIT and LLIF Spacer System
`Intervertebral fusion device with bone graft, lumbar
`Intervertebral body fusion device
`(21 CFR 888.3080)
`Class II
`MAX, PHM, OVD
`
`LEGALLY MARKETED PREDICATE DEVICES
`
`ame
`
`Manufacturer
`
`ATEC Universal Spacer System
`
`Alphatec Spine
`
`duct Co
`510(0
`Primary Predicate 'Device
`PHM, MAX
`K180480
`Additional Predicate Devices
`Alphatec Spine:
`ATEC ALIF Spacer System
`K181453
`PHM, MAX
`Battalion Universal Spacer System Alphatee Spine
`K160958
`PHM, MAX
`Novel ALIF Spinal Spacer System Alphatee Spine
`K090782 MAX
`Battalion Universal Spacer System Alphatec Spine
`K143740 MAX
`Alphatee Spine
`AnteriorLumbar Plating System
`K101255 KWQ
`Zimmer Biomet Fusion System
`Zimmer Biomet
`K163543 MAX, OVD
`NuVasive Inc.
`K173892 MAX, PHM, OVD XLX Interbody System
`Zoe) Anterior Lumber Plate
`System
`Solus Anterior Lumbar Interbody
`Fusion System
`
`K121791 KWQ
`
`K102402 OVD
`
`CoreLink LLC
`
`Al hatee Spine
`
`K182746 Page 1 of 3
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`Case 3:18-cv-00347-CAB-MDD Document 311-4 Filed 02/26/21 PageID.30234 Page 6 of 7
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`IV. DEVICE DESCRIPTION
`
`The ATEC ALIF and LLIF Spacer System is an intervertebral body fusion system. The
`ATEC ALIF and LLIF Spacer System includes interbody implants marketed as Battalion
`Universal Spacer System and IdentiTi Porous Ti Spacer System, implanted from an
`anterior, anterolateral and lateral approach. The implants consist of various lengths, widths,
`heights and degrees of lordosis to accommodate individual patient anatomy. These
`implants are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM
`F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti-
`6A1-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM
`F67. The device includes rows of teeth on the surface of each end of the device which serve
`to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally,
`the commercially pure titanium implants are offered with a microstructure due to the
`layering of material that forms the porous geometry. This porous geometry extends to the
`superior and inferior surfaces of the device for implant fixation. All interbody implants
`feature an internal graft aperture for placement of graft material to promote fusion through
`the cage.
`
`The ATEC ALIF and LLIF Spacer System also includes LLB- AMP integrated fixation to
`be used with the LLIF interbody offerings. The LLIF AMP integrated fixation includes
`fixation plates, center locking screws and bone screws manufactured from titanium alloy
`per ASTM F136.
`
`V
`
`INDICATIONS FOR USE
`
`The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in
`skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
`
`Thoracic: Tl-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following
`discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including
`thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The
`lateral approach is limited to levels T5-6 to T11-T12.
`
`Lumbar: Ll-L2 to LS-S1, for the treatment of degenerative disc disease (DDD) with up to
`Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back
`pain of discogenic origin with degeneration of the disc confirmed by history and
`radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on
`patients who have had at least six months of non-operative treatment. It is intended for use
`with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft
`and supplemental fixation systems that are cleared by FDA for use in the thoracic and
`lumbar spine.
`
`ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF
`AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody
`implants with >20° lordosis must be used with an anterior plate as the folin of supplemental
`fixation.
`
`K182746 -Page 2 of 3
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`Case 3:18-cv-00347-CAB-MDD Document 311-4 Filed 02/26/21 PageID.30235 Page 7 of 7
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`VI.
`
`TECHNOLOGICAL COMPARISON TO P DICATES
`
`The technological design features of the subject implants were compared to the predicates
`in intended use, indications for use, design, function and technology and it was
`demonstrated that they are substantially equivalent.
`
`VII. PERFORMANCE DATA
`Nonclinical testing performed on the ATEC ALIF and LLIF Spacer System supports
`substantial equivalence to other predicate devices. The following testing was performed:
`
`• Dynamic axial compression testing per ASTM F2077
`Dynamic compression-shear testing per ASTM F2077
`Subsidence analysis
`* Push-out testing per ASTM F04-25-02-02 draft
`• Particulate and gravimetric analysis per ASTM F1877 and ASTM F1714
`Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
`
`The results demonstrate that the subject ATEC ALIF and LLIF Spacer System is
`substantially equivalent to other predicate devices for nonclinical testing.
`
`Clinical Information
`Not applicable; determination of substantial equivalence is not based on an assessment of
`clinical performance data.
`
`VIII. CONCLUSION
`
`Based upon the infoitnation provided in this 510(k) submission, it has been determined that
`the subject devices are substantially equivalent to legally marketed devices in regards to
`indications for use, intended use, design, technology, and performance.
`
`K182746 -Page 3 of 3
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