ArcadiusXP C Spinal System

K153629 · Aesculap Implant Systems, Inc. · OVE · May 25, 2016 · Orthopedic

Device Facts

• Record ID: K153629
• Device Name: ArcadiusXP C Spinal System
• Applicant: Aesculap Implant Systems, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: May 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies) using autograft bone. Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.

Device Story

Standalone cervical interbody fusion system; provides structural stability post-discectomy. Consists of PEEK cage with titanium plasma spray coating and two titanium alloy bone screws. Used in spinal fusion procedures; implanted by surgeons in clinical settings. Device acts as mechanical support for fusion; requires no supplementary fixation. Benefits patient by stabilizing disc space and promoting fusion using autograft bone.

Clinical Evidence

Bench testing only. No clinical data provided. Performance demonstrated via mechanical testing per ASTM F2077, F2267, F1877, and F-04.25.02.02, plus coating characterization per ASTM F1854, F1147, F1044, F1160, and F1978.

Technological Characteristics

Intervertebral body fusion device. Materials: Medical grade LT1 PEEK (ASTM F2026) with PlasmaporeXP vacuum titanium plasma spray coating; Ti6Al4V titanium alloy (ISO 5832/3) for screws and markers. Standalone system; no software or electronics.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (discogenic pain with confirmed degeneration) requiring one-level spinal fusion from C2/C3 to C7/T1. Requires autograft bone and at least 6 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

• Biolign Stand Alone Cervical Cage (STACC) ACIF System (K130274)

Reference Devices

• Stalif C (K150053 / K142079)
• SIBD XP Spinal System (K111122)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.

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

May 25, 2016

Aesculap Implant Systems, Incorporated Ms. Lisa Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K153629

Trade/Device Name: Arcadius C Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: April 25, 2016 Received: April 26, 2016

Dear Ms. Boyle:

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 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K153629

Page 1 of 1

510(k) Number (if known) K153629

Device Name ArcadiusXP C Spinal System

#### Indications for Use (Describe)

The ArcadiusXP C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space for the treatment of cervical degenerative disc discogenic pain with degeneration ofthe disc confirmed by history and radiographic studies) using autograft bone.

Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the ArcadiusXP C Spinal System.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap® Implant Systems (AIS) – Arcadius*P C Spinal System May 18, 2016

| COMPANY: | Aesculap®Implant Systems, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 3005673311 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle<br>610-984-9274 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | ArcadiusXP C Spinal System |
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Intervertebral Fusion Device with Integrated Fixation<br>Cervical |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | OVE |

### PURPOSE FOR PREMARKET NOTIFICATION

The purpose for this submission is to gain marketing clearance for the Arcadius C Spinal System.

### DEVICE DESCRIPTION

The Arcadius X C spinal system is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy procedures. The system consists of a PEEK cage and two bone screws. The PEEK cages are manufactured from a radiolucent material medical grade LT1 polyetheretherketone (PEEK) per ASTM F2026, with a titanium layer and a vacuum titanium plasma spray coating (PlasmaporeXP). The Arcadius N C implants are offered in various heights and geometrical options to fit the anatomical needs of a wide variety of patients. The Arcadius C implant is available in two footprints. The wide central opening holds optimal graft material. The screws are 4mm in diameter and offered in three lengths. The fixation screws and radiographic markers are manufactured of titanium alloy, (Ti6Al4V) according to ISO 5832/3.

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## INDICATIONS FOR USE

The Arcadius C Spinal System is intended to be used as an intervertebral body fusion device as a standalone system used with the supplied bone screws and requires no additional supplementary fixation system. It is intended for spinal fusion procedures at one level in the cervical spine from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies) using autograft bone.

Patients should be skeletally mature and must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Arcadius C Spinal System.

# SUBSTANTIAL EQUIVALENCE

The Arcadius XX C Spinal System is substantially equivalent to the predicates in design, material, function and performance. Based on test results and additional supporting documentation provided. Aesculap believes that the subject device demonstrates substantial equivalence.

## PERFORMANCE DATA

As recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device non-clinical testing was performed to demonstrate that the AIS Arcadius C Spinal System is substantially equivalent to other predicate devices. The following testing was performed:

- · Static and dynamic torsion per ASTM F2077
- · Static and dynamic axial compression per ASTM F2077
- Static and dynamic shear compression testing per ASTM F2077
- · Subsidence per ASTM F2267
- · Wear Debris per ASTM F1877
- · Expulsion per ASTM Draft Standard F-04.25.02.02

In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing recommended in the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post-market Surveillance Requirements." The following tests were performed:

- · Microstructure of the coating per ASTM F1854
- · Static Tensile Strength per ASTM F1147
- · Static Shear Strength per ASTM F1044
- · Shear Fatigue Test per ASTM F1160
- Abrasion Resistance per ASTM F1978

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The results of these tests showed that the Arcadius X C Spinal System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.

#### PRIMARY PREDICATE

Elite Surgical Supplies: Biolign Stand Alone Cervical Cage (STACC) ACIF System – K130274

## REFERENCE DEVICES

Centinel Spine: Stalif C® – K150053 / K142079 Aesculap Implant Systems: SIBD XP Spinal System – K111122