Who is the manufacturer of MOSS MIAMI SPINAL SYSTEM?

Depuy, Inc. filed the 510(k) submission for MOSS MIAMI SPINAL SYSTEM (K962628).

What is the FDA product code for MOSS MIAMI SPINAL SYSTEM?

KWP. It is classified under 21 CFR 888.3050 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for MOSS MIAMI SPINAL SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MOSS MIAMI SPINAL SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MOSS MIAMI SPINAL SYSTEM

Q: What are the predicate devices for MOSS MIAMI SPINAL SYSTEM?

DePuy Motech MOSS Spinal System; DePuy Motech MOSS Miami Spinal System, Pedicle Fixation; DePuy Motech MOSS Spinal System, Pedicle Fixation.

K962628 · Depuy, Inc. · KWP · Mar 18, 1997 · Orthopedic

Device Facts

Record ID	K962628
Device Name	MOSS MIAMI SPINAL SYSTEM
Applicant	Depuy, Inc.
Product Code	KWP · Orthopedic
Decision Date	Mar 18, 1997
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3050
Device Class	Class 2
Attributes	Therapeutic

Intended 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 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, monoaxial screws, polyaxial screws, hooks, transverse/axial connectors, and washers. Components fabricated from stainless steel or titanium. System provides mechanical stabilization of spinal segments to facilitate fusion. Used by orthopedic or neurosurgeons in surgical settings. Input: surgical site anatomy; Output: rigid construct providing structural support. Benefits: correction of spinal deformities, stabilization of fractures, and management of degenerative conditions. This submission adds 4mm diameter rods and 6mm monoaxial screws to existing system; screw head slots narrowed to fit 4mm rods.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and mechanical performance characteristics.

Technological Characteristics

Materials: Stainless steel or titanium. Components: Longitudinal rods, monoaxial/polyaxial screws, hooks, connectors, washers. Design: Mechanical spinal interlaminal fixation orthosis. Connectivity: None. Software: None.

Indications for Use

Indicated for non-cervical spinal stabilization in patients with 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, requiring autogenous bone graft fusion, with fixation at L3 and below; device removal intended post-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 Spinal System
DePuy Motech MOSS Miami Spinal System, Pedicle Fixation
DePuy Motech MOSS Spinal System, Pedicle Fixation

Related Devices

K040072 — MODIFICATION TO CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek, Inc. · Feb 12, 2004
K200245 — EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System · Medos International Sàrl · Apr 24, 2020
K161535 — SeaSpine® NewPort Spinal System · SeaSpine Orthopedics Corporation · Sep 8, 2016
K041460 — CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek USA, Inc. · Jul 1, 2004
K113174 — CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek USA, Inc. · Nov 21, 2011

Submission Summary (Full Text)

{0} K962628 MAR 18 1997 1 of 2 # 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 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). {1} K962628 2of2 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.