MICOMED - HALM ZIELKE INSTRUMENTATION

K982006 · Micomed GmbH · KWQ · Jan 20, 1999 · Orthopedic

Device Facts

• Record ID: K982006
• Device Name: MICOMED - HALM ZIELKE INSTRUMENTATION
• Applicant: Micomed GmbH
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.

Device Story

Anterior spinal fixation system; components include Halm plates, screws, threaded rods, hex nuts, and fluted rods. Physician attaches plates to lateral aspect of vertebral body with screws; connects threaded rod to screws; secures with hex nuts. Performs partial correction of deformity; attaches pre-bent fluted rod; secures with lid and head screws. Rotates fluted rod to achieve derotation and relordosation; performs reverse rotation in thoracic spine to produce/enhance kyphosis. Segmental compression/distraction adjusts lordosis/kyphosis. Used in clinical/surgical settings by surgeons to stabilize spine and correct deformities.

Clinical Evidence

Bench testing only. Comparison of inherent stability (stiffness) against Zielke-VDS in calf and artificial spine models. Fatigue testing performed: one million cycles of axial compression at 1400 N and 2600 N with no device failure.

Technological Characteristics

Materials: Implant grade stainless steel (316LS) per ASTM F1314 or implant grade titanium per ASTM F136. Low profile spinal fixation system. Components: plates, screws, threaded/fluted rods, nuts, clamps. Manual surgical instrumentation. Non-powered.

Indications for Use

Indicated for patients with spinal deformities including scoliosis, kyphosis, and lordosis, and thoracolumbar spinal instability resulting from fracture.

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

• Zielke-Ventral Derotation Spondylodesis
• Kaneda SR Anterior Spinal System
• Anterior Isola Spinal System

Submission Summary (Full Text)

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K98 2006

## MICOMED - HALM ZIELKE INSTRUMENTATION; 510(k) Summary

Schafer MICOMED GmbH Company: Box 1664 73606 Schomdorf, Germany Phone: [phone] 49 71 61 94 96 46 Fax:

MICOMED - Halm Zielke Instrumentation Tradename:

Classification: Spinal Intervertebral Body Fixation Orthosis

- The principal components of the MICOMED Halm Zielke Description: Instrumentation, which is a low profile spinal fixation system, are as follows: Halm plates, screws, threaded rods, standard hex nut for threaded rods, fluted rods, vertebral clamps (double hole). Additional instrumentation includes: an awi, insertion instruments (Halm plates, threaded rod screws), screw wrench for hex nut, rod pusher for fluted rod, rod benders, in situ rod bender, grip tongs (threaded rod, fluted rod), and hook grasp tong.
The principal components of the MICOMED - Halm Zielke Instrumentation are utilized in the following manner. First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws, and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoligtic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve an appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis as desired.

- The components of the MICOMED Halm Zielke Instrumentation are Material: manufactured from implant grade stainless steel (316LS) conforming to ASTM F1314 specifications or implant grade titanium conforming to ASTM F136.
- The Halm Zielke Instrumentation System is an anterior spinal fixation Indications: system indicated for spinal deformities such as scollosis, kyphosis, and fordosis and thoracolumbar spinal instability caused by fracture.

Performance: The inherent stability (stiffness) of the MICOMED - Halm Zielke

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- Instrumentation has been compared to Zielke-VDS in two different Data: models. In addition, fatigue testing was performed. The results demonstrate that the calf and artificial spines were much more resistant to various deformational forces (axial compression, flexion, extension, lateral bending, torsion) after the MICOMED - Halm Zielke Instrumentation was applied as opposed to Zielke-VDS. Moreover, when the call spines were subjected to one million cycles of axial compression at loads of 1400 Newtons (N) and 2600 N, none exhibited any evidence of device failure.
The MICOMED - Halm Zielke Instrumentation is equivalent Substantial to the Zielke-Ventral Derotation Spondylodesis, Kaneda SR™ Anterior Equivalence: Spinal System, and Anterior Isola Spinal System.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

JAN 2 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micomed c/o Ms. Charmaine Henderson 511 Catalina Road 92835 Fullerton, California

K982006 Re: Halm Zielke Instrumentation Trade Name: Regulatory Class: II Product Code: KWQ October 23, 1998 Dated: Received: October 30, 1998

Dear Ms. Henderson:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸੇ 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.

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Page 2 - Ms. Charmaine Henderson

This letter will allow you to beqin 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.

If you desire specific advice for your device on our labeling requlation (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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K982006 510k:

Halm Zielke Instrumentation System Device:

Indications for Use:

The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.

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(Division Sign-Off) Division of General Restorative Devices 510(k) Number

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Prescription use

Over the Counter Use

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