Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus

K192502 · Medtronic Sofamor Danek USA, Inc. · MAX · Jan 22, 2020 · Orthopedic

Device Facts

Record IDK192502
Device NameAnatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus
ApplicantMedtronic Sofamor Danek USA, Inc.
Product CodeMAX · Orthopedic
Decision DateJan 22, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3080
Device ClassClass 2
AttributesTherapeutic

Intended Use

The ANATOMIC PEEK Cervical Fusion System 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 ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK Cervical Fusion System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open anterior approach.

Device Story

The Anatomic PEEK Cervical Fusion System consists of cages of various widths and heights inserted between cervical vertebral bodies to provide support and correction during interbody fusion surgeries. The hollow geometry allows packing with autogenous bone, allograft bone, or demineralized allograft bone with bone marrow aspirate. The device is used in an open anterior approach by a surgeon; it requires supplemental fixation. The system provides structural support to the spinal column, facilitating fusion in patients with cervical disc disease. Benefits include stabilization of the vertebral segment and potential relief of nerve root or spinal cord compression.

Clinical Evidence

No new clinical trials were performed. The application relies on published clinical outcomes to support the use of demineralized allograft bone with bone marrow aspirate as a graft material.

Technological Characteristics

Implants are manufactured from medical grade PEEK (ASTM F2026) and titanium alloy (ASTM F136). Devices feature hollow geometry for bone graft packing and include tantalum radiopaque markers. Sterilization is provided for sterile devices. The system is designed for interbody fusion and requires supplemental fixation.

Indications for Use

Indicated for cervical interbody fusion in skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, osteophyte formation) at one level (C2-C3 to C7-T1) after 6 weeks of non-operative treatment. Requires supplemental fixation and bone graft (autogenous, allograft, or demineralized allograft with bone marrow aspirate). Implanted via open anterior approach.

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}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 23, 2021 Medtronic Sofamor Danek USA, Inc Emmarie Halteman Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132 Re: K192502 Trade/Device Name: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTCTM Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-LTM Anterior/Oblique Lumbar Fusion System, Elevate™ Spinal System, Perimeter™ Interbody Fusion Device, Pivox™ Oblique Lateral Spinal System, Sovereign™ Spinal System, T2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD, ODP, OVE, MOP, PLR Dear Ms. Halteman: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 22, 2020. Specifically, FDA is updating this SE Letter as an administrative correction, to update the Indications for Use and labeling. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840. Brent.Showalter@fda.hhs.gov. Sincerely, # Brent Showalter -S Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue. January 22, 2020 Medtronic Sofamor Danek USA, Inc Ms. Emmarie Halteman Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132 # Re: K192502 Trade/Device Name: Anatomic PEEK™ Cervical Fusion System. Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTCTM Spinal System, Capstone ControlTM Spinal System, Capstone Control PTCTM Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-LTM Anterior/Oblique Lumbar Fusion System, Elevate™ Spinal System, Perimeter™ Interbody Fusion Device, Pivox™ Oblique Lateral Spinal System, Sovereign™ Spinal System, T2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, ODP, OVE, MQP, PLR Dated: November 20, 2019 Received: November 22, 2019 Dear Ms. Halteman: 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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination 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. {2}------------------------------------------------ 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Brent Showalter -S Brent Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # 510(k) Summary Medtronic Sofamor Danek Medtronic Intervertebral Body Fusion Spinal Systems August 2021 | August 2021 | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Medtronic Sofamor Danek USA<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: (901) 396-3133<br>Fax: (901) 346-9738 | | | Contact(s) | Emmarie Halteman<br>Regulatory Affairs Specialist<br>Direct Telephone – 901-399-2216 | | | Date<br>Prepared | August 6, 2021 | | | Trade<br>Names | ANATOMIC PEEK™ Cervical Fusion System<br>ANATOMIC PEEK™ PTC Cervical Fusion Spinal System<br>Capstone™ Spinal System<br>Capstone Control™ Spinal System<br>Capstone Control PTC™ Spinal System<br>Capstone PTC™ Spinal System<br>Clydesdale™ Spinal System<br>Clydesdale PTC™ Spinal System<br>Cornerstone™ PSR Cervical Fusion System<br>Crescent™ Spinal System<br>Crescent™ Spinal System Titanium<br>Divergence-L™ Anterior/Oblique Lumbar Fusion System<br>Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only)<br>Elevate™ Spinal System<br>Perimeter Interbody Fusion Device<br>Pivox™ Oblique Lateral Spinal System<br>Sovereign™ Spinal System<br>T2 Stratosphere™ Expandable Corpectomy System (Cervical and Thoracolumbar) | | | Classification Names | Intervertebral Fusion Device with Bone Graft, Lumbar<br>Intervertebral Fusion Device with Integrated Fixation, Lumbar<br>Spinal Vertebral Body Replacement Device<br>Intervertebral Fusion Device with Bone Graft, Cervical<br>Intervertebral Fusion Device with Integrated Fixation, Cervical | | | Regulatory<br>Class | Class II | | | Regulation<br>Number | 888.3080; 888.3060 | | | Regulation<br>Name | Intervertebral Body Fusion Device; Spinal Intervertebral Body Fixation Orthosis | | | Device<br>Product<br>Classification Code | MAX; OVD; MQP; PLR; ODP; OVE | | | Predicate<br>Devices | Primary Predicate:<br>ARTIC-L™ 3D and ARTIC-XL™ 3D Ti Spinal System with<br>TiONIC™ Technology K190959 (S.E. 07/03/2019) | | | | | | | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | K192018 (S.E. 08/16/2019) | | | Additional Predicates: | | | | ANATOMIC PEEK™ Cervical Fusion System | K112444 (S.E. 11/15/2011);<br>K122037 (S.E. 03/22/2013);<br>K130177 (S.E. 09/23/2013) | | | ANATOMIC PEEK™ PTC Cervical Fusion Spinal System | K133653 (S.E. 04/28/2014);<br>K160528 (S.E. 03/28/2016) | | | Capstone™ Spinal System | K073291 (S.E. 04/24/2008);<br>K103731 (S.E. 07/18/2011);<br>K121760 (S.E. 08/29/2012);<br>K123978 (S.E. 04/09/2013);<br>K133650 (S.E. 12/20/2013);<br>K151128 (S.E. 08/06/2015) | | | Capstone Control™ Spinal System | K120368 (S.E. 04/09/2012);<br>K171107 (S.E. 09/26/2017);<br>K190165 (S.E. 05/06/2019) | | | Capstone Control PTC™ Spinal System | K171107 (S.E. 09/26/2017) | | | Capstone PTC™ Spinal System | K133205 (S.E. 03/12/2014);<br>K172199 (S.E. 09/19/2017) | | | Clydesdale™ Spinal System | K083026 (S.E. 12/29/2008);<br>K100175 (S.E. 06/02/2010);<br>K112405 (S.E. 11/21/2011);<br>K113528 (S.E. 12/20/2011);<br>K132897 (S.E. 12/11/2013);<br>K151128 (S.E. 08/06/2015) | | | Clydesdale PTC™ Spinal System | K133205 (S.E. 03/13/2014) | | | Cornerstone™ PSR Cervical Fusion System | K100214 (S.E. 06/25/2010);<br>K111264 (S.E. 10/12/2011);<br>K122037 (S.E. 03/22/2013);<br>K153373 (S.E. 01/19/2016) | | | Crescent™ Spinal System | K172199 (S.E. 09/19/2017);<br>K171031 (S.E. 07/06/2017);<br>K133216 (S.E. 11/22/2013);<br>K094025 (S.E. 04/26/2010) | | | Crescent™ Spinal System Titanium | K172199 (S.E. 09/19/2017);<br>K110543 (S.E. 08/09/2011)…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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