LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM

K070341 · Ldr Spine USA · KWP · Aug 8, 2007 · Orthopedic

Device Facts

• Record ID: K070341
• Device Name: LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
• Applicant: Ldr Spine USA
• Product Code: KWP · Orthopedic
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Easyspine System is a posterior, noncervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine: 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 Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion

Device Story

Easyspine System is a posterior, noncervical spinal fixation system; provides immobilization and stabilization of spinal segments as an adjunct to fusion. Components include sacral and pedicle screws, rods of varying rigidity, hooks, and cross-connections. Used by surgeons in clinical settings to treat acute/chronic spinal instabilities. Implantation involves specialized instrumentation for distraction, compression, or reduction of thoracic, lumbar, and sacral spine. Implants intended for removal after solid fusion mass development. Benefits include structural support during bone graft healing.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Posterior, noncervical pedicle and non-pedicle spinal fixation system. Components: sacral/pedicle screws, rods, hooks, cross-connections. Mechanical stabilization principle. Intended for surgical implantation.

Indications for Use

Indicated for skeletally mature patients requiring immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• LDR Spine Easyspine System (K043094)
• LDR Spine Easyspine System (K061017)

Submission Summary (Full Text)

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K070341

Image /page/0/Picture/1 description: The image shows the text "LDR spine" in a stylized font. The letters "LDR" are large and bold, with a slightly distressed or textured appearance. Below "LDR", the word "spine" is written in a smaller, simpler font. The overall design is simple and modern.

A Passion for Innovation

AUG - 8 7007

510(k) Summary Easyspine® System

### 1. Owner's Name & Address

LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: [phone] [phone] Fax:

### 2. Contact Person

James Burrows Director of Clinical Marketing LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: [phone] Fax: [phone] Email: [e-mail]

- 3. Date 510(k) Summary Prepared: July 12, 2007

| 4. | Trade Name: | LDR Spine Easyspine® System |
|----|-----------------|-----------------------------------------------------------------------|
| | Common Name: | Posterior Thoracolumbar Spinal System |
| | Classification: | KWP: Spinal Interlaminal Fixation Orthosis -<br>Class II per 888.3050 |
| | | MNI and MNH: Pedicle Screw Spinal System -<br>Class II per 888.3070 |
| | | NKB: Pedicle Screw Spinal System - Class III<br>per 888.3070 |

- 5. Legally Marketed Equivalent Predicate Devices: LDR Spine Easyspine System (K043094 and K061017)

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#### 6. Device Description

The Easyspine System is designed to aid in the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.

Easyspine® consists of sacral and pedicle screws, cross-connections, rods of different rigidities and hooks. Specialized associated instrumentation is designed for implantation of these devices and for the distraction, compression or reduction of the lumbar and thoracic spine.

#### 7. Intended Use of the Device

The Easyspine System is a posterior, noncervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine:

- . 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
- Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis) .
- . Tumor
- . Pseudoarthrosis
- Failed previous fusion

#### 8. Non-Clinical Performance Data

Mechanical test results demonstrate that the proposed Easyspine System is substantially equivalent to the predicate device.

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15076341

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG - 8 2007

LDR Spine USA % Mr. James Burrows Director of Clinical Marketing 4030 West Braker Lane, Suite 360 Austin, Texas 78759

> K070341 Trade/Device Name: Easyspine® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNI, MNH Dated: July 12, 2007 Received: July 13, 2007

Dear Mr. Burrows:

Re:

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. James Burrows

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 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 vours.

Barbara Buchner

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

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510(k) Number (if known): K070341

Device Name: LDR Spine Easyspine® System

Indications for Use:

The Easyspine System is a posterior, noncervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine:

- 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 ●
- Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Carbare for
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K070841