SYNTHES VECTRA-ONE SYSTEM

K071667 · Synthes Spine · KWQ · Nov 30, 2007 · Orthopedic

Device Facts

• Record ID: K071667
• Device Name: SYNTHES VECTRA-ONE SYSTEM
• Applicant: Synthes Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7) for the following indications: Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Spondylolisthesis Trauma (i.e., fractures or dislocations) Spinal stenosis Tumors (primary and metastatic) Failed previous fusions Pseudarthrosis Deformity (i.e., kyphosis, lordosis and/or scoliosis) Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

Synthes Vectra-One System is a spinal intervertebral body fixation orthosis consisting of titanium plates with an integrated one-step blocking mechanism. The mechanism uses a resilient clip pre-assembled in each bone-screw-receiving hole's radial groove to prevent screw back-out. The system accommodates both fixed-angle and variable-angle screws. It utilizes bone screws identical to those in the predicate Synthes Vectra System (K050451). The device is intended for use by surgeons in clinical settings for anterior cervical spine stabilization. By securing the construct to the vertebrae, the system provides stability to facilitate fusion and address spinal pathologies, potentially reducing pain and correcting deformity.

Clinical Evidence

No clinical data was required or provided for this device; substantial equivalence was demonstrated through non-clinical bench testing.

Technological Characteristics

Titanium spinal fixation plates featuring an integrated one-step blocking mechanism (resilient clip) to prevent screw back-out. Supports fixed-angle and variable-angle screw configurations. Compatible with existing Synthes Vectra System bone screws.

Indications for Use

Indicated for anterior cervical spine (C2-C7) fixation in patients with degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal stenosis, tumors, failed previous fusions, pseudarthrosis, or deformity (kyphosis, lordosis, scoliosis). Contraindicated for posterior element (pedicle) fixation.

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

• Synthes Anterior Cervical Vertebra Plates (K926453)
• Synthes Vectra System (K050451)
• Synthes Cervical Vertebrae Plates (K792352)
• DePuy Spine UniPlate Anterior Cervical Plate System (K042544)

Submission Summary (Full Text)

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

K071667

Page 1 of 2

## NOV 3 6 2007

### 510(k) Summary

| 510(k) Summary | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510(k) Contact: | Stacey Bonnell<br>Associate Regulatory Affairs Specialist<br>Telephone: [phone] Facsimile: 610-719-5102<br>Email: [e-mail] |
| Date Prepared: | November 26, 2007 |
| Trade Name: | Synthes Vectra-One System |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis<br>Class II<br>Orthopaedic and Rehabilitation Devices Panel<br>Product Code KWQ |
| Predicates: | Synthes Anterior Cervical Vertebra Plates (K926453)<br>Synthes Vectra System (K050451)<br>Synthes Cervical Vertebrae Plates (K792352)<br>DePuy Spine UniPlate Anterior Cervical Plate System (K042544) |
| Device Description: | The Synthes Vectra-One System consists of titanium plates with an integrated<br>one-step blocking mechanism. This blocking mechanism consists of a resilient<br>clip pre-assembled in each bone-screw-receiving hole's radial groove to block a<br>bone screw from backing out in the event of lost bone purchase. This construct<br>allows either a Fixed Angle Screw (a screw with fixed insertion angle) or<br>Variable Angle Screw (a screw with a range of insertion angle which permits the<br>screw-head to angulate inside the bone-screw-hole after being threaded into a<br>bone) to be used. The Vectra-One System uses the identical and compatible<br>bone-screws from the Synthes Vectra System (K050451). Furthermore, the<br>integrated one-step blocking mechanism is identical to the mechanism from the<br>Synthes Vectra System (K050451). |
| Intended Use/ Indications for Use: | The Vectra-One System is intended for anterior plate and screw fixation<br>of the cervical spine (C2-C7) for the following indications:<br>Degenerative disc disease (DDD) (defined as neck pain of<br>discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies) Spondylolisthesis Trauma (i.e., fractures or dislocations) Spinal stenosis Tumors (primary and metastatic) Failed previous fusions Pseudarthrosis Deformity (i.e., kyphosis, lordosis and/or scoliosis) |
| | <b>Warning:</b> This device is not intended for screw attachment or fixation to<br>the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. |
| 510(k) Summary | |
| Comparison of<br>the device to<br>predicate<br>device(s): | The Synthes Vectra-One System is a result of design modifications to the<br>predicate devices. It is substantially equivalent to the predicates in design,<br>function, material, and intended use. |
| Performance<br>Date<br>(Non-Clinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Bench testing results demonstrate that the Synthes Vectra-One System is<br>substantially equivalent to the predicate devices. |
| | Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for this device. |

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

Page 2 of 2

: 上一篇:

.

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

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of wavy lines, possibly representing human profiles.

Public Health Service

NOV 3 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synthes Spine % Ms. Stacey Bonnell 1302 Wrights Lane East West Chester, PA 19380

Re: K071667

> Trade/Device Name: Synthes Vectra-One System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 27, 2007 Received: November 28, 2007

Dear Ms. Bonnell:

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.

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

### Page 2 - Ms. Stacey Bonnell

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

Mark N Millman

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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

Page 1 of 1

# Spine

### Indications for Use Statement

510(k) Number: K071667 (if known)

Device Name: Synthes Vectra-One System

Indications for Use:

The Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7) for the following indications:

- Degenerative disc disease (DDD) {defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- " Spondylolisthesis
- · Trauma (i.e., fractures or dislocations)
- * Spinal stenosis
- · Tumors (primary and metastatic)
- " Failed previous fusions
- Pseudarthrosis
- · Deformity (i.e., kyphosis, lordosis and/or scoliosis)

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

| Prescription Use<br>(21 CFR 801 Subpart D) | AND / OR | Over-the-Counter Use<br>(21 CFR 801 Subpart C) |
|--------------------------------------------|----------|------------------------------------------------|
|--------------------------------------------|----------|------------------------------------------------|

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative, and Neurological Devices |
| 510(k) Number | L071667 |