(170 days)
No
The summary describes a spinal implant system composed of rods, screws, hooks, and connectors. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The description explicitly states the device is intended to treat medical conditions such as scoliosis, kyphosis, lordosis, fractures, spinal stenosis, and spondylolisthesis, which falls under the definition of a therapeutic device.
No
The text describes a spinal system intended to treat various spinal conditions, not to perform diagnosis. It's a surgical implant, not a diagnostic tool.
No
The device description explicitly lists physical components made of Stainless Steel and Titanium, such as rods, screws, hooks, and connectors. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, 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 treat various spinal conditions by providing stability and facilitating fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The device components are described as rods, screws, hooks, and connectors, which are all physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 turnor, 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 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
KWP, KWQ, MNH
Device Description
The MOSS Miami Spinal System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: 4mm and 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 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.
Titanium components of the MOSS Miami Spinal System were cleared in K955348 for the intended uses listed above. The components that were cleared included 5.5mm longitudinal smooth rods, 6 and 7mm diameter mono- and polyaxial screws, inner screws, outer locking nuts, washers, staple washers, hooks, transverse connectors and axial connectors. Additional screws with diameters of 5mm and 8mm are now being added to this system. These additional components are intended to be used with the Titanium MOSS Miami rods, hooks, screws, transverse and axial connectors and outer locking nut which have previously been described and cleared for marketing 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 (levels of pedicle screw attachment are L3 and below)
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)
Reference Device(s)
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
510(k) SUMMARY
AR 26 por
DePuy Inc. NAME OF FIRM: 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Cheryl Hastings 510(K) CONTACT: Manager, Clinical Affairs DePuy Motech MOSS Miami Spinal System TRADE NAME: COMMON NAME: Rod and screw spinal instrumentation 888.3050 Spinal interlaminal fixation orthosis CLASSIFICATION: 87 KWP, KWQ and MNH DEVICE PRODUCT CODE: DePuy Motech MOSS Miami Spinal System - Titanium SUBSTANTIALLY Components > DePuy Motech MOSS Miami Spinal System EQUIVALENT DEVICES: - Anterior Use
INTENDED USE AND DEVICE DESCRIPTION:
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 turnor, 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 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.
The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: 4mm and 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 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.
Titanium components of the MOSS Miami Spinal System were cleared in K955348 for the intended uses listed above. The components that were cleared included 5.5mm longitudinal smooth rods, 6 and 7mm diameter mono- and polyaxial screws, inner screws, outer locking nuts, washers, staple washers, hooks, transverse connectors and axial connectors. Additional screws with diameters of 5mm and 8mm are now being added to this system. These additional components are intended to be used with the Titanium
1
MOSS Miami rods, hooks, screws, transverse and axial connectors and outer locking nut which have previously been described and cleared for marketing in K955348.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The 5 and 8mm diameter Titanium MOSS Miami screws are substantially equivalent to the screws originally cleared in K955348 (6 and 7mm diameter) in that they are manufactured from the same material, have the same intended use and have basically the same design. The only differences between the screws previously cleared and the screws that are the submission are that the 5mm screws have slightly shorter threads than the 6mm screws (but the same minor diameter) and the 8mm screws have a slightly larger diameter than the 7mm Titanium screws have the same design as the 5mm Stainless Steel screws that were cleared in K953915.