MODIFICATION TO EXPEDIUM SPINE SYSTEM

K062174 · Depuy Spine, Inc. · MNH · Nov 2, 2006 · Orthopedic

Device Facts

• Record ID: K062174
• Device Name: MODIFICATION TO EXPEDIUM SPINE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Story

EXPEDIUM Spine System consists of spinal fixation components designed to accept 6.35mm rods; available in various geometries and sizes. Used by surgeons in clinical settings to stabilize the spine. System provides mechanical support to the vertebral column to facilitate fusion or correction of spinal deformities. Components are implanted during spinal surgery to address conditions like degenerative disc disease, trauma, or scoliosis. System includes manual surgical instruments and cases. Benefit is stabilization of spinal segments to alleviate pain or correct alignment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manufactured from ASTM F-138 implant grade stainless steel and ASTM F-136 or ASTM F-67 implant grade titanium alloy. System components designed for 6.35mm rod compatibility. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring noncervical pedicle or nonpedicle spinal fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous 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

• EXPEDIUM Spine System (K051024)
• EXPEDIUM 5.5mm Commercially Pure Titanium (K052131)
• EXPEDIUM Spine System (K041119)
• EXPEDIUM Spine System cleared as Merlin Spine System (K033901)
• MONARCH Spine System (K021148)
• MONARCH Spine System (K010576)
• MOUTAINEER OCT Spine System (K041203)
• ISOLA Spine System (K944756)

Submission Summary (Full Text)

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#### 510(k) Summary

| SUBMITTER: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 | NOV - 2 2006 |
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- CONTACT PERSON: Marv E. Grav
- DATE PREPARED: July 28, 2006
- CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation, Spinal Intervertebral Body Fixation
- PROPRIETARY NAME: EXPEDIUM Spine System
- PREDICATE DEVICES: EXPEDIUM Spine System (K051024), EXPEDIUM 5.5mm Commercially Pure Titanium (K052131), EXPEDIUM™ Spine System (K041119) and EXPEDIUM™ Spine System cleared as Merlin Spine System (K033901), MONARCH® Spine System (K021148, K010576), and MOUTAINEER™ OCT Spine System (K041203) and ISOLA® Spine System (K944756).
- DEVICE DESCRIPTION: EXPEDIUM Spine System components are designed to accept a 6.35mm rod and are available in various qeometries and sizes.

The EXPEDIUM Spine System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification

- INTENDED USE: The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

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#### MATERIALS: Manufactured from ASTM F-138 implant grade stainless steel and ASTM F-136 or ASTM F-67 implant grade titanium alloy.

## PERFORMANCE DATA:

Performance data were submitted to characterize the EXPEDIUM Spine System components subject of this notification.

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES INC." arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of unity or collaboration. The logo is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Depuy Spine Incorporated c/o Mr. Christopher Klaczyk 325 Paramount Drive Raynham, Massachusetts 02780

NOV - 2 2006

Re: K062174

Trade Name: EXPEDIUM Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNH,MNI, KWO, KWP Dated: October 3, 2006 Received: October 4, 2006

Dear Mr. Klaczyk:

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 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.

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## Page 2 - Mr. Christopher Klaczyk

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" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Fui Hater

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K062174

EXPEDIUM™ Spine System Device Name:

Indications For Use:

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed (doninou do business and radiographic studies); spondylolisthesis; trauma (i.e., fracture or by motory and factory-atures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Prescription Use_ x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorat and Neurological Devices

**510(k) Number** Z000114