SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

K002733 · Depuyacromed · KWP · Dec 15, 2000 · Orthopedic

Device Facts

• Record ID: K002733
• Device Name: SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
• Applicant: Depuyacromed
• Product Code: KWP · Orthopedic
• Decision Date: Dec 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for: ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) spondylolisthesis spinal stenosis fracture/dislocation atlantoaxial fracture with instability occipitocervical dislocation revision of previous cervical spine surgery tumors The occipital bone screws are limited to occipital fixation only. The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Device Story

Summit OCT Spinal System is a posterior spinal fixation construct for occipito-cervico-thoracic fusion. Components include rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable connectors, and Songer Cables. Surgeon attaches occipital plate to occiput via bone screws; transition rod connects to plate via locking mechanism (bolt/washer). Sub-axial stabilization achieved via cable connectors and sublaminar cabling; thoracic stabilization via polyaxial screws. Used in clinical/surgical settings by orthopedic or neurosurgeons. System provides rigid stabilization to promote spinal fusion, addressing instability from degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

Bench testing only. Biomechanical evaluation included static axial slippage, static torsion slippage, and static/dynamic construct axial compression bending and torsion testing.

Technological Characteristics

Manufactured from ASTM F-136 implant grade titanium alloy. System includes rods, plates, screws, and cable connectors. Fixation via occipital plates, sublaminar cabling, and polyaxial screws. Mechanical locking mechanisms for rod-to-plate and rod-to-screw interfaces.

Indications for Use

Indicated for patients requiring cervical spine and occipito-cervico-thoracic (occiput-T3) fusion due to discogenic neck pain, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial instability, occipitocervical dislocation, revision surgery, or tumors. Occipital screws restricted to occipital bone; minipolyaxial screws restricted to T1-T3 thoracic spine only.

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

• Ransford Cervical Fixation System (K965221)
• Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864)

Submission Summary (Full Text)

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| IX. 510(k) Summary | DEC 1 5 2000 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | DePuy AcroMed™, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 |
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | November 27, 2000 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | Summit Occipito-Cervico-Thoracic (OCT) Spinal System |
| PREDICATE DEVICES: | Ransford Cervical Fixation System (K965221)<br>Synthes CerviFix System (K982322, K984377, K990965,<br>K991089, K994187, K001864) |
| INTENDED USE: | When intended to promote fusion of the cervical spine and<br>occipito-cervico-thoracic junction (occiput-T3), the Summit<br>Occipito-Cervico-Thoracic (OCT) Spinal System is<br>indicated for:<br>ddd (neck pain of discogenic origin with<br>degeneration of the disc as confirmed by patient<br>history and radiographic studies) spondylolisthesis spinal stenosis fracture/dislocation atlantoaxial fracture with instability occipitocervical dislocation revision of previous cervical spine surgery tumors The occipital bone screws are limited to occipital fixation only.<br>The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. |

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The Songer Cable System to be used with the Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

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MATERIALS:

DEVICE DESCRIPTION:

Manufactured from ASTM F-136 implant grade titanium alloy.

The Summit OCT Spinal System consists of rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.

### PERFORMANCE DATA:

Biomechanical testing, including static axial slippage, static torsion slippage, static and dynamic construct axial compression bending and static and dynamic construct torsion, were conducted.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 5 2000

Mr. Frank Maas Regulatory Affairs Manager DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K002733

Trade Name: Summit Occipito-Cervico-Thoracic (OCT) Spinal System Regulatory Class: II Product Codes: KWP and MNI Dated: November 21, 2000 Received: November 22, 2000

### Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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### Page 2 - Mr. Frank Maas

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 A. Milkerner

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

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#### IV. Indications for Use

510(k) Number (if known): K002733

Summit Occipito-Cervical-Thoracic (OCT) Spinal System Device Name:

Indications For Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for:

- ddd (neck pain of discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies)
- spondylolisthesis t
- spinal stenosis .
- fracture/dislocation .
- atlanto/axial fracture with instability .
- occipitocervical dislocation .
- revision of previous cervical spine surgery
- tumors .

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Use: (Per 21 CFR 801.109)

DePuy AcroMed, Inc. K002733 - Indications for Use

_ OR Over-The-Counter

Mark N. Millikan

Division of General 510(k) Number