(70 days)
Not Found
No
The summary describes a spinal fixation system made of standard materials and does not mention any AI or ML components, image processing, or data analysis capabilities.
Yes
The device is intended to treat various medical conditions such as scoliosis, kyphosis, lordosis, fracture, tumors, spinal stenosis, and degenerative disc disease, which are therapeutic interventions.
No
The provided text describes the intended use and indications for a spinal fixation system, which is a surgical implant used to treat various spinal conditions. It does not mention any diagnostic functions or capabilities.
No
The device description explicitly states it is manufactured from titanium alloy and stainless steel, indicating it is a hardware-based implant system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly indicate that the Moss Miami Spinal System is a surgical implant used for spinal fixation. It is designed to be surgically placed within the body to stabilize the spine and treat various spinal conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Moss Miami Spinal System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 degenerative 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.
Product codes
KWP, MNH, MNI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, L5 – S1 vertebral joint, lumbar and sacral spine (levels of pedicle screw fixation are L3 – S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Data were submitted to characterize the Moss Miami Spinal System Pin Nut.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
| K023804 | |||
|---|---|---|---|
| IX. | 510(k) Summary | Page 1 of 2 | |
| SUBMITTER: | DePuy AcroMed, Inc. | ||
| 325 Paramount Drive | |||
| Raynham, MA 02767 | JAN 23 2003 | ||
| CONTACT PERSON: | Lisa A. Gilman | ||
| DATE PREPARED: | August 2, 2002 | ||
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal | ||
| Orthosis, Spinal Pedicle Fixation | |||
| PROPRIETARY NAME: | Moss Miami Spinal System Pin Nut | ||
| PREDICATE DEVICES: | Moss Miami Spinal System Titanium Pin Nut | ||
| (K010742) | |||
| 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 | |||
| degenerative spondylolisthesis with objective | |||
| evidence of neurologic impairment, fracture, | |||
| dislocation, scoliosis, kyphosis, spinal tumor, and | |||
| failed previous fusion (pseudarthrosis). |
1
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.
MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.
PERFORMANCE
DATA:
Data were submitted to characterize the Moss Miami Spinal System Pin Nut.
KO23804 Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2003
Ms. Lisa Gilman Regulatory Affairs Associate DePuy AcroMed. Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K023804
Trade/Device Name: Moss Miami Spinal System Pin Nut Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Spondylolisthesis spinal fixation device system; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: January 6, 2003 Received: January 7, 2003
Dear Ms. Gilman:
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
3
Page 2 - Ms. Lisa Gilman
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.
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" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 A. Milburn
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
4
111. Indications for Use
510(k) Number (if known): _ KO23804
Page 1 of 1
Moss Miami Spinal System Pin Nut 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 degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Moss Miami System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 - S1 vertebral ioint, 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.
(Please do not write below this line - continue on another page if needer')
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR Over-The-Counter Use:
Mark A. Milhern
General, Restorative
Number K023804