MODIFICATION TO XIA 4.5 SPINAL SYSTEM

K060748 · Stryker Spine · NKB · Apr 13, 2006 · Orthopedic

Device Facts

• Record ID: K060748
• Device Name: MODIFICATION TO XIA 4.5 SPINAL SYSTEM
• Applicant: Stryker Spine
• Product Code: NKB · Orthopedic
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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. The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

Device Story

Xia 4.5 Spinal System is a spinal fixation implant system; components include titanium alloy rods, polyaxial/monoaxial bone screws, blockers, hooks, dual staples, and connectors. This line extension adds new dual staple sizes, polyaxial cross connectors, and a rod-to-rod connector allowing linkage between 4.5mm rods and 6.0mm rods from other Stryker systems (Xia, Diapason, Opus). Used by surgeons in clinical settings for posterior or anterolateral spinal stabilization. Implants provide structural support to the spine to facilitate fusion; mechanical properties verified via bench testing to ensure equivalence to predicate systems.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy spinal fixation components (rods, screws, staples, connectors). Non-sterile. Mechanical fixation via polyaxial/monoaxial screws and rod-to-rod connectors. No software or electronic components.

Indications for Use

Indicated for non-cervical spinal 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® 4.5 Spinal System (K050461, K052761, K060361)
• DePuy Spine MOSS Miami™ 4.0 Spinal System (K962628)
• Moss Miami 5.0 Spinal System (K950697)
• CD Legacy 4.5 Spinal System (K020709)

Reference Devices

• Xia® Spinal System (K013688, K984251)
• DIAPASON The Spinal System (K951725)
• OPUS™ Spinal System (K993402, K030369)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification APR 1 3 2006

## Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia® 4.5 Spinal System

## Submission Information

| Name and Address of the Sponsor of the 510(k) Submission: | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Simona Voic<br>Regulatory Affairs Project Manager<br>Stryker Spine<br>2 Pearl Court, Allendale, NJ 07401<br>Tel: (201) 760 - 8145 |
| Date of Summary Preparation: | March 20, 2006 |

**Device Identification**

| Proprietary Name: | Xia® 4.5 Spinal System |
|------------------------------------|------------------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis,<br>21 CFR §888.3050 |
| | Spinal Intervertebral Body Fixation Orthosis<br>21 CFR §888.3060 |
| | Pedicle Screw Spinal System<br>21 CFR §888.3070(b)(1) and (b)(2) |
| Device Product Code: | NKB, KWP, KWQ, MNH, and MNI |

**Predicate Device Information:**

| | K050461, K052761, K060361 - Stryker Spine Xia®<br>4.5 Spinal System |
|--|---------------------------------------------------------------------|
| | K962628 - DePuy Spine MOSS Miami™ 4.0<br>Spinal System |
| | K950697 – Moss Miami 5.0 Spinal System |
| | K020709 - CD Legacy 4.5 Spinal System |

!

.

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## Predicate Device Identification

The Stryker Spine Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks, Dual Staples, and Connectors. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterolateral non-cervical spinal fixation.

#### Description of Device Modification

This submission is intended to address a line extension to Xia " 4.5 Spinal System. The line extension includes:

- 트 A new size dual staple component in both a rostral and a caudal configuration.
- 해 A new polyaxial cross connector in sizes small, medium, large, and extra large, and
- A new longitudinal rod-to-rod connector to join a Ø 4.5 mm rod from the Xia" 4.5 ■ Spinal System to a Ø 6.0 mm rod from the Xia® Spinal System (K013688, K984251), DIAPASON The Spinal System (K951725), and OPUS "M Spinal System (K993402 & K030369).

### Intended Use:

The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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.

The Stryker Spine DIAPASON"™ Spinal System, Opus™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

# Statement of Technological Comparison:

The subject components share the same intended use, material, and basic design concepts as that of the predicate device: Xia® 4.5 Spinal System (K050461, K052761, and K060361). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

Stryker Spine c/o Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, NJ 07401

Re: K060748 Trade/Device Name: Xia® 4.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: March 20, 2006 Received: March 21, 2006

Dear Ms. Voic:

This letter corrects our substantially equivalent letter of April 14, 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 Federal agencies. You must comply with all the Act s requirements, including, but not

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Page 2 - Ms. Simona Voic

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.

This letter will allow you to continue 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/cdrlv/industry/support/index.html.

Sincerely yours,

Hubert Humphrey

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

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# Indications for Use

510(k) Number (if known): \$0667 HK

Device Name: Xia 4.5 Spinal System

Indications For Use:

The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

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

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)

elmdel

vision Sign-Off)

Division of General, Restorative. nd Neurological Devices

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