AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX

K100865 · Stryker Spine · MAX · Aug 11, 2010 · Orthopedic

Device Facts

• Record ID: K100865
• Device Name: AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
• Applicant: Stryker Spine
• Product Code: MAX · Orthopedic
• Decision Date: Aug 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The AVS® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach. The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

Device Story

Intervertebral body fusion device; PEEK spacer; hollow design with serrated surfaces for fixation; embedded Tantalum radiopaque markers for radiographic visualization. Implanted via posterior or posterolateral approach by surgeons; used with autogenous bone graft and supplemental fixation systems. Provides structural support to vertebral column to facilitate fusion in patients with degenerative disc disease. Benefits include stabilization of spinal segment and promotion of arthrodesis.

Clinical Evidence

Bench testing only. Mechanical testing included static compression, dynamic compression, static compression shear, and dynamic compression shear to demonstrate substantial equivalence.

Technological Characteristics

PEEK (Polyetheretherketone) interbody spacer; Tantalum radiopaque markers; serrated surface geometry; various lengths, heights, and lordotic angles. Mechanical testing performed per FDA Class II Special Controls Guidance.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including up to Grade I spondylolisthesis, who have failed six months of nonoperative therapy. Must be used with autogenous bone graft and supplemental fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Lumbar I/F Cage® with VSP® Spine System (P960025)
• Stryker Spine AVS® TL PEEK Spacers (K083661)
• Stryker Spine AVS® PL PEEK Spacers (K093704)
• K090816
• K082014
• K080758
• K073470
• LifeSpine Plateau Spacer (K080411)

Submission Summary (Full Text)

{0}------------------------------------------------

K100865 page 1 of 2

Stryker Spine AVS® Navigator PEEK Spacer's

## 510(k) Summary: AVS® Navigator PEEK Spacers AUG11 2010

| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Kimberly Lane<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | June 10, 2010 |
| Trade Name | Stryker Spine AVS® Navigator PEEK Spacers |
| Proposed Class | Class II |
| Classification Name and Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | MAX |
| Predicate Devices | The AVS® Navigator PEEK Spacer was shown to be<br>substantially equivalent to the devices listed below:<br>• DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine System, PMA# P960025,<br>• Stryker Spine AVS® TL PEEK Spacers, 510(k) # K083661,<br>• Stryker Spine AVS® PL PEEK Spacers, 510(k) #s K093704,<br>• K090816, K082014, K080758 and K073470,<br>• LifeSpine Plateau Spacer, 510(k) #K080411. |
| Device Description | The AVS® Navigator PEEK Spacer is intended for use as an interbody fusion device. It is offered in a variety of lengths, heights and lordotic angles. The hollow implant has serrations on the top and bottom for fixation. Three (3) Tantalum Radiopaque markers have been embedded within the implant to help allow for visualization in radiographic images. |
| Intended Use | The Stryker Spine AVS® Navigator PEEK Spacers are<br>intervertebral body fusion devices indicated for use with<br>autogenous bone graft in patients with degenerative disc disease<br>(DDD) at one level or two contiguous levels from L2 to S1.<br><br>DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies. The DDD patients may also have up to Grade I<br>spondylolisthesis at the involved level(s). These patients should<br>be skeletally mature and have six months of nonoperative<br>therapy.<br><br>The AVS® Navigator PEEK Spacers are to be implanted via a<br>posterior or posterolateral approach.<br><br>The AVS® Navigator PEEK Spacers are intended to be used with<br>supplemental fixation systems that have been cleared for use in<br>the lumbosacral spine. |
| Summary of the<br>Technological<br>Characteristics | Testing in compliance with FDA's June 12, 2007 "Class II<br>Special Controls Guidance Document: Intervertebral Body<br>Fusion Device" was performed for the AVS® Navigator PEEK<br>Spacers and demonstrated substantial equivalent performance<br>characteristics to the identified predicate device systems. The<br>following mechanical tests were performed:<br>• Static Compression<br>• Dynamic Compression<br>• Static Compression Shear<br>• Dynamic Compression Shear |

{1}------------------------------------------------

Stryker Spine AVS® Navigator PEEK Spacers

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

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

AUG 1 1 2010

Stryker Spine % Ms. Kimberly Lane Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K100865

Trade/Device Name: Stryker Spine AVS® Navigator PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 04, 2010 Received: August 05, 2010

Dear Ms. Lane:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

{3}------------------------------------------------

Page 2 - Ms. Kimberly Lane

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); 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.

Barbara buchner

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

Enclosure

{4}------------------------------------------------

Stryker Spine AVS® Navigator PEEK Spacers

## Indications for Use AUG 1 1 2010

510(k) Number (if known): K_IOO Block 5

Device Name: Stryker Spine A VS® Navigator PEEK Spacers

Indications For Use:

The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® Navigator PEEK Spacers are to be implanted via a posterior or posterolateral approach. ·

The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

Prescription Use x 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)

Signature

Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIDDS65 510(k) Number_