(21 days)
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for deqenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 -- S1 vertebral joint, having fusions with autogenous bone graft. with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.
The Moss Miami Spinal System Polyaxial Screws and Polyaxial Reduction Screws are designed to accept a 5.5mm rod and are available in various sizes.
The Moss Miami Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.
The provided text describes a 510(k) premarket notification for the Moss Miami Spinal System Polyaxial Screws, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data.
Therefore, the document does not contain the requested information regarding acceptance criteria, device performance tables, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment.
Instead, the submission relies on the established safety and effectiveness of predicate devices. The FDA determines "substantial equivalence" based on factors like:
- Intended Use: The Moss Miami Spinal System Polyaxial Screws share similar intended uses with the predicate devices.
- Technological Characteristics: The device is described as Polyaxial Screws designed to accept a 5.5mm rod, which is compared to existing Moss Miami Spinal System components.
- Performance Data: While not explicitly detailed, 510(k) submissions typically include non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate that the new device performs as safely and effectively as the predicate device and meets established engineering standards. However, these specific test results are not part of this summary document.
In summary, this document is a regulatory approval notice based on substantial equivalence, not a study report demonstrating acceptance criteria and device performance as would be found in a clinical trial.
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KOSO382
FEB 2 6 2003
page of
510(k) Summarv IX.
SUBMITTER:
DePuy AcroMed, Inc. 325 Paramount Drive Raynham, MA 02780
CONTACT PERSON: Lisa A. Gilman
DATE PREPARED: January 30, 2003
CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation
PROPRIETARY NAME: Moss Miami Spinal System Polyaxial Screws
PREDICATE DEVICES: Moss Miami Spinal System (K953915, K982320, K982511, K982011, K983583, K992168, K011182)
DEVICE DESCRIPTION: The Moss Miami Spinal System Polyaxial Screws and Polyaxial Reduction Screws are designed to accept a 5.5mm rod and are available in various sizes.
The Moss Miami Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.
INTENDED USE: When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for deqenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle's head is formed by the silhouettes of three human faces in profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Mr. Frank Maas Regulatory Affairs Director DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K030383
Trade/Device Name: Moss Miami Spinal System - Polyaxial Screws Regulation Numbers: 21 CFR 888.3070 and 888.3050 Regulation Names: Pedicle screw spinal system and Spinal interlaminal fixation orthosis Regulatory Class: II Product Codes: MNH, MNI, and KWP Dated: January 31, 2003 Received: February 5, 2003
Dear Mr. Maas:
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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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.
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Page 2 - Mr. Frank Maas
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark n Mellersm
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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III. Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Modified Moss Miami Spinal System Polvaxial Screws Device Name:
Indications For Use:
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for deqenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 -- S1 vertebral joint, having fusions with autogenous bone graft. with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.
R. Mark N. Milkerum
Division Sign Off
reral. Restorative ... ological Devices
KO30383 510(i.) Namber -
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
DePuy AcroMed, Inc. Special 510K
N/A