DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

K980447 · DePuy Orthopaedics, Inc. · MNH · Apr 14, 1998 · Orthopedic

Device Facts

• Record ID: K980447
• Device Name: DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Apr 14, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• 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 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 Story

MOSS Miami Spinal System is a rod-and-screw spinal instrumentation set. This submission adds 6mm diameter components (longitudinal rods, monoaxial/polyaxial screws, hooks, connectors) to the existing system. Components are manufactured from stainless steel or titanium. Used by orthopedic surgeons in clinical settings to provide spinal stabilization. System components are implanted to treat various spinal pathologies; pedicle screw use is strictly limited to severe L5-S1 spondylolisthesis. Surgeons attach longitudinal rods to the spine using screws, hooks, and connectors to provide structural support during bone fusion. The device is intended to be removed after solid fusion mass development. Benefits include stabilization of the spinal column; risks include component fracture, loss of fixation, non-union, and neurological/vascular injury.

Clinical Evidence

Bench testing only. Mechanical testing was performed to compare the biomechanical performance of the 6 mm system components and subconstructs against existing MOSS Miami systems and competitive spinal systems, demonstrating similar performance.

Technological Characteristics

Materials: Stainless steel or titanium. Components: 6 mm diameter longitudinal rods, monoaxial/polyaxial screws, hooks, transverse/axial connectors, washers. Principle: Spinal interlaminal fixation orthosis. Connectivity: None. Software: None.

Indications for Use

Indicated for non-cervical spinal stabilization. Treats scoliosis, kyphosis, lordosis, fracture, tumor-related instability, spinal stenosis, spondylolisthesis, failed back surgery, or degenerative disc disease. Pedicle screw fixation restricted to patients with severe (Grade 3-4) L5-S1 spondylolisthesis requiring autogenous bone graft fusion, with fixation at L3 or below and planned device removal post-fusion.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• DePuy Motech MOSS Miami Spinal System (K980447)
• Sofamor Danek TSRH Spinal System

Submission Summary (Full Text)

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APR 1 4 1998

510(k) SUMMARY OF SAFETY AND EFFE

K980447

| NAME OF FIRM: | DePuy Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Lynnette Whitaker<br>Manager, Clinical and Regulatory 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<br>EQUIVALENT DEVICES: | DePuy Motech MOSS Miami Spinal System.<br>DePuy Motech MOSS Miami Spinal System,<br>Pedicle Fixation<br>DePuy Motech MOSS Miami Spinal System, Anterior<br>Use,<br>DePuy Motech MOSS Miami Spinal System, 4mm rod,<br>Sofamor Danek TSRH Spinal System. |

## 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: 4 and 5mm diameter longitudinal rods. 5-7 mm diameter monoaxial screws. 5-7 mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5 mm diameter longitudinal rods, 5-8 mm diameter monoaxial screws, 5-7 mm diameter polyaxial screws, hooks, tranverse connectors, axial connectors, washers and staple washers.

The products in this submission are additional components to the existing MOSS Miami Spinal System. The MOSS Miami 6 mm Sub-System consists of: 6 mm diameter longitudinal rods in lengths of 12, 30 and 48cm; axial and transverse connectors for joining longitudinal rods; 6mm and 7mm diameter mono- and polyaxial screws in various lengths, which are attached to the longitudinal rods with inner screws and outer nuts; and various hooks and other accessories. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.

The MOSS Miami Spinal System is intended for non-cervical use in the sp RTHOPAEDIC DRIVE • P.O. BOX 988 •

WARSAW, IN 46581-0988

000011

TELEPHONE [phone]

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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 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.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the MOSS Miami 6.0 mm Spinal System are identical to the components of the other MOSS Miami Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications. The only differences between the two systems is in the diameter of the longitudinal rods, which is 6 mm instead of 5 mm.

Mechanical testing shows that the biomechanical performance of the components and subconstructs of the MOSS Miami 6 mm Spinal System is expected to be similar to the performance of the other MOSS Miami Spinal Systems and competitive spinal systems.

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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 stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 4 1998

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

Re : K980447 MOSS Miami Spinal System - 6.0mm System II Requlatory Class: Product Codes: MNH, KWP and KWQ February 3, 1998 Dated: Received: February 5, 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, Druq, and Cosmetic Act This decision is based on your device system being (Act). 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 reqistration, 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.

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than

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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:

- All labeling for this device, including the package 1. 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 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 not label or in anyway promote this device system 2. 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.

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

- Any pedicular screw fixation/attachment for intended uses 3. 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.
- Any previous warning statements identified as part of 4 . 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) 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.

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Page 4 - Ms. Lynnette Whitaker

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 diaqnostic 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" (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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stephen Rhodes

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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510(k) Number (if known) _K 98 0 44 7

DePuy Motech MOSS Miami Spinal System Device Name

Indications for 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 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.

Concurrence of CDRH, Office of Device Evaluation

Stuton Rhodes

Division of General Restorative Device K980447 510(k) Number

Prescription Use X OR (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

0000003