(72 days)
No
The device description focuses on mechanical components and materials for spinal fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended to treat medical conditions such as scoliosis, kyphosis, lordosis, fractures, and degenerative disc disease, which falls under the definition of a therapeutic device.
No
The device description clearly states "The MOSS Miami Spinal System is intended for non-cervical use in the spine" and describes components for surgical implantation and stabilization (e.g., sacral extender, screws, hooks, rods). Its intended use is to treat various spinal conditions, not to diagnose them.
No
The device description clearly states it is a physical implantable device made of Ti-6Al-4V alloy, consisting of a body and an extension arm, intended for surgical implantation in the spine. This is a hardware device, 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 for spinal fixation and stabilization. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (sacral extender) made of titanium alloy, designed to be surgically attached to the spine. This is consistent with a medical device used in surgery.
- No mention of in vitro testing: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the hallmark of an in vitro diagnostic device.
- Anatomical Site: The device is used directly on the spine and iliac wings, which are internal anatomical structures. IVDs typically analyze samples taken from the body.
In summary, the MOSS Miami Spinal System and its sacral extender are surgical implants used for treating spinal conditions, not for diagnosing them through in vitro testing.
N/A
Intended Use / Indications for Use
The MOSS Miami Spinal System is intended for non-cervical use in the spine.
When used with anterior screw fixation or posterior hook, non-pedicle screw fixation 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 back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 attachment are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
Product codes (comma separated list FDA assigned to the subject device)
87 KWP, 87 KWQ, 87 MNH
Device Description
The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior serew fixation or posterior hook, non-podicic scrow fixation the MOSS Miami Spiral System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to turns. spinal stenosis, spondylolisthesis, a previously failed back surgery or degencrative disc discase (i.e. discogenic back pain with degeneration of the disc confirmed by patient listory and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in parients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusious with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw attachment are LS and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOSS Mami Spinal System is available in either Stainless Stccl or Titanium. The following components are currently available in Stainless Steel: 4 and 5mm diamotor longjudinal rods, 5-7mm diameter moroaxial screws, 5-7mm dismeter polymal scrows, hooks, trausverse comectors, axial comectors, staple washers, and sacral extenders. The following components are currently available in Tranium: 5.5mm diameter longfudinal rods, 5-8mm diameter monoaxial screws, 5-1mm diameter polyanal screws, hooks, transverse connectors, axial connectors, washers and staple washers.
This product is an addition to the existing MOSS Miami Spinal System and consists of: a sacral extender available in multiple lengths from 2cm to 20cm manufactured from Ti-6Al-4V alloy. This product uses the same inner screw and outer locking nut as the hooks and screws previously cleared in K955348 for use with the Titanium MOSS Miami Spinal System.
The sacral extender consists of a body and a longitudinal extension "arm". The body is intended to be attached to a 5.5mm MOSS Miami Titanium rod placed transversely through the iliac wings and fixed with sacral screws. The extension arm extends longitudinally and allows attachment of MOSS Miami Tranium screws or hooks. The attachment mechanism between the sacral extender body and the longitudinal rod is the same mechanism as is used for the screws and hooks in the MOSS Miami Spinal System cleared for use in K955348.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical use in the spine, L5-S1 vertebral joint, lumbar and sacral spine
Indicated Patient Age Range
Not Found
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)
Not Found
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.
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.
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
5100k) SUMMARY OF SAFETY AND ENTECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | FEB 18 19 |
| 510(K) CONTACT: | Cheryl K. Hastings
Manager, Regulatory Submissions |
| TRADE NAME: | DePuy Motech
MOSS Miami Spinal System |
| COMMON NAME: | Hook, rod and screw spinal instrumentation |
| CLASSIFICATIONS: | 888.3050 Spinal interlaminal fixation orthosis
888.3060 Spinal intervertebral body fixation orthosis
Unclassified |
| DEVICE PRODUCT CODE: | Product codes: 87 KWP, 87 KWQ, 87 MNH |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | MOSS Miami Sacral Extenders - K972568 |
DEVICE DESCRIPTION AND INTENDED USE:
The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior serew fixation or posterior hook, non-podicic scrow fixation the MOSS Miami Spiral System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to turns. spinal stenosis, spondylolisthesis, a previously failed back surgery or degencrative disc discase (i.e. discogenic back pain with degeneration of the disc confirmed by patient listory and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in parients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusious with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw attachment are LS and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOSS Mami Spinal System is available in either Stainless Stccl or Titanium. The following components are currently available in Stainless Steel: 4 and 5mm diamotor longjudinal rods, 5-7mm diameter moroaxial screws, 5-7mm dismeter polymal scrows, hooks, trausverse comectors, axial comectors, staple washers, and sacral extenders. The following components are currently available in Tranium: 5.5mm diameter longfudinal rods, 5-8mm diameter monoaxial screws, 5-1mm diameter polyanal screws, hooks, transverse connectors, axial connectors, washers and staple washers.
1
This product is an addition to the existing MOSS Miami Spinal System and consists of: a sacral extender available in multiple lengths from 2cm to 20cm manufactured from Ti-6Al-4V alloy. This product uses the same inner screw and outer locking nut as the hooks and screws previously cleared in K955348 for use with the Titanium MOSS Miami Spinal System.
The sacral extender consists of a body and a longitudinal extension "arm". The body is intended to be attached to a 5.5mm MOSS Miami Titanium rod placed transversely through the iliac wings and fixed with sacral screws. The extension arm extends longitudinally and allows attachment of MOSS Miami Tranium screws or hooks. The attachment mechanism between the sacral extender body and the longitudinal rod is the same mechanism as is used for the screws and hooks in the MOSS Miami Spinal System cleared for use in K955348.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The MOSS Miami Titanium Sacral Extender is substantially equivalent to the MOSS Miami Sacral Extender previously cleared in K972568 in that they have similar designs and the same intended use. The only differences between the MOSS Miami Titanium Sacral Extenders described in this submission, and the predicate MOSS Miami Sacral Extenders are: 1) a change in material from stainless steel to titanium alloy and 2) slight dimensional changes (increases in the extender ann diameter and the slot width from 5.0mm to accomodate use with the MOSS Miami Titanium system).
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Ms. Cheryl K. Hastings ·Manager, Regulatory Submissions DePuy® Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K974573 Re : Titanium Sacral Extender to be used as part of the MOSS-Miami Spinal System Requlatory Class: II Product Codes: MNH, KWP, and KWQ Dated: December 5, 1997 Received: December 8, 1997
Dear Ms. Hastings:
We have reviewed your Section 510 (k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act) . . found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid You may, therefore, market your device system fusion mass. subject to the general controls provisions of the Act and the limitations identified below.
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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.
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Page 2 - Ms. Cheryl K. Hastings
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III Class III devices are device under Section 513 (f) of the Act. required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for Ditients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using vercebrar joine, (b) mio are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- When used as a pedicle screw system, this device ● system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended ● for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- Benefit of spinal fusions utilizing any pedicle ● screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this ● device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and ..................................................................................................................................................... vascular or visceral injury.
4
Page 3 - Ms. Cheryl K. Hastings
See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption All users of (IDE) regulations under 21 CFR, Part 812. the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investiqation.
- Any previous warning statements identified as part of 4. previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above .
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 requlations 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 In addition, FDA may publish further announcements action. 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.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
5
Page 4 - Ms. Cheryl K. Hastings
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
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
6
510(k) Number (if known)K974573
DePuy Motech MOSS Miami Titanium Sacral Extender Device Name
Indications for Use:
The MOSS Miami Spinal System is intended for non-cervical use in the spine.
When used with anterior screw fixation or posterior hook, non-pedicle screw fixation 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 back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 attachment are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
Concurrence of CDRH, Office of Device Evaluation
signature
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use
Over-The Counter Use OR (Per 21 CFR 801.109)