MOSS MIAMI SPINAL SYSTEM PIN NUT

K023804 · Depuyacromed · KWP · Jan 23, 2003 · Orthopedic

Device Facts

• Record ID: K023804
• Device Name: MOSS MIAMI SPINAL SYSTEM PIN NUT
• Applicant: Depuyacromed
• Product Code: KWP · Orthopedic
• Decision Date: Jan 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a posterior, noncervical hook, and/or sacral/iliac 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 mature patients, the Moss Miami Spinal 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 – S1), and for whom the device system is intended to be removed after solid fusion is attained.

Device Story

The Moss Miami Spinal System Pin Nut is a spinal fixation component used by surgeons in clinical settings to secure spinal constructs. It functions as part of a larger system of hooks, screws, and rods to stabilize the spine. The device is implanted to treat various spinal pathologies, including deformities and fractures, by providing rigid fixation to facilitate fusion. The pin nut secures the construct, maintaining alignment and stability during the healing process. It is intended for use in the noncervical spine. The system is designed for removal after solid fusion is achieved in specific severe spondylolisthesis cases. Benefits include stabilization of the spinal column, correction of deformities, and support for bone graft healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manufactured from ASTM F-136 implant-grade titanium alloy and ASTM F-138 implant-grade stainless steel. The device is a mechanical fixation component (pin nut) for a spinal orthosis system. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal fixation for scoliosis, kyphosis, lordosis, fracture, tumor-related instability, spinal stenosis, spondylolisthesis, failed fusion, or degenerative disc disease. Specific pedicle screw indications include severe spondylolisthesis (Grades 3-4) at L5-S1 with autogenous bone graft.

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

• Moss Miami Spinal System Titanium Pin Nut (K010742)

Submission Summary (Full Text)

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| | | | K023804 |
|-----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| IX. | 510(k) Summary | | Page 1 of 2 |
| | SUBMITTER: | DePuy AcroMed, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | JAN 23 2003 |
| | CONTACT PERSON: | Lisa A. Gilman | |
| | DATE PREPARED: | August 2, 2002 | |
| | CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation | |
| | PROPRIETARY NAME: | Moss Miami Spinal System Pin Nut | |
| | PREDICATE DEVICES: | Moss Miami Spinal System Titanium Pin Nut<br>(K010742) | |
| | INTENDED USE: | When used as a posterior, noncervical hook, and/or<br>sacral/iliac screw fixation system, or as an anterior,<br>thoracic/lumbar screw fixation system, the Moss<br>Miami Spinal System is intended to treat scoliosis,<br>kyphosis and lordosis, fracture, loss of stability due to<br>tumor, spinal stenosis, spondylolisthesis, a previously<br>failed fusion surgery or degenerative disc disease<br>(i.e., discogenic back pain with degeneration of the<br>disc confirmed by patient history and radiographic<br>studies). | |
| | | When used as a pedicle screw fixation system of the<br>noncervical spine in skeletally mature patients, the<br>Moss Miami Spinal System is indicated for<br>degenerative spondylolisthesis with objective<br>evidence of neurologic impairment, fracture,<br>dislocation, scoliosis, kyphosis, spinal tumor, and<br>failed previous fusion (pseudarthrosis). | |

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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 – S1), and for whom the device system is intended to be removed after solid fusion is attained.

MATERIALS:

Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.

## PERFORMANCE

DATA:

Data were submitted to characterize the Moss Miami Spinal System Pin Nut.

> KO23804 Page 2 of 2

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2003

Ms. Lisa Gilman Regulatory Affairs Associate DePuy AcroMed. Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K023804

Trade/Device Name: Moss Miami Spinal System Pin Nut Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Spondylolisthesis spinal fixation device system; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: January 6, 2003 Received: January 7, 2003

Dear Ms. Gilman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 - Ms. Lisa Gilman

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 111. Indications for Use

510(k) Number (if known): _ KO23804

Page 1 of 1

Moss Miami Spinal System Pin Nut Device Name:

Indications For Use:

When used as a posterior, noncervical hook, and/or sacral/iliac 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 mature patients, the Moss Miami Spinal 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 System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 - S1 vertebral ioint, 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 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR Over-The-Counter Use:

Mark A. Milhern

General, Restorative

Number K023804