DAYTONA ANTERIOR CERVICAL CAGE

K110733 · Spinenet, LLC · ODP · Aug 25, 2011 · Orthopedic

Device Facts

• Record ID: K110733
• Device Name: DAYTONA ANTERIOR CERVICAL CAGE
• Applicant: Spinenet, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Aug 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Daytona Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Daytona Anterior Cervical Cage System is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. The Daytona Anterior Cervical Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Daytona Anterior Cervical Cage is an intracorporeal implant for anterior cervical spondylodesis; wedge-shaped design with surface teeth to prevent migration. Implanted via anterior approach at C2-T1 levels to maintain disc space and facilitate fusion; requires autograft bone and supplemental fixation. Used by surgeons in clinical settings for patients with cervical DDD. Device provides structural support during fusion process.

Clinical Evidence

No clinical studies were performed. Bench testing conducted per ASTM F2077 and ASTM F2267, including static/dynamic compression, torsion, subsidence, and expulsion testing.

Technological Characteristics

Materials: PEEK (ASTM F2026) and Tantalum (ASTM F560). Wedge-shaped intervertebral body fusion device with surface teeth. Mechanical device; no energy source or software.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C2-T1). Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 weeks of prior non-operative treatment. Must be used with autograft and supplemental fixation.

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

• Spinal Elements Crystal Cervical Cage (K073351)
• Zimmer BAK/C Vista Interbody Fusion (P980048 S3)
• Integra Cervical Cage - Calvary Spine LLC (K082260)

Submission Summary (Full Text)

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## 510(k) Summary for the Daytona Anterior Cervical Cage

AUG 2 5 2011

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Daytona Anterior Cervical Cage.

Date Prepared: March 11, 2011

- 1. Submitter: Contact Person: J.D. Webb King Floyd The OrthoMedix Group, Inc. SpineNet, LLC 1001 Oakwood Blvd 1300 Minnesota Ave Round Rock, TX 78681 Winter Park, FL 32789 Telephone: [phone] Telephone: [phone]
- 2. Trade name: Common Name: Classification Name:

Daytona Anterior Cervical Cage intervertebral body fusion device intervertebral body fusion device - cervical 21 CFR section 888.3080 ODP Class II

- Predicate or legally marketed devices which are substantially equivalent: 3.
Spinal Elements Crystal Cervical Cage (K073351) Zimmer BAK/C Vista Interbody Fusion (P980048 S3) Integra Cervical Cage - Calvary Spine LLC (K082260)

#### 4. Description of the device:

The Daytona Anterior Cervical Cage system was developed as an intracorporeal implant for anterior cervical spondylodesis. The Daytona Anterior Cervical Cage is a system of wedge shaped implants and instruments designed for anterior cervical interbody fusion (ACIF). To prevent migration, the Daytona Anterior Cervical Cage has teeth on its superior and inferior surfaces.

### Materials:

PEEK conforming to ASTM F2026 Tantalum according to ASTM F560

### Function:

Maintain adequate disc space until fusion occurs.

### 5. Substantial equivalence claimed to predicate devices

Daytona Anterior Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, performance and function.

#### 6. Intended Use:

The Daytona Anterior Cervical Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Daytona Anterior Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Daytona Anterior Cervical Cage implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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### 7. Non-clinical Test Summary:

The following tests were conducted per ASTM F2077 and ASTM F2267: ·

- . Static and dynamic compression
- . Static and dynamic torsion
- ♪ Subsidence
- Expulsion .

### 8. Clinical Test Summary

No clinical studies were performed

#### മ് Conclusions Nonclinical and Clinical

The Daytona Anterior Cervical Cage is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

SpineNet, LLC % The OrthoMedix Group. Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

AUG 25 2011

Re: K110733

Trade/Device Name: Daytona Anterior Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 19, 2011 Received: July 22, 2011

Dear Mr. Webb:

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. J.D. Webb

or any Federal statutes and regulations administered by other Federal agencies. You must or any Federal Statures and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, morating, or device reporting (reporting of medical CFK Fall 807), labeling (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic a forth in the quality systems (QD) regalisms (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 If you desire specific advice for your device on our sales offices/ucm115809.htm for go to hills.inww.ida.gov/rtoour. Bru Collection is (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionaling by reference to premarket notification" (2) CFR Party note the regulation cintribut . Thisorananing 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 I ou may other only general miemational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address (600) 050 L614 00 (51 (5) MedicalDevices (Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Milleson

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

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Daytona Anterior Cervical Cage System

The Daytona Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Daytona Anterior Cervical Cage System is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. The Daytona Anterior Cervical Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KII0733 510(k) Number.