(80 days)
KWP, KWQ, MNH
Not Found
No
The document describes a mechanical spinal system with ratchet rods, focusing on material, design, and ease of use during surgery. There is no mention of AI or ML technology.
Yes.
The device is intended to treat various spinal conditions such as scoliosis, kyphosis, lordosis, fractures, and degenerative disc disease, which are therapeutic indications.
No
The device is described as a spinal system for non-cervical use, including rods, screws, and other components, intended for treating various spinal conditions and for spinal fusion. It is a surgical implant designed for mechanical stability and fusion, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of Stainless Steel and Titanium, such as rods, screws, hooks, and connectors, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the MOSS Miami Spinal System is a collection of implants (rods, screws, hooks, connectors) made of Stainless Steel or Titanium. These are surgically implanted into the spine.
- Intended Use: The intended use describes the surgical treatment of various spinal conditions by providing stability and support. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for spinal fixation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MOSS Miami Spinal System, with either the existing smooth rods or the subject ratcher rods, is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, nonpedicle screw fixation the MOSS Miam Spinal System is intended to treat scobosis, 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 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 LS-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 fration 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
87 KWQ, KWP, MNH
Device Description
The MOSS MIAMI Spinal System is available in either Stainless Steel or Titanium. The following components are currently available in Stainless Steel: 5mm diameter longitudinal rods, 5-7mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5mm diameter longitudinal rods, 5-8mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers.
This submission describes the addition of 5mm x 12cm, 5mm x 48cm longitudinal ratchet rods to the Stainless Steel MOSS Miami Spinal System. The ratcher rods are similar to the MOSS Miami 5.0mm smooth longitudinal rods that have been previously cleared for anterior, posterior non-pedicle use and posterior pedicle fixation (Grades III or IV spondylolisthesis at LS-S1). The ratchet rods are manufactured from the same material and have the same lengths as the previously cleared, smooth, longitudinal rods. The only difference in design between the subject ratchet rods and the previously cleared, smooth, longitudinal rods is that the ratchet rods are cold-worked, creating a ringed outer suface.
The ratcher rod system was designed to make interoperative adjustments easier and quicker than with the smooth rod system When the ratchet rods are used, hooks and screws can be initially positioned on the rod and held in place with a loose connection, then ratcheted into final position and tightened. With the smooth rods, components are tightened onto then must be repeatedly loosened, moved and re-tightened until final positioning is accomplished.
The 5mm ratchet rods described in this submission are intended to be used with the existing MOSS Miami Stainless Steel hooks, screws, inner screw and outer locking nut which have previously been cleared for marketing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, non-cervical, Lumbar and sacral spine (L3 and below), LS-S1 vertebral joint
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)
Not Found
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
Kassius 1 of 2
MAR | 3 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs |
| TRADE NAME: | DePuy Motech MOSS Miami Spinal System |
| COMMON NAME: | Hook, rod and screw spinal instrumentation |
| CLASSIFICATION: | 888.3050 Spinal interlaminal fixation orthosis |
| DEVICE PRODUCT CODES: | 87 KWQ, KWP, MNH |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | ⇒ DePuy Motech MOSS Miami Spinal System
⇒ DePuy Motech MOSS Miami Spinal
System, Pedicle Fixation
⇒ DePuy Motech MOSS Miami Spinal System |
DEVICE DESCRIPTION AND INTENDED USE:
The MOSS MIAMI Spinal System is available in either Stainless Steel or Titanium. The following components are currently available in Stainless Steel: 5mm diameter longitudinal rods, 5-7mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5mm diameter longitudinal rods, 5-8mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers.
This submission describes the addition of 5mm x 12cm, 5mm x 48cm longitudinal ratchet rods to the Stainless Steel MOSS Miami Spinal System. The ratcher rods are similar to the MOSS Miami 5.0mm smooth longitudinal rods that have been previously cleared for anterior, posterior non-pedicle use and posterior pedicle fixation (Grades III or IV spondylolisthesis at LS-S1). The ratchet rods are manufactured from the same material and have the same lengths as the previously cleared, smooth, longitudinal rods. The only difference in design between the subject ratchet rods and the previously cleared, smooth, longitudinal rods is that the ratchet rods are cold-worked, creating a ringed outer suface.
The ratcher rod system was designed to make interoperative adjustments easier and quicker than with the smooth rod system When the ratchet rods are used, hooks and screws can be initially positioned on the rod and held in place with a loose connection, then ratcheted into final position and tightened. With the smooth rods, components are tightened onto then must be repeatedly loosened, moved and re-tightened until final positioning is accomplished.
1
K965145 2.62
The 5mm ratchet rods described in this submission are intended to be used with the existing MOSS Miami Stainless Steel hooks, screws, inner screw and outer locking nut which have previously been cleared for marketing.
The MOSS Miami Spinal System, with either the existing smooth rods or the subject ratcher rods, is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, nonpedicle screw fixation the MOSS Miam Spinal System is intended to treat scobosis, 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 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 LS-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 fration are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The MOSS Miami 5mm Ratchet Rod is substantially equivalent to the MOSS Miami 5mm smooth rod that has been previously cleared for posterior non-pedicle use, limited posterior pedicle fixation and anterior use. This substantial equivalence is based on similar designs, similar interconnection mechanisms, identical materials, comparable static and fatigue strength and identical indications for use.