K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM

K990959 · Spineology, Inc. · KWQ · Dec 27, 1999 · Orthopedic

Device Facts

• Record ID: K990959
• Device Name: K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
• Applicant: Spineology, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 27, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K-Centrum Anterior Spinal Fixation System is intended for alignment correction and stabilization of the thoracolumbar spine. The K-Centrum is also intended to provide stabilization to augment the development of a solid spinal fusion. The K-Centrum is intended for threaded anchor/ fixation attachment to the anterolateral intervertebral bodies from T10 to L2 only and not more than 2 motion segments. The K-Centrum is indicated for vertebral body fractures and tumors.

Device Story

K-Centrum Anterior Spinal Fixation System is a multi-component implantable construct for thoracolumbar spine stabilization and fusion augmentation. Components include two vertebral body anchors, one linkage rod, two set screws, and two locking caps. Surgeon uses unique instrumentation to place anchors parallel into anterolateral intervertebral bodies. Anchors are secured via threaded attachment; linkage rod connects anchors; set screws and locking caps secure the construct. Device is low-profile to minimize soft tissue/vascular impingement. Used by surgeons in clinical settings to correct alignment and stabilize the spine following fractures, tumors, or degenerative conditions. Provides mechanical support to resist tension, compression, bending, and torsion during bone healing.

Clinical Evidence

Bench testing only. Testing included static and fatigue testing per ASTM F 1717-96, interconnection testing (set screw to linkage rod), simulated use testing of the anchor guidance system, and comparative anchor pullout testing. Results demonstrated performance comparable to the predicate device and compliance with FDA guidance document 'Device Considerations for Spinal Fixation Device Systems' (1993).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V, ELI) per ASTM F 136-96. Design: Multi-component system with vertebral body anchors, linkage rod, set screws, and locking caps. Anchors secured via threaded attachment. Linkage element is a round-cornered rectangular rod. Low-profile design. Mechanical performance validated via static and fatigue testing.

Indications for Use

Indicated for patients requiring spinal stabilization for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, or corpectomy/vertebrectomy for tumor resection. Intended for use in the thoracolumbar spine (T10-L5) for less than 4 motion segments.

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

• Z-Plate Anterior Fixation System (K922543)

Submission Summary (Full Text)

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SPINEOLOGY, INC

11:25 DEC-22-1999 Spineology Group Premarket Notification K-Centrum Anterior Spinal Fixation System

DEC 27 1995

K990959

### 510(k) Summary [As required by 21 CFR 807.92(c)] 4

## 4.1 Submitter Information

Manufacturer's Name & Address Manufacturer's Contact Person Pamela Snyder Spineology Group, LLC Director of Clinical & Regulatory Affairs 1815 Northwestern Avenue Phone: [phone] Fax: [phone] Stillwater, MN 55082

#### 4.2 Device Names

| Proprietary Name: | K-Centrum Anterior Spinal Fixation System |
|--------------------------|---------------------------------------------------------------|
| Common/Usual Name: | anterior spinal fixation device |
| FDA Classification Name: | 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis |
| FDA Classification: | Class II, product code KWQ |

#### Predicate device 4.3

| Manufacturer | Device | 510(k) | Approved |
|---------------|----------------------------------|---------|----------|
| Sofamor Danek | Z-Plate Anterior Fixation System | K922543 | 5/19/93 |

#### Device Description ব

The K-Centrum Anterior Spinal Fixation System is a multi-component system. The construct utilizes all of the following implantable components: Vertebral Body Anchors (Two); Linkage rod (One); Set screws (Two); Locking caps (Two). The K-Centrum System includes unique instrumentation to assist the surgeon in placing the anchors parallel to each other.

## 4.5 Intended Use

The K-Centrum Anterior Spinal Fixation System is intended for alignment correction and stabilization of the thoracolumbar spine. The K-Centrum is also intended to provide stabilization to augment the development of a solid spinal fusion. The K-Centrum is intended for threaded anchor/ fixation attachment to the anterolateral intervertebral bodies from T10 to L2 only and not more than 2 motion segments. The K-Centrum is indicated for vertebral body fractures and tumors.

#### Technological Characteristic Comparisons 4.6

In addition to having comparable intended use and indications for use, the K-Centrum Anterior Spinal Fixation System and the Sofamor Danek Z-Plate ATL Anterior Fixation System are substantially similar in design features. Both devices are manufactured from the same titanium alloy (Ti-6A1-4V, ELI), in accordance with the same standard material specification (ASTM F 136 - 96). Both system configurations include anchors, longitudinal elements for linkage, and

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Spineology Group Premarket Notification K-Centrum Anterior Spinal Fixation System

locking mechanisms. For safety reasons, the K-Centrum has been designed to be a low-profile implant, to minimize the opportunity for device impingement on soft tissues and vascular structures. Anchors for both systems are secured to the vertebral body by threaded attachment. The details of anchor geometry differ, in part because the Z-Plate utilizes two small diameter anchors in each vertebral body, while the K-Centrum employs a single larger diameter anchor. Both anchor systems provide comparable surface area for direct bone contact. The longitudinal linkage elements are of different configurations. The K-Centrum utilizes a round-cornered rectangular rod, nearly symmetrical in the transverse plane, for linkage; the Z-Plate has a contoured, relatively wide plate, asymmetrical in the transverse plane. Both linkage elements are designed to resist tension, compression, bending, and torsion. In both the K-Centrum and Z-Plate systems, the linkage component is secured to the anchors via a threaded clamping locking component: a locking nut for the Z-Plate, a set screw and locking cap for the K-Centrum.

#### Summarv of Testing 4.7

Results from comparative mechanical testing results shows that the K-Centrum performs comparably to the Z-Plate, and both devices exceed the minimum performance requirements outlined in the FDA guidance document, "Device Considerations for Spinal Fixation Device Systems", FDA, 1993. The testing included: Static Testing per ASTM 1717-96; Fatigue Testing per ASTM F 1717-96; Interconnection Testing: Set screw to linkage rod; Simulated Use Testing of Anchor Guidance System; and Comparative Anchor Pullout Testing. No new types of safety or effectiveness questions were raised as a result of the testing or risk analysis performed for the K-Centrum Anterior Spinal Fixation System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 27 1999

Ms. Pamela Snyder Director of Clinical and Regulatory Affairs The Spineology Group, LLC 1815 Northwestern Avenue Stillwater, Minnesota 55082

Re: K990959

Trade Name: K-Centrum Anterior Spinal Fixation System Regulatory Class: II Product Code: KWQ Dated: September 28, 1999 Received: September 30, 1999

Dear Ms. Snyder:

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 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 requirement, 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 - Ms. Pamela Snyder

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" (21 CFR 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden
James E. Dillard III

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INTENDED USE STATEMENT

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510(k) Number (if known):

Device Name: K-Centrum Anterior Spinal Fixation System

Indications for Use:

DLU CLE LE - LE

The K-Centrum Anterior Fixator is intended for correction and stabilization of the spine. The K-Centrum is also intended to provide temporary stabilization and augment the development of a solid spinal fusion. The K-Centrum is intended for screw/bolt/fixation attachment to the anterolateral intervertebral bodies from T10 to L5 only and less than 4 motion segments.

The K-Centrum is indicated for degenerative disk disease, disk herniation, spondylosis, spondylolisthesis, burst fracture, failed surgery, corpectomy or vertebrectomy for tumor resection.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------|--------------------------------------------------------|--|
| | | |
| (Division Sign-Off) | ARE for JZD | |
| Division of General Restorative Devices | | |
| 510(k) Number | K990959 | |
| | | |

**Prescription Use** YES
(Per 21 CFR 801.109)

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