EASYSPINE SYSTEM

K043094 · Ldr Spine USA · MNI · Feb 11, 2005 · Orthopedic

Device Facts

• Record ID: K043094
• Device Name: EASYSPINE SYSTEM
• Applicant: Ldr Spine USA
• Product Code: MNI · Orthopedic
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LDR 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.

Device Story

Easyspine System is a posterior lumbar pedicle screw/rod spinal system used by surgeons to provide temporary stabilization during spinal fusion. Components include polyaxial screws, rods, and crosslinks. Side-loading polyaxial screws allow posterior-lateral rod insertion; standard screws provide 20-degree angulation; dual-polyaxial alpha-screws provide 25-degree angulation. Rods feature a machined flat surface to provide variable stiffness while maintaining strength. System is used in clinical/OR settings by trained spinal surgeons. Output is a rigid construct that immobilizes spinal segments, facilitating fusion and potentially reducing patient pain and instability associated with spinal deformities or trauma.

Clinical Evidence

Bench testing only. Fatigue and static testing were performed according to accepted engineering and scientific principles to demonstrate mechanical equivalence to the predicate device.

Technological Characteristics

Posterior pedicle screw/rod system. Materials: Titanium alloy. Components: Side-loading polyaxial screws, dual-polyaxial alpha-screws, 6.0mm diameter rods with machined flat surfaces for variable stiffness, and crosslinks. Connectivity: None. Sterilization: Implants supplied sterile; instruments supplied non-sterile.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for acute/chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including 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

• Orthopedic Alliance Spine System (K033826)

Submission Summary (Full Text)

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# -EB 1 1 2005

K0413094/

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>-10(k) >><br>TIMMATIC<br>nformanon | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Premarket Notification.<br>ection 510(k) | DATEC |
| State Station Company of Children Company of<br><br><br>1 | ANTIADVIX<br>2005 |

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

- 1. Establishment Name
તર

Contact Person:

Mr. Brian Burkinshaw Director, Innovation & Technology Solutions Telephone: [phone] Fax: [phone]

#### 2. Device Name:

Name:

Trade Name: Easyspine System Common Name(s): Posterior lumbar spine system

Suite 360

LDR Spine USA

4030 West Braker Lane

Austin, TX. 78759

Classification Pedicle Screw Spinal System Name(s):

- 4. Equivalent Predicate Device:
Orthopedic Alliance Spine System, K033826, Orthopedic Alliance, LLC.

#### ર્ડ Classification(s):

\$ 888.3070 - Pedicle Screw Spinal System (Class II Uses)

(a) Identification. Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 22Cr-13Ni-SMan stainless steel, Ti-6Al-4V, and unalloyed titanium that allow the surgeon to build an implant system to fit the putient's anatomical and physiological requirements. Such a spinal implant of an including of anchors (e.g., bolts, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bols; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

(b) Classification. (1) Class II (special controls), when intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute ad chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic innaiment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthronipul 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 spiral conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability of deformity of the thoracic, lumbar, and saval spins secondary to severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra, degenerative spondoloisthesis

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with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spiral 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."

| Device Class: | Class II for the requested indications |
|-----------------------|----------------------------------------------|
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Product Code(s): | MNI, MNH |

### રું. Device Description:

The LDR Easyspine® System consists of various screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the thoraco-lumbar spine.

This system includes side-loading polyaxial screws, which allow the surgeon to easily insert the spinal rod using a posterior-lateral loading technique into the fixation components.

The rod opening of the screw heads can be positioned medially or laterally. The polyaxial locking mechanism of the standard screws allows a 20 degree angulation in all directions.

The dual-polyaxial α-screw (alpha screw) provides an additional 5 degrees of angulation to facilitate loading of the rod, even when the difference in pedicular screw angulation is significant relative to the next screw.

Crosslinks (transverse connectors) are provided to increase rotational stiffness of a given construct as desired by the clinician.

Rods consist of a single diameter (6.0mm) yet offer variable stiffness. Multiple lengths of spinal rods are included with this system as is typical for essentially all competitive systems. The variable stiffness/rigidity of the various rod offerings is accomplished by fabricating the rods with a machined flat surface on the rod, from one end to the other, following the longitudinal axis of each rod. Thus, the cross section of the rods (as measured at the flattened area), provide comparable strength and stiffness to other rods available in approved systems.

## Materials:

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| rannim<br>110V | A CTT / T 1 9 /<br>00 | TOO COSS<br>1 1 14 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------- | COLORIO COLLECT<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------<br>CARAGE |

Testing Summary: Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to porform in a manner equivalent to the comparison device.

#### Summary Comparison Table: 6.

Feature Comparison Table:

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| FEATURE | Easyspine System | Orthopedic Alliance Spine System | SE? |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indications for<br>Use: | degenerative spondylolisthesis with objective<br>evidence of neurologic impairment, fracture,<br>dislocation, scoliosis, kyphosis, spinal tumor, failed<br>previous fusion (pseudarthrosis) | degenerative spondylolisthesis with objective<br>evidence of neurologic impairment, fracture,<br>dislocation, scoliosis, kyphosis, spinal tumor, failed<br>previous fusion (pseudarthrosis) | YES |
| Design: | Posterior - pedicle screw/rod spine system | Posterior - pedicle screw/rod spine system | YES |
| Sterile: | Implants supplied sterile<br>Instruments supplied nonsterile | Both supplied nonsterile | YES |
| Rod Diameter: | 6mm | 4mm | NO/YES |
| Material: | Titanium Alloy | CP titanium & titanium alloy | YES |
| Screw Sizes: | 6 & 7mm | 5, 6 & 7mm | YES |
| Manufacturer: | LDR Spine USA | Orthopedic Alliance, LLC | YES |
| Product Code: | MNI, MNH | MNI | YES |

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FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Burkinshaw Director Technology Solutions LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, Texas 78759

Re: K043094

Trade/Device Name: Easyspine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: January 31, 2005 Received: February 2, 2005

Dear Mr. Burkinshaw:

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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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 prematicate 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,

Sincerely yours,

Mark N. Millan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Add to File: 510(k) No: K043094

Jan. 18, 2005

Page 1 of 1

510(k) Number: K043094

Easyspine System Device Name(s):

Indications For Use:

The LDR 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 _____________________________________________________________________________________________________________________________________________________________

OR

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)

(Per 21 CFR 801.109) 1-2-96)

(Optional format

Mal. A. Milliken

SANTALIVE, કારણ

510(k) Notification

K043094

(Substitute - New page) 12