XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM

K061854 · Stryker Spine · NKB · Jul 27, 2006 · Orthopedic

Device Facts

• Record ID: K061854
• Device Name: XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: NKB · Orthopedic
• Decision Date: Jul 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xia Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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. The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUSTM Spinal System arc intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

Device Story

Line extension to Xia Titanium and Stainless Steel Spinal Systems; introduces long arm bone screws and long arm hooks. System components provide anterior/anterolateral and posterior spinal fixation. Used by surgeons in clinical/OR settings to stabilize spinal segments. Components integrate with existing Xia system hardware to address spinal pathologies including DDD, trauma, and deformities. Benefits include enhanced surgical flexibility and fixation stability for spinal fusion procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Spinal fixation system consisting of long arm bone screws and hooks. Materials are titanium and stainless steel. System is designed for noncervical pedicle and non-pedicle fixation. Components are compatible with existing Xia system hardware, DIAPASON™ rods, and OPUS™ rods.

Indications for Use

Indicated for noncervical pedicle and non-pedicle fixation in patients with 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

• Stryker Spine Xia® Titanium Spine System (K060361, K013823, K002858, K022160)
• Stryker Spine Xia® Stainless Steel Spine System (K060361, K031090, K012870)

Reference Devices

• DIAPASON™ Spinal System
• OPUS™ Spinal System

Submission Summary (Full Text)

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Line Extension to the Xia Titanium Spinal System and Stainless Steel Spinal System

Special 510(k) Premarket Notification

### Special 510(k) Summary of Safety and Effectiveness Line Extension to the Xia® Titanium Spinal System and Xia® Stainless Steel Spinal System

Proprietary Name:

Xia® Titanium Spinal System and Xia® Stainless Steel Spinal System

Common Name:

Spinal Fixation Appliances

JUL 2 7 2006

Proposed Regulatory Class:

Class III

Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050 Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060 Pedicle Screw Spinal System 21 CFR 888.3070(b)(1) and (b)(2)

Device Product Code:

For Information contact:

Date Summary Prepared:

Predicate Devices

・・・

NKB, MNH, MNI, KWP, KWQ

Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, NJ 07401 Telephone: [phone] Fax: [phone] Email: Simona. [e-mail]

June 29, 2006

l

Stryker Spine Xia® Titanium Spine System K060361, K013823, K002858, K022160.

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Extension to the Xia® Titanium Spinal System and a Stainless Steel Spinal System

Special 510(k) Premarket Notification K061854 Pg 20F3

Stryker Spine Xia® Stainless Steel Spine System K060361, K031090, K012870.

existing Xia Titanium Spinal System and

arm bone screws and hooks.

This 510(k) is intended to introduce an extension to the

Xia Stainless Steel Spinal System that includes long

Description of Device Modification

Intended Use

Summary of the Technological Characteristics

The Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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.

The 6 mm diameter rods from the DIAPASON™ Spinal System and OPUSTM Spinal System arc intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

Documentation is provided which demonstrates the new long arm bone screws and long arm hooks of the Stryker Spine Xia® Titanium Spinal System and Xia® Stainless Steel Spinal System to be substantially

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Special 510(k) Premarket Notifi,

# KO61854 M30F3

equivalent to its predicate devices in terms of its material, design, and indications for use. Engineering analysis to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal Xia® Titanium Spinal System and Xia® Stainless Steel Spinal System Long Arm Bone Screws and Long Arm Hooks.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of a human figure. The figure is composed of three lines that form the shape of a person's head and shoulders.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 202012

Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K061854

Trade/Device Name: Xia® Titanium Spinal System & Xia® Stainless Steel Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: June 29, 2006 Received: June 30, 2006

Dear Ms. Voic:

This letter corrects our substantially equivalent letter of July 27, 2006.

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 (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 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

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Page 2 - Ms. Simona Voic

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K061854

Device Name: Line Extension to the Xia Titanium Spinal System and Xia Stainless Steel Spinal System

Indications for Use:

The Xia Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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.

The 6 mm diameter rods from the DIAPASONT™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Herbert Lemmer

Division of General, Restorative, and Neurological Devices

510(k) Number_