SYNTHES VECTRA SYSTEM

K050451 · Synthes Spine Co.Lp · KWQ · Mar 24, 2005 · Orthopedic

Device Facts

• Record ID: K050451
• Device Name: SYNTHES VECTRA SYSTEM
• Applicant: Synthes Spine Co.Lp
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Vectra System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). Synthes Vectra System is indicated for the following: 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, Pseudoarthrosis, Deformity (i.e., scoliosis, kyphosis, and/or lordosis)

Device Story

Synthes Vectra System is a cervical plating instrumentation set for anterior spinal fixation. System comprises one-to-four-level plates with cancellous and cortical fixed-angle and variable-angle screws. Plate features include 2.5 mm thickness, enlarged graft visibility windows, bend grooves, and fixed-angle screw DTS guide orientation holes. Device is used by surgeons in clinical settings to stabilize the cervical spine (C2-C7) following procedures or trauma. Plates and screws are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb); plate clip is manufactured from Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo). Device provides mechanical stabilization to facilitate fusion and address spinal pathologies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium Aluminum Niobium (Ti-6Al-7Nb) for plates/screws; Elgiloy (40Co-20Cr-16Fe-15Ni-7Mo) for plate clips. Form factor: 2.5 mm thick plates with graft visibility windows, bend grooves, and fixed-angle screw DTS guide orientation holes. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for anterior plate and screw fixation of cervical spine (C2-C7) in patients with degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal stenosis, tumors, failed fusions, pseudoarthrosis, or deformity (scoliosis, kyphosis, lordosis). Warning: Not for screw attachment/fixation to posterior elements (pedicles) of cervical, thoracic, or lumbar 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

• Synthes ACCS (K033844)

Submission Summary (Full Text)

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MAR 2 4 2005

## 3 510(k) Summary

| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Susan Lewandowski<br>Spine Regulatory Affairs Specialist<br>Telephone: [phone]<br>Facsimile: 610-719-5102 |
| Trade Name: | Synthes Vectra System |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code<br>and Classification: | KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis<br>Class II |
| Substantially<br>Equivalent Devices: | Synthes ACCS - K033844 |
| Device Description: | The Synthes Vectra System consists of one-level to four-level<br>plates with cancellous and cortical fixed-angle and variable-angle<br>screws. The plate attaches to the anterior portion of the vertebral<br>body of the cervical spine (C2-C7). The plate is 2.5 mm thick,<br>has bigger graft visibility windows (as compared to the predicate<br>device), bend grooves, and fixed-angle screw DTS Guide<br>orientation holes.<br>The plates and screws are manufactured from Titanium<br>Aluminum Niobium (Ti-6Al-7Nb), the same as the predicate<br>device. The plate clip is manufactured from Elgiloy (40Co-20Cr-<br>16Fe-15Ni-7Mo), the same as the predicate device. |
| Intended Use /<br>Indications for Use: | Synthes Vectra System is intended for anterior plate and screw<br>fixation of the cervical spine (C2-C7).<br>Synthes Vectra System is indicated for the following:<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.,<br>fractures or dislocations)<br>Spinal Stenosis, Tumors (primary and metastatic), Failed previous<br>fusions, Pseudoarthrosis, Deformity (i.e., scoliosis, kyphosis,<br>and/or lordosis) |

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Image /page/1/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 stripes forming its body and wing. The eagle faces left and is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

Ms. Susan Lewandowski Senior Regulatory Affairs Specialist Synthes Spine 1302 Wrights Lane East West Chester, PA 19380

Re: K050451

> Trade/Device Name: Synthes VECTRA System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 18, 2005 Received: February 22, 2005

Dear Ms. Lewandowski:

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

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Page 2 -- Ms. Susan Lewandowski

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
t (2005) (2006) (2006) (2006) (2006) (2005) (21 CFR 1000-1050, forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scetions 95 de scessi)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your artice of your device of your device to a legally
premarket notification. The FDA finding of substantial equiraced thus, p premarket notification. The FDA Innung of subsantial equive 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
rs in the many of the many of any of 6 0100 - Also - plasse note the regula If you desire specific advice for your uevice on our nooning nease note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the re contact the Office of Compliance at (240) 270 - FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obt Small "Misbranding by reference to premarkst nothlean (1)" on the Division of Small
other general information on your responsibilities under the Act from the 1800) 638-204 other general intornation on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its foll-free number (800) htm Manufacturers, International and Consumer Assistantes of the councilindustry/support/index.html.

Sincerely yours,

Stupk Rlurdu

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Special 510(k) Device Modification

## Indications for Use Statement

| 510(k) Number<br>(if known): | K050451 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes VECTRA System [modification to Synthes Anterior<br>Cervical Compression System (ACCS)] |
| Indications for Use: | Synthes VECTRA System is intended for anterior plate and screw<br>fixation of the cervical spine (C2-C7). |
| | Synthes VECTRA System is indicated for the following:<br>• Degenerative Disc Disease (DDD) (defined as neck pain of<br>discogenic origin with degeneration of the disc confirmed<br>by history and radiographic studies)<br>• Spondylolisthesis<br>• Trauma (i.e., fractures or dislocations)<br>• Spinal Stenosis<br>• Tumors (primary and metastatic)<br>• Failed previous fusions<br>• Pseudoarthrosis<br>• Deformity (i.e., scoliosis, kyphosis, and/or lordosis)<br>Warning: This device is not intended for screw attachment or<br>fixation to the posterior elements (pedicles) of the cervical,<br>thoracic, or lumbar spine. |

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

Styptik Alurku

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________