BONE GRAFT WASHER, MODEL 9090114 - 9090118

K994122 · Danek Medical, Inc. · KWQ · Feb 18, 2000 · Orthopedic

Device Facts

• Record ID: K994122
• Device Name: BONE GRAFT WASHER, MODEL 9090114 - 9090118
• Applicant: Danek Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

Device Story

Bone Graft Washer II is a spinal implant component used to stabilize bone grafts during spinal fusion procedures. The device is designed for use with 6.5mm low-profile screws. It functions as a mechanical stabilizer to maintain graft position at a single spinal level (T1-S1). The device is intended for use by surgeons in clinical settings, either as a standalone component or in conjunction with other anterior, anterolateral, or posterior spinal fixation systems. By securing the bone graft, the washer facilitates the development of a solid spinal fusion, potentially improving patient outcomes in spinal stabilization surgeries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fabricated from medical grade titanium alloy (ASTM F136 or ISO 5832-3) or commercially pure titanium (ASTM F67 or ISO 5832-2). Mechanical implant component designed for use with 6.5mm low-profile screws. Sold sterile or non-sterile.

Indications for Use

Indicated for patients requiring bone graft stabilization at one spinal level (T1-S1) to aid in spinal fusion.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

# FEB 1 8 2000

### BONE GRAFT WASHER 510(k) Summary

### February 14, 2000

Medtronic Sofamor Danek USA I, Company: 1800 Pyramid Place Memphis, TN 38132 [phone]

#### Proposed Proprietary Trade Name: BONE GRAFT WASHER II.

#### III. Description

The BONE GRAFT WASHER is used with a 6.5mm low profile screw to provide bone graft stabilization during the development of a solid spinal fusion. Instrumentation is also available to facilitate implantation of the device components.

BONE GRAFT WASHER components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The BONE GRAFT WASHER may also be fabricated from commercially pure titanium described by such standards as ASTM F67 or ISO 5832-2. The implant components may be sold either sterile or non-sterile.

#### IV. Indications for Use

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

#### V. Substantial Equivalence

The BONE GRAFT WASHER is substantially equivalent to other commercially accepted devices. C2000 Medtronic Sofamor Danek

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 8 2000

Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K994122

Trade Name: Bone Graft Washer Regulatory Class: II Product Code: KWQ Dated: December 3, 1999 Received: December 7, 1999

Dear Dr. Treharne:

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 control provisions of the Act. The general control 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 OS 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.

{2}------------------------------------------------

Page 2 - Richard W. Treharne, Ph.D.

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.

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.

Nef R.P. Ogden

James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): \(99-4122

BONE GRAFT WASHER Device Name: __________

Indications for Use:

.

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (TI-SI) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Concurrence of CDRH, Office of Evaluation (ODE) | |
|-------------------------------------------------|----------------------|
| NRO for JTO | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K994122 |
| Prescription Use | X |
| (Per 21 CFR 801.109) | OR |
| (Optional 1-2-96) | Over-the-counter Use |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------