(26 days)
The CODMAN SLIM-LOC™ System is a permanent implant, generally indicated for short-term stabilization of the cervical spine from C2 to C7 employing screw fixation at the anterior face of the vertebral bodies. This product may be employed as an internal fixation device during the time interval required for arthrodesis.
Specific clinical indications for anterior plating include:
Instability caused by trauma;
Instability associated with correction of cervical lordosis and kyphosis deformity;
Instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery;
Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
Instability associated with single or multiple level corpectomy in advanced degenerative disk disease, spinal canal stenosis, and cervical myelopathy.
The CODMAN SLIM-LOC™ System consists of an assortment of implantable titanium alloy plates and screws. The plates have an integrated screw locking mechanism to prevent screw back out. A variety of cancellous screw types are provided for surgical convenience.
The provided text describes a 510(k) submission for the CODMAN® SLIM-LOC™ System, a spinal intervertebral body fixation orthosis. However, it does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria.
The document states: "This submission relied upon appropriate biomechanical testing necessary to support the device for its intended use." This indicates that biomechanical testing was performed, but it does not specify the acceptance criteria, the results, or details about the study design that would allow completion of the requested table and information.
Therefore, I cannot provide the detailed information requested in questions 1 through 9 based on the provided input. The document is primarily a 510(k) summary and the FDA's response letter indicating substantial equivalence, not a detailed report of the device's performance testing.
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Codman & Shurtleff, Inc.
Special 510(k): Device Modification
CODMAN® SLIM-LOCTM System
11/21/01
Page 1 of 1
| K013877 | ||
|---|---|---|
| 510(k) Summary | DEC 1 9 2001 | |
| Submitter: | Codman and Shurtleff, Inc.325 Paramount DriveRaynham, MA 02780 | |
| Contact Person: | Kathryn WunderPhone Number: (508) 880-8351Fax Number: (508) 828-3212 | |
| Date Prepared: | November 21, 2001 | |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body | |
| Proprietary Name: | CODMAN SLIM-LOC™ System | |
| Predicate Device: | CODMAN Anterior Cervical Plate (ACP) System(K953730) | |
| Intended Use: | The CODMAN SLIM-LOC™ System is a permanentimplant, generally indicated for short-term stabilization ofthe cervical spine from C2 to C7 employing screw fixationat the anterior face of the vertebral bodies. This productmay be employed as an internal fixation device during thetime interval required for arthrodesis. | |
| Materials: | Manufactured from ASTM F-136 implant grade titaniumalloy. | |
| Device Description: | The CODMAN SLIM-LOC™ System consists of anassortment of implantable titanium alloy plates and screws.The plates have an integrated screw locking mechanism toprevent screw back out. A variety of cancellous screwtypes are provided for surgical convenience. | |
| Performance Data: | This submission relied upon appropriate biomechanicaltesting necessary to support the device for its intended use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments and a flowing tail.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Ms. Kathryn Wunder Regulatory Affairs Specialist Codman & Shurtleff, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K013877
Trade Name: Codman SLIM-LOC™ Anterior Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: K WQ Dated: November 21, 2001 Received: November 23, 2001
Dear Ms. Wunder:
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 Eederal 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.
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Page 2 - Ms. Kathryn Wunder
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Salie McWitter, Ph.D., M.D.
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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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page 1 of 1
510(k) Number (if known): K013877
Device Name
CODMAN® SLIM-LOC™ System
Indications for Use
The CODMAN SLIM-LOC™ System's plates and screws are permanent implants, r no Obsidirated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. This product may be employed as an internal fixation device during the time interval required for arthrodesis.
Specific clinical indications for anterior plating include:
Instability caused by trauma;
Instability associated with correction of cervical lordosis and kyphosis deformity;
Instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery;
Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
Instability associated with single or multiple level corpectomy in advanced degenerative disk disease, spinal canal stenosis, and cervical myelopathy.
(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) | X |
|---|---|
| OR Over-The-Counter Use: |
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
5 Number
1 ( 01 2 2 4 1
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.