EASYSPINE SYSTEM

K061017 · Ldr Spine USA · MNI · Aug 10, 2006 · Orthopedic

Device Facts

• Record ID: K061017
• Device Name: EASYSPINE SYSTEM
• Applicant: Ldr Spine USA
• Product Code: MNI · Orthopedic
• Decision Date: Aug 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LDR Spine USA Easyspine System is a posterior, non-cervical, 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 or deformities of the thoracic, lumbar, and sacral spine: spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis (with objective evidence of neurologic impairment), trauma (i. e., fracture or dislocation), spinal stenosis, deformities or curvatures (i. e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Easyspine System is a posterior, non-cervical, pedicle screw-based spinal stabilization system. Components include sacral and pedicle screws, rods, and cross-connectors. Designed for mono- and multi-segmental stabilization to promote fusion in the thoracic, lumbar, and sacral spine. Features lateral offset loading, allowing separate rod tightening and polyaxiality locking; facilitates spondylolisthesis reduction by enabling bone screwing after rod tightening. Used by surgeons in clinical settings to support the healing process following spinal surgery. Implants are single-use, titanium alloy (Ti6Al4V); instruments are medical-grade stainless steel. System provides temporary stabilization; not intended to replace normal body structures or withstand loading in cases of incomplete healing.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ASTM 1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. No clinical data presented.

Technological Characteristics

Posterior pedicle screw/rod system. Materials: Titanium alloy Ti6Al4V (ASTM F-136-92) for implants; medical grade stainless steel for instruments. Screw diameters: 6 mm and 7 mm. Rod diameter: 6 mm. Sterilization: Gamma radiation for implants (sterile); instruments non-sterile. Shelf life: 5 years. Connectivity: None (mechanical).

Indications for Use

Indicated for skeletally mature patients requiring immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. Conditions include spondylolisthesis (grades 3-4 at L5-S1 or degenerative with neurologic impairment), trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and 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

• Easyspine System (K043094)

Submission Summary (Full Text)

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

K061017 (pg 1 x 3)

Image /page/0/Picture/1 description: The image shows the logo for LDR Spine. The letters "LDR" are stacked on top of the word "spine". The font is bold and sans-serif.

A Passion for Innovation

AUG 1 0 2006

# 510(k) Summary LDR Spine USA Easyspine® System

## Lateral Polyaxial (LP) and LP Multiaxial Pedicle Screws 6 mm and 7 mm Diameters

#### Owner's Name & Address 1.

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

Phone: [phone] [phone] Fax:

#### 2. Contact Person

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

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

#### Date 510(k) Summary Prepared: April 12, 2006 3.

- Easyspine® System 4. Trade Name: Pedicle Screw Spinal System Common Name: Pedicle Screw Spinal System (21 CFR §888.3070, Classification Name: Product Codes MNI and MNH)
### Legally Marketed Equivalent Predicate Device 5. K043094 - LDR Spine USA Easyspine System consisting of rods, connectors, and Standard and a pedicle screws.

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

K06i017 (pg 2 of 3)

#### 6. Device Description

Easyspine implants are single use devices for mono-and multi-segmental stabilization of the lumbar and thoracic vertebrae to promote fusion. The Easyspine System consists of sacral and pedicle screws, cross-connections, and rods of different rigidities. Specialized associated instrumentation is designed for implantation of these devices and for the distraction, compression or reduction of the lumbar and thoracic spine.

The implants are made of surgical titanium alloy Ti6AI4V (ASTM F-136-92). Instruments used to implant Easyspine® are made of medical grade stainless steel.

Both the Easyspine LP and Easyspine LP Multiaxial designs consist of various screws, rods, and connectors which are intended to provide temporary stabilization following surgery to fuse the thoraco-lumbar spine. The systems include side-loading screws which are offset as compared to the standard configuration. This offset allows separate rod tightening and polyaxiality locking. Additionally, the system facilitates conducting spondylolisthesis reduction by allowing bone screwing after rod tightening.

The lateral offset loading feature incorporated into the designs has not altered the fundamental technology of the predicate Easyspine pedicle screw system.

Operatively inserted implants serve to support the normal healing process. They are not intended to replace normal body structures, nor in cases of incomplete healing, to withstand the continually applied loading conditions.

#### 7. Intended Use of the Device

The LDR Spine USA Easyspine System is a posterior, non-cervical, 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 or deformities of the thoracic, lumbar, and sacral spine: spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis (with objective evidence of neurologic impairment), trauma (i. e., fracture or dislocation), spinal stenosis, deformities or curvatures (i. e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

Kcl017 (pg 3 of 3)

### Summary of Technological Characteristics 8.

| Feature | Easyspine System w/ Ø6.0 mm, Ø7 mm LP & LP Multiaxial<br>Screw | Easyspine<br>System<br>(K043094) | Substantially<br>Equivalent? |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------|
| Indications for<br>Use: | The LDR Easyspine® System is a posterior, non-cervical, pedicle system<br>intended to provide immobilization and stabilization of spinal segments in<br>skeletally mature patients as an adjunct to fusion in the treatment of the<br>following acute and chronic instabilities or deformities of the thoracic,<br>lumbar, and sacral spine: spondylolisthesis (grades 3 and 4) of the L5-S1<br>vertebra, degenerative spondylolisthesis (with objective evidence of<br>neurologic impairment), trauma (i. e., fracture or dislocation), spinal<br>stenosis, deformities or curvatures (i. e., scoliosis, kyphosis, and/or<br>lordosis), tumor, pseudoarthrosis, and failed previous fusion. | Same | YES |
| Design: | Posterior - pedicle screw/rod spine system | Same | YES |
| Sterile: | Implants supplied sterile<br>Instruments supplied non-sterile | Same | YES |
| Implant<br>Sterilization<br>Methods: | Gamma radiation | Same | YES |
| Implant Shelf<br>Life: | Five Years | Same | YES |
| Rod Diameter: | 6 mm | Same | YES |
| Material: | Titanium Alloy Ti6Al4V | Same | YES |
| Screw Sizes: | 6 and 7 mm Diameters | Same | YES |
| Manufacturer: | LDR Spine Medical | Same | YES |
| Product Code: | MNI, MNH | Same | YES |

#### Non-Clinical Performance Data 9.

Testing was conducted in accordance with ASTM 1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Based upon the test data presented, risk analysis, and comparison of features, the LDR Spine 6 mm and 7 mm diameter Easyspine LP and LP Multiaxial screws are substantially equivalent to the LDR Spine 6mm and 7 mm diameter Easyspine Standard and Easyspine a pedicle screws that were cleared in premarket notification K043094.

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

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing the department's mission to protect and promote the health and well-being of Americans. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and recognizable, representing the HHS's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2006

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

Re: K061017 Trade Name: Easyspine® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: July 19, 2006 Received: July 20, 2006

Dear Mr. Burrows:

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.

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

Page 2 - Mr. James W. 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 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbery Buchum

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

Enclosure

{5}------------------------------------------------

## Indications for Use

KO61017 510(k) Number:

Easyspine® System Device Name(s):

### Indications for Use:

The LDR Spine USA Easyspine System is a posterior, noncervical, 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 or deformities of the thoracic, lumbar, and sacral spine: spondylolisthesis (grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use _ X

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Barbara Hutchins for MKM
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K061012

(Per 21 CFR 801.109)

(Optional format 1-2-96)