LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

K091088 · Ldr Spine USA · ODP · Jul 14, 2009 · Orthopedic

Device Facts

• Record ID: K091088
• Device Name: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Applicant: Ldr Spine USA
• Product Code: ODP · Orthopedic
• Decision Date: Jul 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine Cervical Interbody Fusion System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system. When used as a vertebral body replacement device, the ROI-C and MC+ implants are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

Device Story

D-shaped interbody fusion/vertebral body replacement implants; ROI-C (PEEK OPTIMA LT1) and MC+ (material unspecified) designs; feature enclosed/open graft spaces and lateral teeth for bone engagement. ROI-C utilizes optional titanium alloy (TiAl6V4) anchoring plates; MC+ utilizes anchoring clips for supplemental internal fixation. Implants inserted via open, anterior approach by surgeons. Devices provide structural support for fusion or vertebral replacement; require supplemental internal fixation. Benefits include stabilization of spinal segments or replacement of resected vertebral bodies to facilitate healing.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F2077 and ASTM F2267 to demonstrate substantial equivalence.

Technological Characteristics

D-shaped implants; ROI-C made of PEEK OPTIMA LT1; ROI-C anchoring plates made of titanium alloy (TiAl6V4). Features lateral teeth for bone engagement. Mechanical testing per ASTM F2077 and ASTM F2267. Requires supplemental internal fixation.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) with radicular symptoms at one level (C2-T1) after 6 weeks of failed non-operative treatment; also indicated for partial vertebral body replacement in the thoracolumbar spine (T1-L5) following resection due to tumor or trauma/fracture.

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

• BAK/C (P980048)
• Affinity Cage System (P000028)
• ROI-C VBR (K083857)
• MC+ Partial VBR (K043479)

Submission Summary (Full Text)

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# LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices)

# 510(k) Summary of Safety and Effectiveness

JUL 1 4,2009

| SUBMITTED BY | LDR Spine USA<br>4030 W. Braker Lane, Suite 360<br>Austin, TX 78759 |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FOREIGN ESTABLISHMENT<br>REGISTRATION NUMBER | 3004788213 |
| US AGENT ESTABLISHMENT<br>REGISTRATION NUMBER | 3004903783 |
| CONTACT PERSON | Noah Bartsch<br>Manager, Clinical, Regulatory and Quality Affairs<br>Phone: [phone]<br>Fax: [phone] |
| SUBMISSION PREPARED BY | Lisa Peterson<br>QA Consulting, Inc.<br>Phone: [phone] |
| DATE PREPARED | July 13, 2009 |
| CLASSIFICATION NAME | ODP 888.3080 - Intervertebral Fusion Device with<br>Bone Graft, Cervical |
| COMMON NAME | Intervertebral Body Fusion Device (ODP)<br>Spinal Vertebral Body Replacement Device (MQP) |
| PROPRIETARY NAME | LDR Spine Cervical Interbody Fusion System |
| PREDICATE DEVICE(S) | Predicate devices include several recently down<br>classified cages, as well as cleared VBR systems:<br>- BAK/C (P980048, Zimmer Spine, Approved<br>4/20/01)<br>- Affinity Cage System (P000028, Medtronic,<br>Approved 6/13/02)<br>- ROI-C VBR (K083857, LDR Spine, Cleared<br>2/12/09)<br>- MC+ Partial VBR (K043479, LDR Spine,<br>Cleared 6/30/05) |

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## SUBSTANTIAL EQUIVALENCE

The LDR Spine Cervical Interbody Fusion System was determined to be substantially equivalent to several commercially available systems.

### DEVICE DESCRIPTION

## ROI-C

ROI-C consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors.

The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed (and optional) supplemental fixation - the ROI-C Anchoring Plate. The Anchoring Plate, made of titanium alloy (TiAl6V4) can be inserted to obtain fixation to the vertebral bone, by locking in place to the PEEK implant via Locking Tabs.

#### MC+

MC+ consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an open or enclosed graft space design. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the Anchoring Clip.

MC+ is intended to be used with supplemental internal fixation (i.e. anchoring clips). MC+ is designed for use with one Anchor Clip. The mechanism by which the Anchoring Clip locks into the MC+ device is achieved via the mating slot in the anterior face and the anti-backout tabs of the Anchoring Clip itself.

#### INDICATIONS:

When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine Cervical Interbody Fusion System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

When used as a vertebral body replacement device, the ROI-C and MC+ implants are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

Page 2 of 3

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## MECHANICAL TEST DATA

Mechanical test results demonstrate that the proposed LDR Spine Cervical Interbody Fusion System is substantially equivalent to the predicate device. Testing was performed in accordance with ASTM F2077 and ASTM F2267.

.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUL 1 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LDR Spine USA % Mr. Noah Bartsch, M.S., R.A.C. Manager, Clinical, Regulatory & Quality Affairs 4030 W. Braker Lane, Suite 360 Austin, TX 78759

Re: K091088

Trade/Device Name: LDR Spine Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MQP Dated: April 12, 2009 Received: April 15, 2009

Dear Mr. Bartsch:

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 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); 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.

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## Page 2 - Mr. Noah Bartsch, M.S., R.A.C.

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/CDRH0ffices/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 yours,

Charlyne Vuchnich

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):

Device Name:

LDR Spine Cervical Interbody Fusion System

Indications for Use:

When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine Cervical Interbody Fusion System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

When used as a vertebral body replacement device, the ROI-C and MC+ implants are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(EXT for MXM

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

1088 510(k) Number_K09