ALTUM ANTERIOR CERVICAL PLATE

K103505 · Spinecraft, LLC · KWQ · Mar 15, 2011 · Orthopedic

Device Facts

• Record ID: K103505
• Device Name: ALTUM ANTERIOR CERVICAL PLATE
• Applicant: Spinecraft, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: - degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies), - spondylolisthesis, - trauma (i.e. fractures or dislocations), - tumors. . - deformity, . - pseudarthrosis. . - failed previous fusion, - spinal stenosis. .

Device Story

ALTUM Anterior Cervical Plate System provides anterior screw fixation for cervical spine stabilization. System comprises pre-lordosed titanium plates with vision ports for graft visualization and alignment notches for midline placement/temporary pin fixation. Self-tapping bone screws provide autogenic locking to plate upon insertion; no secondary locking mechanism required. Used by surgeons in clinical settings to stabilize spine during fusion development. Device facilitates precise placement and minimizes need for intraoperative plate contouring. Benefits include temporary stabilization to support bone fusion in patients with degenerative, traumatic, or neoplastic cervical conditions.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, specifically static compression bending, static torsion, and dynamic compression bending tests conducted per ASTM F1717-09.

Technological Characteristics

Material: Ti-6Al-4V (ASTM F136). Design: Pre-lordosed plate with vision ports and alignment notches. Fixation: Self-tapping bone screws with autogenic locking mechanism. Dimensions: Multiple lengths; screw diameters 4.0mm and 4.5mm. Sterilization: Non-sterile, intended for hospital sterilization.

Indications for Use

Indicated for skeletally mature patients requiring temporary stabilization of the anterior cervical spine (C2-C7) as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity, pseudarthrosis, failed previous fusion, and spinal stenosis.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Envision2 Anterior Cervical Plate System (K020649)
• Spider Cervical Plating System (K052292)

Submission Summary (Full Text)

{0}------------------------------------------------

K103505

SpineCraft, LLC

510(k) Premarket Notification ALTUM Anterior Cervical Plate

MAR 1 5 2011

# 510(k) Summarv for the ALTUM Anterior Cervical Plate

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

Date Prepared: 11/24/210

Submitter: SpineCraft. LLC 2215 Enterprise Drive Westchester, IL 60154 USA Tel: [phone]. Fax: [phone]

Establishment Registration No: Trade name: Common Name: Classification Name:

Product Code: Classification Panel: Contact Person: Ami Akallal-Asaad Director of Regulatory Affairs. SpineCraft, LLC [e-mail]

> 3004717358 ALTUM Anterior Cervical Plate System Anterior Cervical Plate Spinal intervertebral body fixation orthosis Per 21 CFR 88.3060 KWQ Class II 87

#### Predicate or legally marketed devices which are substantially equivalent:

Envision2 Anterior Cervical Plate System (K020649) / Ortho Development Spider Cervical Plating System (K052292) / X-Spine Systems

#### Description of the device:

The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The ALTUM anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The ALTUM plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the ALTUM Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.

#### Materials:

{1}------------------------------------------------

K103505

SpineCraft, LLC

## Ti-6Al-4V per ASTM F136

## Function:

The ALTUM Anterior Cervical Plate system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion.

# Substantial equivalence claimed to predicate devices

ALTUM Anterior Cervical Plate system is substantially equivalent to the Envision2 Anterior Cervical Plate System (K971730) and Spider Cervical Plating System (K052292) in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the ALTUM Anterior Cervical Plate system to these predicate devices.

| Device<br>Name<br>Items | ALTUM Anterior<br>Cervical Plate | Envision2 Anterior<br>Cervical Plate<br>System | Spider Cervical<br>Plating System |
|---------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Sponsor | SpineCraft | Ortho Development | X-Spine Systems |
| 510(k)<br>Number | Current submission | K020649 | K052292 |
| Device<br>Classification<br>Name/Product<br>Codes | Spinal intervertebral<br>body fixation orthosis<br>per 21 CFR 88.3060<br>KWQ | Spinal intervertebral<br>body fixation orthosis<br>per 21 CFR 88.3060<br>KWQ | Spinal intervertebral<br>body fixation orthosis<br>per 21 CFR 88.3060<br>KWQ |
| Classification | II | II | II |
| Material | Ti-6Al-4V per ASTM<br>F136 | Ti-6Al-4V per ASTM<br>F136 | Ti-6Al-4V per ASTM<br>F136 |
| # levels | multiple | multiple | multiple |
| Graft window | Yes | Yes | Yes |
| Variable angle<br>screw | Yes | Yes | Yes |
| Fixed screw | Yes | Yes | Yes |
| Screw size | Ø4.0, Ø4.5mm<br>variety of lengths | Ø4.0, Ø4.35mm<br>variety of lengths | Ø4.0, Ø4.25mm<br>variety of lengths |
| Pre-lordosed | Yes | Yes | Yes |
| Sterility | Non-sterile, sterilized<br>at hospital | Non-sterile, sterilized<br>at hospital | Non-sterile, sterilized<br>at hospital |

Figure (5)

{2}------------------------------------------------

K103505

510(k) Premarket Notification ALTUM Anterior Cervical Plate

## Intended Use:

The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, �
- trauma (i.e. fractures or dislocations), �
- tumors, .
- . deformity,
- pseudarthrosis, .
- . failed previous fusion,
- spinal stenosis. .

#### Non-clinical Test Summary:

The following tests were conducted:

ASTM F1717-09, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectorny Model. Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests. The results of this testing were compared to predicate systems, with the results being equal or higher than the predicate systems.

## Clinical Test Summary

No clinical studies were performed

#### Conclusions Nonclinical and Clinical

The ALTUM Anterior Cervical Plate System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

P.g 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right. The bird is drawn with simple, flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

SpineCraft, LLC % Ms. Ami Akallal-Asaad Director of Requlatory Affairs 2215 Enterprise Drive, Suite 1504 Westchester, Illinois 60154

MAR 1 5 2011

Re: K103505

Trade/Device Name: ALTUM Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: February 28, 2011 Received: March 01, 2011

Dear Ms. Akallal-Asaad:

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. Ilisting 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

{4}------------------------------------------------

Page 2 – Ms. Akallal-Asaad

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (8:00) 638-2041 or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aling B. n.t
for

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

Enclosure

{5}------------------------------------------------

# A. Indication for Use Statement

KIO3505 510(k) Number (if known): __ Device Name: ALTUM Anterior Cervical Plate System

# Indication for Use:

The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- spondvlolisthesis. .
- trauma (i.e. fractures or dislocations), .
- tumors. .
- deformity, .
- pseudarthrosis.
- failed previous fusion.
- spinal stenosis.

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 of Surgical, Orthopedic, and Restorative Devices

KID3505 510(k) Number_