(87 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a spinal system intended to treat various spinal conditions such as scoliosis, kyphosis, fracture, tumor, and degenerative disc disease, indicating its use in managing and alleviating medical conditions.
No
Explanation: The provided text describes a "Moss Miami Spinal system" which is a fixation system (screws and rods) intended to treat various spinal conditions. It is a surgical implant designed for treatment, not for diagnosing conditions.
No
The device description clearly indicates it is a physical implant (screws) made of titanium alloy or stainless steel, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to stabilize the spine for various conditions like scoliosis, fractures, tumors, etc. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as screws made of titanium alloy or stainless steel, designed to be implanted in the spine. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Moss Miami Spinal system is a surgical implant device, not an In Vitro Diagnostic device.
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
87/KWP, 87/MNH, 87/MNH, 87/KWR, KWQ, KWP, MNH, MNI
Device Description
The Moss Miami 6.35mm Polyaxial screws described in this submission are modifications of the previously cleared Moss Miami Polyaxial Screws. The head portion of the screw has been increased to allow the placement of a 6.35mm (1/4 inch) rod. The modified screws are available in the same thread diameters and lengths as the existing screws, namely 6.0mm, 7.0mm, and 8.0mm diameters and 30mm to 55mm lengths.
The 6.35mm polyaxial screws are manufactured from either implant grade titanium alloy or stainless steel that conform to ASTM standards F-136 and F-138, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical, sacral/iliac, anterior, thoracic/lumbar, spine, 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)
Testing was presented to evaluate the performance characteristics of the modified polyaxial screws. Specific tests of the construct included static tests in compression bending and torsion, and fatique testing in compression bending.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983583, K953882, K950697, K933881, K964024, K955348
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP 2 3 1999
510(k) Summary
Proprietary name: Moss Miami 6.35mm Polyaxial Screw
Common Name: Polvaxial Pedicle Screw
Classification Name and Reference:
Spinal interlaminal fixation orthosis, §888.3050 Pedicle screw spinal fixation §888.3070
Proposed Requiatory Class: Class II
Device Product Code: 87/KWP, 87/MNH, 87/MNH, 87/KWR
The Moss Miami 6.35mm Polyaxial screws described in this submission are modifications of the previously cleared Moss Miami Polyaxial Screws. The head portion of the screw has been increased to allow the placement of a 6.35mm (1/4 inch) rod. The modified screws are available in the same thread diameters and lengths as the existing screws, namely 6.0mm, 7.0mm, and 8.0mm diameters and 30mm to 55mm lengths.
The 6.35mm polyaxial screws are manufactured from either implant grade titanium alloy or stainless steel that conform to ASTM standards F-136 and F-138, respectively.
Testing was presented to evaluate the performance characteristics of the modified polyaxial screws. Specific tests of the construct included static tests in compression bending and torsion, and fatique testing in compression bending.
The substantial equivalence of the modified Polyaxial screws is based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Moss Miami Polyaxial Screw System (K983583, K953882, K950697 and K933881 (stainless steel) and K983583, K964024, K955348 (titanium alloy).
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right.
SEP 2 3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Manager, Regulatory Affairs DePuy AcroMed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K992168 Trade Name: Moss Miami 6.35mm Polyaxial Screw to be used with the Moss Miami Spinal System Regulatory Class: II Product Code: KWQ, KWP, MNH and MNI Dated: June 24, 1999 Received: June 28, 1999
Dear Mr. Maas:
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 (OS) 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 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 - Mr. Frank Maas
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K992168
Device Name: Moss Miami Spinal 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
| (per 21 CRF 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K992168 |
|---|---|
| --------------- | --------- |