LANX INTERVERTEBRAL BODY FUSION DEVICE

K073144 · Lanx, LLC · MAX · Jan 24, 2008 · Orthopedic

Device Facts

• Record ID: K073144
• Device Name: LANX INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Lanx, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jan 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System,

Device Story

The Lanx Intervertebral Body Fusion Device is a spinal implant designed to facilitate intervertebral body fusion. The device is constructed from PEEK-OPTIMA and features a hollow center to hold autogenous bone graft and transverse grooves to enhance stability. It is implanted by a surgeon via anterior or posterior approaches and must be used in conjunction with supplemental spinal fixation systems. The device is available in various sizes to accommodate patient-specific anatomy. By providing structural support and a space for bone graft, the device promotes fusion at the affected spinal levels, potentially alleviating discogenic back pain in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Performance testing was conducted in accordance with ASTM F2077-03 and ASTM F2267-04. The device met all acceptance criteria.

Technological Characteristics

Material: PEEK-OPTIMA. Design: Hollow center for bone graft, transverse grooves for fixation. Form factor: Various sizes for anatomical variation. Sterilization: Provided non-sterile. Standards: ASTM F2077-03, ASTM F2267-04.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD defined as discogenic back pain with radiographic confirmation. Patients must have failed six months of non-operative treatment. May include patients with prior non-fusion surgery at the level(s) or up to Grade 1 spondylolisthesis or retrolisthesis.

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

• Zimmer Spine, Inc. BAK™ Vista Interbody Fusion System
• DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine System
• Lanx, LLC, Lanx Vertebral Body Replacement Device

Submission Summary (Full Text)

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## 510(k) SUMMARY

# Lanx, LLC's Intervertebral Body Fusion Device

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Lanx, LLC 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021

Contact Person: Greg Causey Phone: [phone] Facsimile: 303-443-7501

Date Prepared: November 4, 2007

JAN 2 4 2003

# Name of Device and Name/Address of Sponsor

Lanx Intervertebral Body Fusion Device

Lanx, LLC 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021

## Common or Usual Name

Intervertebral Body Fusion Device

### Classification Name

.

Orthosis, spinal intervertebral fusion

# Predicate Devices

Zimmer Spine, Inc. BAK™ Vista Interbody Fusion System DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine System Lanx, LLC, Lanx Vertebral Body Replacement Device

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#### Intended Use / Indications for Use

The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System,

### Technological Characteristics

The Lanx Fusion System is made of PEEK-OPTIMA® The Fusion System has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. It is available in a variety of different sizes accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

## Performance Data

Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04. In all instances, the Lanx Fusion System met acceptance criteria and functioned as intended.

## Substantial Equivalence

The Lanx Fusion System is as safe and effective as the previously cleared Lanx Vertebral Body Replacement Device and the previously approved, and now reclassified, Zimmer Spine, Inc. BAKTM Vista Interbody Fusion System and the DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine System (the "Predicate Devices").

The Lanx Fusion System has the same intended use/indications, and similar technological characteristics and principles of operation as its predicate devices. The minor technological differences between the Lanx Fusion System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Lanx Fusion System is as safe and effective as the predicate devices. Thus, the Lanx Fusion System is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2008

Lanx, LLC % Mr. Greg Causey 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021

Re: K073144

Trade/Device Name: Lanx Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: November 6, 2007 Received: November 7, 2007

Dear Mr. Causey:

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. Greg Causey

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Millison

Mark N. Melkerson 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 Statement

510(k) Number (if known): K073144

# Device Name: Lanx Intervertebral Body Fusion Device

Indications for Use:

The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplimental fixation systems include the Lanx Spinal Fixation System.

| Prescription Use_X | AND/OR | Over-The-Counter Use_ |
|--------------------------------|--------|---------------------------|
| (Part 21 C.F.R. 801 Subpart D) | | (21 C.F.R. 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark A. Millham

(Division of General, Restorative, and Non-ologica

K073144

510(h) Number