SYNTHES OC FUSION SYSTEM

K053418 · Synthes Spine Co.Lp · KWP · Sep 6, 2006 · Orthopedic

Device Facts

• Record ID: K053418
• Device Name: SYNTHES OC FUSION SYSTEM
• Applicant: Synthes Spine Co.Lp
• Product Code: KWP · Orthopedic
• Decision Date: Sep 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System. Synthes OC Fusion System is indicated for the following: DDD of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, atlanto/axial fracture with instability, occipital-cervical dislocation, revision of previous cervical spine surgery, and tumors (primary and metastatic) The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.

Device Story

Synthes OC Fusion System provides stabilization for occipital-cervical junction fusion. Components include occipital plates, screws, clamps, and rods. Surgeons create constructs using plates/rods or clamps/rods, with locking screws for connection. System integrates with previously cleared Synthes CerviFix and Axon hooks (C1-T3) for occipital-cervical-thoracic constructs. Occipital screws (4.5mm/5.0mm) allow variable angle insertion. Used by surgeons in clinical settings to stabilize the spine; output is a rigid mechanical construct promoting bone fusion. Benefits include structural support for patients with instability or degenerative conditions.

Clinical Evidence

Bench testing only; no clinical data required.

Technological Characteristics

Materials: Commercially pure Titanium (Grade 4) for plates; Titanium Aluminum Niobium (Ti-6Al-7Nb) for rod clamps, rods, and screws. Mechanical fixation system. Variable angle screw insertion. No software or energy source.

Indications for Use

Indicated for patients requiring stabilization for fusion of the occipital-cervical junction due to degenerative disc disease, spondylolisthesis, spinal stenosis, atlanto/axial fracture with instability, occipital-cervical dislocation, revision of previous cervical spine surgery, or tumors (primary/metastatic). Screws are contraindicated for placement in the cervical spine; limited to occiput.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Synthes Occipital-Cervical Plate/Rod and Hook System (K982322)

Reference Devices

• Synthes CerviFix System
• Synthes Axon System

Submission Summary (Full Text)

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K053418
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# 510(k) Summary

SEP -6 2006

| 510(k) Summary | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510(k) Contact: | Susan Lewandowski<br>Manager, Spine Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: 610-719-5102<br>Email: [e-mail] |
| Date Prepared: | August 28, 2006 |
| Trade Name: | Synthes OC Fusion System |
| Common Name: | Posterior, Cervical, Non-pedicle System |
| Classification: | 21 CFR 888.3050 Spinal Interlaminal Fixation Orthosis<br>Class II<br>Orthopaedic and Rehabilitation Devices Panel<br>Product Code KWP |
| Predicate Device(s): | K982322 - Synthes Occipital-Cervical Plate/Rod and Hook<br>System, cleared November 25, 1998 |

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| Device Description: | The Synthes OC Fusion System consists of occipital plates,<br>occipital screws, occipital clamps, and rods intended to provide<br>stabilization to promote fusion of the occipital-cervical junction.<br>This system allows an occipital-cervical construct of either the<br>occipital plate and rods or occipital clamps and rods. Rods are<br>connected to the occipital plate or occipital clamps using a<br>locking screw. A complete occipital-cervical-thoracic construct<br>can be created by using hooks (C1-T3) that have been previously<br>cleared within the Synthes CerviFix System and the Synthes Axon<br>System.<br>The occipital bone screws are available in 4.5mm and 5.0mm<br>diameters in lengths from 4mm to 18mm. Variable angle screw<br>insertion is possible.<br>The occipital clamps are available in either a one-hole or two-hole<br>configuration. The occipital plate is available in two sizes in<br>either a medial or lateral configuration for a total of four available<br>plates.<br>The plates are manufactured from commercially pure Titanium,<br>grade 4. The rod connection points (rod clamps) in the plate are<br>manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb)<br>as are the occipital clamps, rods, and occipital screws. |
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| Intended Use /<br>Indications for Use: | Synthes OC Fusion System is intended to provide stabilization to<br>promote fusion of the occipital-cervical junction. A complete<br>occipital-cervical-thoracic construct can be created by using<br>hooks (C1-T3) that have been previously cleared within the<br>Synthes CerviFix System and the Synthes Axon System.<br><br>Synthes OC Fusion System is indicated for the following: DDD of<br>the cervical vertebrae (neck pain of discogenic origin with<br>degeneration of the disc as confirmed by patient history and<br>radiographic studies), spondylolisthesis, spinal stenosis,<br>atlanto/axial fracture with instability, occipital-cervical<br>dislocation, revision of previous cervical spine surgery, and<br>tumors (primary and metastatic)<br><br>The use of screws is limited to placement in the occiput. Screws<br>are not intended to be placed in the cervical spine. |

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| Comparison of the<br>technological<br>characteristics of the<br>device to predicate<br>device(s): | The Synthes OC Fusion System is a result of design modifications<br>to the predicate devices. It is substantially equivalent to the<br>predicates in design, function, material and intended use. |
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| Performance Data<br>(Nonclinical and/or<br>Clinical): | Non-Clinical Performance and Conclusions:<br>Bench testing results demonstrate that the Synthes OC Fusion<br>System is substantially equivalent to the predicate devices.<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for this device. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP - 6 2006

Synthes Spine c/o Ms. Susan Lewandowski 1302 Wrights Lane East West Chester, PA 19380

Re: K053418

Trade Name: Synthes OC Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: August 28, 2006 Received: August 31, 2006

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 n your de rise 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.

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### Page 2 - Ms. Susan Lewandowski :

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be deviloed that I Dr o sation that your device complies with other requirements of the Act that I Dri has Intatutes 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 Of to rate 077) have 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. product racketing will allow you to begin marketing your device as described in your Section 510(k) rms leter watification. The FDA finding of substantial equivalence of your device to a legally promatics notifications on "cersults 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 other general managemal 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,

Barbara Inehm

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

Enclosure

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### Indications for Use Statement

510(k) Number K053418

Synthes OC Fusion System Device Name:

Synthes OC Fusion System is intended to provide stabilization to promote Indications for Use: fusion of the occipital-cervical junction. A complete occipital-cervicalthoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System and the Synthes Axon System.

Synthes OC Fusion System is indicated for the following:

- Degenerative disc disease of the cervical vertebrae (neck pain of . discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Spinal Stenosis .
- Fracture/Dislocation .
- . Atlanto/axial fracture with instability
- Occipital-cervical dislocation .
- Revision of previous cervical spine surgery .
- Tumors (primary and metastatic) .

The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical 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) :

510(k) Number Kos 3418

Concurrence of CDRH, Office of Device Evaluation (ODE)

| K053418 | Barbara Buehler |
|---------------------|-----------------|
| (Division Sign-Off) | for MKM |

Division of General, Restorative,
and Neurological DevicesENTIAL

CONFIDENTIAL Synthes OC Fusion System

Page 1 of 1 Traditional 510(k)