ANTERIOR LUMBAR BUTTRESS SYSTEM

K040130 · Seaspine · KWQ · Mar 26, 2004 · Orthopedic

Device Facts

• Record ID: K040130
• Device Name: ANTERIOR LUMBAR BUTTRESS SYSTEM
• Applicant: Seaspine
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anterior Lumbar Buttress System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Device Story

Anterior Lumbar Buttress System; titanium alloy screws, buttress plates, and washer; used for anterior intravertebral body screw fixation/attachment to L1-S1 spine; provides stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease; intended for use caudal to bifurcation of great vessels; implanted by surgeons during spinal procedures; non-sterile, requires sterilization prior to use; includes manual instruments (plate inserter, hex driver, awl) for placement.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy components; buttress plate with screw and locking chamfer design; manual instrumentation (stainless steel, aluminum, Radel); non-sterile; requires sterilization prior to use.

Indications for Use

Indicated for patients with degenerative disc disease (DDD) requiring stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction at the L1-S1 spine.

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

• BowTi Anterior Buttress Staple System (K021039)
• Synthes Titanium Locking Plate System (K970048)

Submission Summary (Full Text)

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

K040130

Anterior Lumbar Buttress System

# 510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

| Submitter Information: | SeaSpine, Inc.<br>Contact: Kirt Stephenson<br>6276 River Crest Drive, Suite E<br>Riverside, CA 92507-0754<br>Phone: [phone] Fax: [phone] |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | The Regulatory Affairs Company<br>Contact: Diana Smith<br>727 Park Boulevard<br>San Diego, CA 92101<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | January 8, 2004 |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis<br>(Class II) - KWQ 888-3060 |
| Common/Usual Name: | Anterior Lumbar Buttress System |
| Device Trade Name: | Anterior Lumbar Buttress System |

The primary devices used for comparison in this summary are DePuy AcroMed™. Inc.'s BowTi Anterior Buttress Staple System (K021039) and Synthes' Synthes Titanium Locking Plate System (K970048).

- 1. Intended Use: (The statements of intended use are identical.)
The intended use of the Anterior Lumbar Buttress System and associated components is substantially equivalent to the intended use of the predicate devices. The Anterior Lumbar Buttress System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

$$
\xi \downarrow \quad \vert \quad \not\vdash \delta_{\sigma \circ \mathcal{J}}
$$

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

### Anterior Lumbar Buttress System

## 2. Description:

The Anterior Lumbar Buttress System includes titanium allov screws, buttress plates, and a washer. The screws will be offered in 5.5 and 6.5mm diameters and in six lengths, 18, 20, 22, 24, 25, and 26mm, for each diameter. The plates will be available in three sizes: 15 x 19, 15 x 20, and 15 x 21mm. The washer will be offered in a 15mm size to be compatible with the plates. The product is supplied "NON-STERILE" and must be sterilized prior to use

The Anterior Lumbar Buttress System also utilizes some instruments to assist in placement of the devices. These instruments include a plate inserter, hex driver, and an awl. The instruments will be fabricated from stainless steel, aluminum, and Radel. The product is supplied "NON-STERILE" and must be sterilized prior to use.

## 3. Technological Characteristics:

The Anterior Lumbar Buttress System has substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section. entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

### 4. Comparison Analysis:

The overall design of the Anterior Lumbar Buttress System is substantially equivalent to the predicate devices. See Table 1 below for a comparison of the Anterior Lumbar Buttress System and the predicate devices.

| Feature | Anterior Lumbar<br>Buttress System | Synthes Strimix<br>Locking Plate<br>System | BowTi Anterior<br>Buttress Staple<br>System | Substantially<br>Equivalent |
|------------------------|-----------------------------------------------------|--------------------------------------------|---------------------------------------------|-----------------------------|
| Intended Use | See Insert | Similar | Similar | Yes |
| Indications<br>for Use | See Insert | Same | Similar | Yes |
| Design | Buttress plate with<br>screw and locking<br>chamfer | Similar | Similar | Yes |
| Sizes | See prints | Similar | Similar | Yes |
| Material | Titanium | Same | Same | Yes |
| Sterile | Non-sterile | Same | Same | Yes |
| Mechanical<br>Strength | See test results | Similar | Similar | Yes |

Table 1: Summary of Design Comparison

$$\lnot \mathcal{Z} \text{ \lnot}$$

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

## Anterior Lumbar Buttress System

- A financial certification or disclosure statement or both, as required by part 54 (i) of this chapter:
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration.

- (i) For submission claiming substantial equivalence to a device which has been classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III Summary). The 510(K) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807,94.

A class III Certification and Summary is not needed for this submission as the products under consideration are class II.

- (k)_ A statement that the submitter believes, to the best of his or her knowledge. that all data and information submitted in the Premarket notification are truthful and accurate and that no material fact has been omitted.
A Premarket Notification Truthful and Accurate Statement is included on the following page.

Page 3 of 3

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

Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the border. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Ms. Diana Smith The Regulatory Affairs Company 727 Park Boulevard San Diego, California 92101

Re: K040130

Trade/Device Name: Anterior Lumbar Buttress System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 8, 2004 Received: January 21, 2004

Dear Ms. Smith:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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

#### Page 2 - Ms. Diana Smith

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark N Milliman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use Statement

510(k) Number (if known): _KO40130

Device Name: Anterior Lumbar Buttress System

The Anterior Lumbar Buttress System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Murle N. Milkerson

Division of Gener and Neurological Jevices

**510(K) Number** K040130

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

$$\begin{array}{rcl} \mathfrak{l} & \mathfrak{J}_{\circ} & \mathfrak{l} \\ \end{array} \quad \begin{array}{rcl} \mathfrak{J}_{\circ \circ} & \mathfrak{J}_{\circ \circ} \\ \end{array}$$

Prescription Use X
(Per 21 CFR § 801.109)

OR

Over-The-Counter-Use ---