MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

K022190 · Depuyacromed · MNI · Jul 24, 2002 · Orthopedic

Device Facts

• Record ID: K022190
• Device Name: MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
• Applicant: Depuyacromed
• Product Code: MNI · Orthopedic
• Decision Date: Jul 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• 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. The Songer Cable System to be used with the Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine. The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Device Story

Summit OCT Spinal System is a posterior spinal fixation construct; used for occipito-cervico-thoracic fusion. Components include plates, bone screws, rods, transverse rod connectors, cable connectors, dual wedding band/axial connectors, set screws, and minipolyaxial screws. System utilizes Songer Cables for posterior cervical attachment. Occipital plate fixed to occiput via bone screws; transition rod attached to plate via bolt/washer locking mechanism. Sub-axial stabilization achieved via cable connectors and sublaminar cabling; construct ends stabilized with polyaxial screws in upper thoracic spine (T1-T3). System compatible with ISOLA, TiMX, Monarch, and MOSS Miami systems via specific connectors and dual diameter rods. Operated by surgeons in clinical/OR settings to stabilize spine, promote fusion, and address instability or deformity. Benefits include structural support for spinal segments during healing.

Clinical Evidence

Bench testing only. Biomechanical testing performed, including static and dynamic cantilever beam testing and axial slip testing.

Technological Characteristics

Construct components: plates, screws, rods, connectors, cables. Material: ASTM F-136 implant grade titanium alloy. Mechanical fixation via locking mechanisms (bolts, washers, nuts, set screws). Connectivity: compatible with ISOLA, TiMX, Monarch, and MOSS Miami systems via dual wedding band/axial connectors and dual diameter rods. No software or electronic components.

Indications for Use

Indicated for patients requiring fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) due to DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, or tumors.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Summit OCT Spinal System (K002733, K010681, K013222)

Reference Devices

• ISOLA System
• TiMX System
• Monarch System
• MOSS Miami System
• Songer Cable System

Submission Summary (Full Text)

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,

| SUBMITTER: | DePuy AcroMed™, Inc. 325 Paramount Drive Raynham, MA 02780 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | July 03, 2002 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | Summit OCT Spinal System |
| PREDICATE DEVICES: | Summit OCT Spinal System (K002733, K010681, K013222) |
| 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: <ul><li>ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)</li><li>spondylolisthesis</li><li>spinal stenosis</li><li>fracture/dislocation</li><li>atlantoaxial fracture with instability</li><li>occipitocervical dislocation</li><li>revision of previous cervical spine surgery</li><li>tumors</li></ul> 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.

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The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.

KU22190

Manufactured from ASTM F-136 implant grade titanium MATERIALS: alloy.

The Summit OCT Spinal System consists of plates, nuts, DEVICE DESCRIPTION: bone screws, rods, transverse rod connectors, cable connectors, dual wedding band and axial 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.

The Summit OCT System can also be linked to the ISOLA, TiMX. Monarch and MOSS Miami Systems using the dual wedding bands and axial connectors, and via dual diameter rods.

PERFORMANCE DATA:

Biomechanical testing, including static and dynamic cantilever beam testing and axial slip testing, were conducted.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". The caduceus is represented by a series of three overlapping profiles.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 4 2002

Ms. Karen Jurczak Regulatory Affairs Associate DePuy AcroMed. Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K022190

Trade/Device Name: Summit Occipito-Cervico-Thoracic (OCT) Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, KWP Dated: July 3, 2002 Received: July 5, 2002

Dear Ms. Jurczak:

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.

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Page 2 - Ms. Karen Jurczak

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

Mark M Melkerson

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

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## Summit OCT Spinal System

| III. | Indications for Use |
|---------------------------|--------------------------|
| 510(k) Number (if known): | K022190 |
| Device Name: | Summit OCT Spinal System |

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 .
- spinal stenosis .
- fracture/dislocation .
- atlanto/axial fracture with instability .
- occipitocervical dislocation t
- revision of previous cervical spine surgery .
- . tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolvaxial screws are 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.

The Summit OCT System can also be linked to the ISOLA. TiMX. Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: (Per 21 CFR 801.109) | OR Over-The-Counter Use: |
|----------------------------------------|--------------------------|
|----------------------------------------|--------------------------|

*for*

(Division Sign-Off)
Division of Ca. end. Restorative
and Neurological Devices

| DePuy AcroMed, Inc. Special 510(k) | Page 4 |
|------------------------------------|---------|
| 510(k) Number: | K022190 |