(256 days)
DePuy Motech MOSS Spinal System, DePuy Motech MOSS Miami Spinal System, Pedicle Fixation, DePuy Motech MOSS Spinal System, Pedicle Fixation
None
No
The device description focuses solely on the mechanical components of a spinal fixation system (rods, screws, hooks, connectors). There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes.
The device is intended to treat various spinal conditions like scoliosis, kyphosis, lordosis, fracture, and degenerative disc disease, which are therapeutic interventions.
No
This device is a spinal system (MOSS Miami Spinal System) designed for the treatment of various spinal conditions through surgical fixation, not for diagnosis. Its intended use describes corrective and stabilization procedures, not diagnostic evaluation.
No
The device description explicitly details physical components made of Stainless Steel and Titanium, such as rods, screws, hooks, and connectors, which are implanted in the spine. This indicates a hardware-based medical device, not a software-only one.
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 for stabilizing the spine to treat various conditions like scoliosis, fractures, and degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details the physical components of a spinal implant system (rods, screws, hooks, etc.). These are hardware components used in surgery, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for treatment.
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 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 fixation 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 KWP
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.
The products covered in this submission are additional components to the existing MOSS Miami Spinal System and consist of: 4mm x 48cm longitudinal rods and 6mm monoaxial screws available in lengths from 25mm-55mm. All of these components are manufactured from Stainless Steel. The 6mm monoaxial screws are identical to those cleared in previous 510(k) submissions except the slot in the head is narrowed to accommodate a 4mm rod. The inner screws and outer locking nuts used to fix the monoaxial screws to the 4mm rod have also been cleared in previous 510(k) submissions.
Aside from the screws and outer locking nuts, the 4mm components described in this submission cannot be used interchangeably with the MOSS Miami 5mm rods, screws and hooks designed for use with that system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, spinal, LS-S1 vertebral joint, lumbar and sacral spine (levels of pedicle screw fixation 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)
DePuy Motech MOSS Spinal System, DePuy Motech MOSS Miami Spinal System, Pedicle Fixation, DePuy Motech MOSS Spinal System, Pedicle Fixation
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
MAR 1 8 1997
K962628 ।
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: | Rod and screw spinal instrumentation |
| CLASSIFICATION: | 888.3050 Spinal interlaminal fixation orthosis |
| DEVICE PRODUCT CODE: | Product code: 87 KWP |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | ▷ DePuy Motech MOSS Spinal System
▷ DePuy Motech MOSS Miami Spinal System,
Pedicle Fixation
▷ DePuy Motech MOSS Spinal System, Pedicle Fixation |
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.
The products covered in this submission are additional components to the existing MOSS Miami Spinal System and consist of: 4mm x 48cm longitudinal rods and 6mm monoaxial screws available in lengths from 25mm-55mm. All of these components are manufactured from Stainless Steel. The 6mm monoaxial screws are identical to those cleared in previous 510(k) submissions except the slot in the head is narrowed to accommodate a 4mm rod. The inner screws and outer locking nuts used to fix the monoaxial screws to the 4mm rod have also been cleared in previous 510(k) submissions.
Aside from the screws and outer locking nuts, the 4mm components described in this submission cannot be used interchangeably with the MOSS Miami 5mm rods, screws and hooks designed for use with that system.
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 discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
1
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 fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
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