SCARLET® AC-T Secured Anterior Cervical Cage

K143214 · Spineart · OVE · Feb 23, 2015 · Orthopedic

Device Facts

• Record ID: K143214
• Device Name: SCARLET® AC-T Secured Anterior Cervical Cage
• Applicant: Spineart
• Product Code: OVE · Orthopedic
• Decision Date: Feb 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Device Story

SCARLET® AC-T is an intervertebral body fusion cage system; used for cervical fusion at levels C2-T1. Device consists of box-shaped spacer with central cavity for autograft bone and two integrated cancellous bone screws. System functions as standalone fixation; requires no supplementary hardware. Implanted by surgeons in clinical setting. Spacer available in multiple footprints/heights; screws available in multiple diameters/lengths to accommodate patient anatomy. Device facilitates spinal fusion; provides stability to disc space; intended to alleviate neck pain associated with degenerative disc disease.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static and dynamic axial compression, shear compression, and torsion (ASTM F2077), subsidence (ASTM F2267), and expulsion (ASTM Draft F04-25.02.02).

Technological Characteristics

Intervertebral body fusion cage and cancellous bone screws. Materials: Titanium alloy Ti6Al4V ELI (ISO 5832.3, ASTM F136). Spacer footprints: small/large; heights: 5-10 mm. Screws: 3-3.5 mm diameter, 12-18 mm length. Single-use, sterile, supplied with dedicated surgical instruments.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (neck pain of discogenic origin confirmed by history/radiography) at levels C2-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

• SCARLET® AC-T (K141314)
• STALIF® C Cervical Intervertebral Body Fusion Cage (K120819)
• Chesapeake® cervical-Ti Stabilization system (K111439)
• Zero-P anterior cervical interbody fusion device (K112459)
• AVS® Anchor-C Cervical Cage System (K102606)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2015

SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20 Route De Pre-bois-CP 1813 1215 Geneva Switzerland

Re: K143214

Trade/Device Name: SCARLET® AC-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: February 23, 2015 Received: February 23, 2015

Dear Mr. Pennesi:

This letter corrects our substantially equivalent letter of February 23, 2015.

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 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

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### Page 2 - Mr. Franck Pennesi

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); 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143214

Device Name SCARLET®AC-T

#### Indications for Use (Describe)

The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |

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## Traditional 510k SCARLET® AC-T Secured Anterior Cervical Cage

Image /page/3/Picture/1 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the word. The "ea" in "spineart" are purple, while the rest of the letters are black.

# 510(k) SUMMARY

| 510k | TRADITIONAL |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basis for submission | Extension of the range of SCARLET® AC-T devices cleared under K141314 |
| Submitted by | SPINEART |
| | International Center Cointrin |
| | 20 route de pré-bois |
| | CP1813 |
| | 1215 GENEVA 15 |
| | SWITZERLAND |
| | Franck PENNESI Director of Industry & Quality |
| Contacts | Phone : [phone] Fax : [phone] |
| | Mail : [e-mail] |
| | Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) [e-mail] |
| Date Prepared | February 23rd 2015 |
| Common Name | Intervertebral body fusion device |
| Trade Name | SCARLET® AC-T |
| Classification Name | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Class | II |
| Product Code | OVE |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed<br>predicate devices | Primary Predicate device: SCARLET® AC-T (K141314) manufactured by SPINEART<br>Additional predicates include: STALIF® C Cervical Intervertebral Body Fusion Cage<br>(K120819) manufactured by CENTINEL SPINE, INC; Chesapeake® cervical-Ti Stabilization<br>system (K111439) manufactured by K2M, INC; Zero-P anterior cervical interbody fusion<br>device (K112459) manufactured by SYNTHES SPINE; AVS® Anchor-C Cervical Cage<br>System (K102606) manufactured by STRYKER SPINE |
| Description of the device | Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the added<br>Scarlet® AC-T implant is a cervical Intervertebral Body Fusion device with integrated<br>Fixation. It consists of an interbody cage intended to be used with the two bone screws<br>provided as a stand-alone system and requires no additional supplementary fixation<br>system. Similar to the previously cleared Scarlet® AC-T Spinal System (K141314), the<br>added Scarlet® AC-T implant is a box-shaped spacer with a central cavity that can be<br>filled with bone graft (autograft) to facilitate fusion and with two cancellous bone<br>screws that pass through screw holes within its body. The added Scarlet® AC-T<br>intervertebral body fusion spacer comes in various sizes in order to accommodate<br>different patient anatomies. |
| Indications for use | The SCARLET® AC-T is intended to be used as an intervertebral body fusion cage as a<br>standalone system used with the two bone screws provided and requires no additional<br>supplementary fixation systems. It is inserted between the vertebral bodies into the<br>disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease<br>(defined as neck pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies). The device system is designed for use with autograft<br>bone to facilitate fusion. SCARLET® AC-T is intended to be used at one level. The cervical<br>cage is to be used in a skeletally mature patient who has had six weeks of non-<br>operative treatment prior to implantation of the cage. |
| Technological<br>Characteristics | The added SCARLET® AC-T cervical spacers are available in two footprints (small and<br>large) and six heights (from 5 to 10 mm). The added SCARLET® AC-T cervical spacers are<br>all made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. The<br>SCARLET® AC-T cancellous bone screws are available in two diameters (3 and 3.5 mm)<br>and four lengths (from 12 to 18 mm). The SCARLET® AC-T cancellous bone Screws are all<br>made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136.<br>SCARLET® AC-T (spacer and screw) is single-use device provided sterile and supplied<br>with dedicated surgical instruments. |
| Discussion of Testing | The following non-clinical tests were conducted: Static and dynamic axial compression,<br>Static and dynamic shear compression, Static and dynamic torsion testing according to<br>ASTM F2077, subsidence testing according to ASTM F2267, and expulsion testing<br>according to ASTM Draft F04-25.02.02. Results demonstrate comparable mechanical<br>properties to the predicate devices. |
| Conclusion | Non clinical performance testing demonstrate that the added SCARLET® AC-T spacer is<br>substantially equivalent to its predicate devices in terms of intended use, material,<br>design, mechanical properties and function. |

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