DYNESYS TOP-LOADING SPINAL SYSTEM

K073347 · Zimmer Spine, Inc. · NQP · Feb 8, 2008 · Orthopedic

Device Facts

• Record ID: K073347
• Device Name: DYNESYS TOP-LOADING SPINAL SYSTEM
• Applicant: Zimmer Spine, Inc.
• Product Code: NQP · Orthopedic
• Decision Date: Feb 8, 2008
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis), In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients: - · Who are receiving fusions with autogenous graft only: - · Who are having the device fixed or attached to the lumbar or sacral spine; - · Who are having the device removed after the development of a solid fusion mass. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

Device Story

Temporary spinal implant system; used to correct deformity and facilitate spinal fusion. Components: fixed pedicle screws (solid/cannulated, optional ceramic hydroxyapatite coating), set screws, polycarbonate urethane (PCU) spacers, polyethylene terephthalate (PET) cords. Used in lumbar/sacral spine; may connect to Optima ZS Spinal System via Zimmer DTO implant. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of spinal segments to support biological fusion process. Output is physical immobilization of vertebrae; aids clinical decision-making by providing structural support during healing. Benefits patient by stabilizing unstable segments and promoting fusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Posterior metal/polymer spinal system. Materials: pedicle screws, PCU spacers, PET cords. Features top-loading solid or cannulated shanks; optional ceramic hydroxyapatite (HA) coating. Designed for lumbar/sacral fixation. Class II device.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine instabilities or deformities, specifically degenerative spondylolisthesis with neurologic impairment and pseudoarthrosis. Contraindicated for spinal stabilization without fusion.

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

• Dynesys® Spinal System
• Medtronic Sofamor Danek CD HORIZON Spinal System

Reference Devices

• Optima ZS Spinal System

Submission Summary (Full Text)

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510(k) SUMMARY Zimmer® Dynesys® Top-Loading Spinal System

510(k) Number

| Date of Summary Preparation: | November 28, 2007 |
|------------------------------|-------------------------------------------------------------------------------|
| Submitter: | Zimmer Spine, Inc.<br>7375 Bush Lake Road<br>Minneapolis, MN 55439 |
| Company Contact: | Elsa A. Linke<br>Senior Regulatory Affairs Specialist |
| Manufacturer: | Zimmer GmbH<br>Sulzer Allee 8<br>CH-8404 Winterthur<br>Switzerland |
| Device Name: | Dynesys® Top-Loading Spinal System |
| Common Name: | Spinal Fixation System |
| Classification Name: | Posterior Metal/Polymer Spinal System, Fusion |
| Product Code: | NQP |
| Regulation Number: | 21 CFR 888.3070 |
| Device Classification: | Class II |
| Predicate Devices: | Dynesys® Spinal System<br>Medtronic Sofamor Danek CD HORIZON Spinal<br>System |

## Description of Device:

.

The Zimmer® Dynesys® Spinal System, including the Dynesys Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers, and polyethylene terephthalate (PET) cords.

The Dynesys pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with ceramic hydroxyapatite (HA). The Dynesys Spinal System is also cleared for connection with the Zimmer DTO implant. The Zimmer DTO implant allows the connection of the Dynesys Spinal System to the Optima ZS Spinal System when the two systems are used on contiguous levels.

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## Intended Use:

When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis),

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

- · Who are receiving fusions with autogenous graft only:
- · Who are having the device fixed or attached to the lumbar or sacral spine;
- · Who are having the device removed after the development of a solid fusion mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

### Comparison of Technological Characteristics:

The Dynesys Top-Loading Spinal System shares the same technological characteristics as the predicate devices. These characteristics include similar design, materials, range of sizes, technical requirements, and intended use.

#### Substantial Equivalence:

The Dynesys Top-Loading Spinal System is substantially equivalent to the predicate devices in design, materials, function and intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB

FEB - 8 2008

Re: K073347

Zimmer Spine, Inc.

% Ms. Elsa A. Linke 7375 Bush Lake Road

Minneapolis, Minnesota 55439

Trade/Device Name: Zimmer® Dynesys® Top-Loading Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NQP Dated: November 28, 2007 Received: November 29, 2007

Dear Ms. Linke:

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 In microco in microadic 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 and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's I'(<<)('1) v

The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as deecribed in your Section

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Page 2- Ms. Elsa A. Linke

510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,
Ashley B. Boam

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

### 510(k) Number (if known): K073347

# Device Name: Dynesys® Top-Loading Spinal System

#### Indications for Use:

When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

- · Who are receiving fusions with autogenous graft only;
- · Who are having the device fixed or attached to the lumbar or sacral spine;
- · Who are having the device removed after the development of a solid fusion mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

DRH, Office of Device Evaluation (ODE

Barbara Romelu da nam

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

**510(k) Number** K073342