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 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 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 Description

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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the results of a study to prove a device meets those criteria. The document is a 510(k) summary for a spinal system (MOSS Miami Spinal System) and primarily discusses its description, intended use, and substantial equivalence to previously cleared devices. It also outlines the FDA's decision regarding its marketing, including specific limitations and warnings related to pedicle screw fixation.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

Summary

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K982320

Image /page/0/Picture/1 description: The image shows the logos of two companies, DePuy Motech and AcroMed. The DePuy Motech logo is on top, and the AcroMed logo is below it. The logos are both in a sans-serif font and are outlined in black. The DePuy Motech logo also has a circle to the left of the company name.

510(k) SUMMARY OF SAFETY AND EFFECT

DePuy Inc.

DePuy Motech AcroMe

EXHIBIT G

NAME OF FIRM:

SEP 1 4 1998

510(K) CONTACT:

Lynnette Whitaker Manager, Clinical and Regulatory Affairs

700 Orthopaedic Drive Tel: +1 (216) 43 700 Orthopacche Dirve fanggo 216, 432 699

TRADE NAME:

COMMON NAME:

DEVICE PRODUCT CODE AND CLASSIFICATION:

SUBSTANTIALLY

EQUIVALENT DEVICES:

Lynnette Whitaker
Manager, Clinical and Regulatory Affairs

DePuy Motech MOSS Miami Spinal System

Rod and screw spinal instrumentation

87 KWP, Classification 888.3050 87 KWO. Classification 888.3060 87 MNH, Class II

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 4.0mm Spinal System,

DePuy Motech Universal Spinal System and Transverse Rod Stabilizer

Beidermann Motech MOSS Miami 6.0mm Spinal Systèm

DEVICE DESCRIPTION AND INTENDED USE:

The MOSS Miami Spinal System is intended for non-cervical use in the spine.

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J. J. Thomson on the "Size" of an Electron

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 features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Ms. Lynnette Whitaker Manager, Clinical and Regulatory Affairs DePuy Motech Acromed, Inc. 700 Orthopedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K982320 MOSS® Miami Spinal System - Additional Screws and Connectors Regulatory Class: II Product Codes: MNH, KWP, and KWO Dated: June 29, 1998 Received: July 2, 1998

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f)(1) of the Act.

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Page 2 - Ms. Lynnette Whitaker

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1. All labeling for this device, including the package label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral ioint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
1. You may not label or in anyway promote this device system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

WARNINGS:

. When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
. The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
. Potential risks identified with the use of this device system, which may require additional surgery, include:
- device component fracture, loss of fixation. non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

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Page 3 - Ms. Lynnette Whitaker

1. Any pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
1. Any previous warning statements identified as part of previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.

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 requirement, as set forth in the Quality System Regulation (QS) 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.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket

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Page 4 - Ms. Lynnette Whitaker

notification" (21 CFR 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 (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/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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EXHIBIT A

510(k) Nun:ber 982320

DePuy Motech MOSS Miami 4.0mm Spinal System, Additional Device Name Components

Indications for Use:

The MOSS Miami Spinal System is intended for non-cervical use in the spine.

Concurrence of CDRH, Office of Device Evaluation
--------------------------------------------------

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	12982320

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

Regulation Number and Section

§ 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.