DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

K965145 · Depuy, Inc. · KWP · Mar 13, 1997 · Orthopedic

Device Facts

• Record ID: K965145
• Device Name: DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
• Applicant: Depuy, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MOSS Miami Spinal System, with either the existing smooth rods or the subject ratchet rods, 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 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 fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

Device Story

Spinal fixation system consisting of longitudinal rods, hooks, and screws; used for non-cervical spinal stabilization. Subject device adds 5mm diameter cold-worked 'ratchet' rods to existing Stainless Steel MOSS Miami system. Ratchet design features ringed surface to facilitate intraoperative positioning of hooks and screws; allows initial loose placement and ratcheting to final position versus repeated loosening/tightening required by smooth rods. System components are implanted by surgeons during spinal fusion procedures. Ratchet rods maintain compatibility with previously cleared MOSS Miami hooks, screws, and locking nuts. Benefits include improved surgical efficiency and ease of adjustment during construct assembly.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing comparing static and fatigue strength of ratchet rods to predicate smooth rods.

Technological Characteristics

Materials: Stainless Steel. Components: 5mm diameter longitudinal ratchet rods, hooks, monoaxial/polyaxial screws, transverse/axial connectors, washers. Design: Cold-worked ringed surface for ratchet mechanism. Non-active, mechanical spinal fixation system.

Indications for Use

Indicated for non-cervical spinal treatment of scoliosis, kyphosis, lordosis, fracture, tumor-related instability, spinal stenosis, spondylolisthesis, failed back surgery, or degenerative disc disease. Pedicle screw fixation indicated specifically for severe spondylolisthesis (Grades 3-4) at L5-S1 with autogenous bone graft, fixed at L3 or below, intended for removal after fusion.

Regulatory Classification

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.

Predicate Devices

• DePuy Motech MOSS Miami Spinal System (K965145)
• DePuy Motech MOSS Miami Spinal System, Pedicle Fixation (K965145)
• DePuy Motech MOSS Miami Spinal System - Anterior Use (K965145)

Submission Summary (Full Text)

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# 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
- Anterior Use |

## 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 30cm and 5mm x 48cm longitudinal ratchet rods to the Stainless Steel MOSS Miami Spinal System. The ratchet 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 L5-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 surface.

The ratchet rod system was designed to make interoperative adjustments of components 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 the rod and then must be repeatedly loosened, moved and re-tightened until final positioning is accomplished.

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K965145
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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 ratchet rods, 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 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 fixation 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.