DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS

K983583 · Depuy, Inc. · KWP · Dec 3, 1998 · Orthopedic

Device Facts

• Record ID: K983583
• Device Name: DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
• Applicant: Depuy, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Dec 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, 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 fusion surgery or degenerative disc disease (i.e. discogenic; back pain with degeneration of the disc confirmed by patient history and radiographic studies). When used as a pedicle screw fixation system of the noncervical spine in skeletally matrue patients, the MOSS Miami System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MOSS Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature 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

MOSS Miami Spinal System is a rod and screw spinal instrumentation set; components include longitudinal rods, monoaxial/polyaxial/reduction screws, hooks, transverse/axial connectors, washers, and sacral extenders. Available in stainless steel or titanium. Used by surgeons in clinical settings to treat spinal pathologies including scoliosis, kyphosis, lordosis, fractures, tumors, and degenerative disc disease. System provides mechanical stabilization of the spine to facilitate fusion. Components are implanted to provide structural support; intended for removal after solid fusion mass development in specific severe spondylolisthesis cases.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material identity to previously cleared predicate devices.

Technological Characteristics

System components include longitudinal rods, monoaxial/polyaxial/reduction screws, hooks, transverse/axial connectors, washers, and sacral extenders. Materials: Stainless steel or titanium. Mechanical fixation system; no software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal fixation for degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion, or severe spondylolisthesis (Grades 3-4) at L5-S1.

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 (for posterior use)
• DePuy Motech MOSS Miami Spinal System -Pedicle Fixation
• DePuy Motech MOSS Miami Spinal System anterior indications
• DePuy Motech MOSS Miami 4.0 mm Rod Spinal Subsystem
• DePuy Motech Universal Spinal System and Transverse Rod Stabilizer
• Biedermann Motech MOSS Miami Spinal System, 6.0mm Rod Subsystem
• DePuy Motech Titanium MOSS Miami Spinal System
• DePuy Motech MOSS Miami Spinal System Ratchet Rods
• DePuy Motech MOSS Miami Titanium Sacral Extenders

Submission Summary (Full Text)

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K983583

Image /page/0/Picture/27 description: The image shows the logo for DePuy AcroMed. The logo consists of a black circle on the left, followed by the text "DePuyAcroMed" in a stylized font. The letters are connected and have a slightly rounded appearance. To the right of the text, there is a small "TM" symbol, indicating a trademark.

DEC 3 1998

13 Carnenie Ave

510(k) SUMMARY OF SAFETY AND EFFF

Lynnette Whitaker

Tel: [phone]
Fax: [phone]

NAME OF FIRM:

DePuy Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

510(K) CONTACT:

TRADE NAME:

COMMON NAME:

CLASSIFICATION:

888.3050 Spinal interlaminal fixation orthosis 888.3070 Pedicle screw spinal system 888.3060 Spinal intervertebral body fixation orthosis

Manager, Clinical and Regulatory Affairs

Rod and screw spinal instrumentation

DePuy AcroMed MOSS Miami Spinal System

DEVICE PRODUCT CODE:

Product code: 87KWP 87MNH 87MNI 87KWQ

SUBSTAINTIALLY EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal System (for posterior use)

DePuy Motech MOSS Miami Spinal System -Pedicle Fixation

DePuy Motech MOSS Miami Spinal System anterior indications

DePuy Motech MOSS Miami 4.0 mm Rod Spinal Subsystem

DePuy Motech Universal Spinal System and Transverse Rod Stabilizer

Biedermann Motech MOSS Miami Spinal System, 6.0mm Rod Subsystem

DePuy Motech Titanium MOSS Miami Spinal System

DePuy Motech MOSS Miami Spinal System Ratchet Rods

DePuy Motech MOSS Miami Titanium Sacral Extenders

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## DEVICE DESCRIPTION AND INTENDED USE:

The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.

When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, 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 fusion surgery or degenerative disc disease (i.e. discogenic; back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally matrue patients, the MOSS Miami System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature 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 components of the MOSS Miami Spinal System are identical to the components of the other MOSS Miami Spinal Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 3 1998

Ms. Lynnette Whitaker Manager, Clinical and Regulatory Affairs DePuy Motech AcroMed, Inc. 3303 Carnegie Avenue Cleveland, Ohio 44115

Re: K983583 MOSS® Miami Spinal System - expanded uses Regulatory Class: II Product Codes: MNI, KWP, KWQ, and MNH Dated: October 9, 1998 Received: October 13, 1998

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lynnette Whitaker

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Page 2 - Ms. Lynnette Whitaker

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure