(20 days)
Not Found
No
The document describes a spinal fixation system made of standard materials and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is intended to treat various medical conditions such as scoliosis, kyphosis, lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, failed fusion surgery, and degenerative disc disease. This indicates its use for therapeutic purposes.
No
The text describes a spinal fixation system (Moss Miami Spinal System) used for treating various spinal conditions, not for diagnosing them. It is an implant designed for treatment through stabilization and fusion.
No
The device description explicitly states it is manufactured from titanium and stainless steel, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system used for spinal fixation to treat various conditions like scoliosis, fractures, tumors, etc. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and type of screws used in the system, which are components of a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for diagnosis.
- Anatomical Site: The device is used within the body (spine), which is typical for a surgical implant, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is clearly used in vivo (within the body) for structural support and stabilization.
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 (comma separated list FDA assigned to the subject device)
MNH, MNI, KWP
Device Description
Manufactured from ASTM F-136 implant grade titanium alloy, ASTM F-1314 implant grade stainless steel, and ASTM F-138 implant grade stainless steel.
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 5.0mm diameter Polyaxial Screws (Moss Miami 6.35mm System.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Moss Miami Spinal System (K983583, K992168 & K002607)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
IX. 510(k) Summary
| SUBMITTER: | DePuy AcroMed, Inc.
325 Paramount Drive
Raynham, MA 02767 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | August 2, 2002 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal
Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | 5.0mm Diameter Polyaxial Screws for the Moss Miami
6.35mm System |
| PREDICATE DEVICES: | Moss Miami Spinal System (K983583, K992168 &
K002607) |
| 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 |
1/2
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.
K (12262
- Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy, ASTM F-1314 implant grade stainless steel, and ASTM F-138 implant grade stainless steel.
PERFORMANCE DATA:
Data were submitted to characterize the 5.0mm diameter Polyaxial Screws (Moss Miami 6.35mm System.)
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol features three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line, creating a sense of unity and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2002
Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767
K022623 Re:
Trade/Device Name: 5.0mm Diameter Polyaxial Screws (Moss Miami 6.35mm System) Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: August 2, 2002 Received: August 7, 2002
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.
3
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 and additionally 21 CFR Part 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" (21CFR Part 807.97), 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.
L. Mark N. Millhussen
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
Indications for Use III.
510(k) Number (if known): _ KO22623___________________________________________________________________________________________________________________________________________
5.0mm diameter Polyaxial Screws (Moss Miami 6.35mm Device Name: System)
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.
(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) |
for Mark N Millanzo
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022623 |
|---|---|
| --------------- | --------- |