MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE

K121323 · Medicrea International · KWQ · Jul 18, 2012 · Orthopedic

Device Facts

• Record ID: K121323
• Device Name: MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
• Applicant: Medicrea International
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is designed to be used at L5/S1 level. It is intended for use as anteriorly placed supplemental fixation device via the anterior surgical approach below the great vessel bifurcation. The device is intended as a temporary fixation device until fusion is achieved. MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is intended for anterior lumbar spine at L5/S1 level, for the following indications: 1. Degenerative Disc Disease (DDD) at L5/S1 level. (DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) 2. Pseudoarthrosis 3. Spondylolysis 4. Trauma (i.e., fracture or dislocation) 5. Spinal stenosis 6. Deformities and or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) 7. Tumor 8. Failed previous fusion. MEDICREA® INTERNATIONAL anterior lumbo-sacral plate is intended to be used with autograft and or allograft as an adjunct to fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage and a lumbo-sacral plate for degenerative conditions.

Device Story

Anterior lumbo-sacral plate system; provides supplemental fixation to lumbar spine at L5/S1 level; used as adjunct to fusion with autograft/allograft. Implant consists of triangular plate and 3-4 titanium alloy screws; screws secured via PEEK OPTIMA® insert. Used in anterior surgical approach below great vessel bifurcation. Provides mechanical stability to facilitate spinal fusion; temporary fixation until fusion achieved. Operated by surgeons in clinical/OR setting. Benefits patient by providing structural support to spinal column during healing process.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Titanium alloy (ASTM F136, ISO 5832-3) and PEEK OPTIMA® LT1 (ASTM F2026). Design: Triangular plate with 3-4 screws. Security: Screws clipped within PEEK insert. Energy source: None (mechanical). Connectivity: None.

Indications for Use

Indicated for patients requiring anterior lumbar spinal stabilization at L5/S1 level for degenerative disc disease, pseudoarthrosis, spondylolysis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, or failed previous fusion. Requires use with autograft/allograft. Patients with degenerative conditions must have failed 6 months of non-operative treatment.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Alphatec Spine Anterior Lumbar Plating System (K101255)
• Spinal USA Anterior Lumbar Plate System (K091044)
• Pyramid® +4 Anterior Lumbar Plate System (K080429)

Submission Summary (Full Text)

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K121323

# JUI 18 2012

### 510(k) Summary for the MEDICREA® INTERNATIONAL anterior lumbo-sacral plate

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the lumbo-sacral plate.

### Date Prepared: 25/04/2012

Common Name:

- 1. Submitter:
# Contact Person:

| MEDICREA INTERNATIONAL | Laure AVIRON-VIOLET | MEDICREA INTERNATIONAL |
|------------------------|-----------------------------|------------------------|
| 14 Porte du Grand Lyon | | 14 Porte du Grand Lyon |
| NEYRON 01700 | | NEYRON 01700 |
| FR | | FR |
| Trade name: | Anterior Lumbo-Sacral Plate | |

2.

Lumbar Stabilization Device

Classification Name: Spinal intervertebral body fixation orthosis

Classification and Regulation: KWQ-888.3060- Appliance, Fixation, Spinal Intervertebral Body,

### 3. Predicate or legally marketed devices which are substantially equivalent:

- . The Alphatec Spine Anterior Lumbar Plating System, (Alphatec Spine, K101255)
- The Spinal USA Anterior Lumbar Plate System (Spinal USA, K091044) .
- . The Pyramid® +4 Anterior Lumbar Plate System (MEDTRONIC, K080429)

### Description of the device: বা

The MEDICREA® Anterior Lumbo sacral Plate system is a stabilization device for use as an adjunct to fusion. The implant is composed of :

- one lumbo sacral plate
- either 3 or 4 anterior lumbar screws , depending on the lumbosacral plate considered in the range

The anterior lumbar screw is manufactured from titanium alloy meeting ASTM F136 and ISO 5832-3 standards, and the lumbosacral plate is manufactured from titanium alloy meeting ASTM F136 and ISO 5832-3 and PEEK OPTIMA® meeting the ASTM F 2026.

## Materials: Titanium alloy and PEEK OPTIMA® LT1

Function: The Anterior Lumbosacral Plate was developed as an implant:

- to supplement an interbody device with an anterior fixation .
- . provide anterior stabilization to the lumbar spine
- to augment the development of a solid spinal fusion .
- . to provide stability to ease fusion
- . to be mechanically resistant to allow the fusion of the operated level

Ps 1 of 4/

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K121323

### 5. Intended Use

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is designed to be used at L5/S1 level. It is intended for use as anteriorly placed supplemental fixation device via the anterior surgical approach below the great vessel bifurcation. The device is intended as a temporary fixation device until fusion is achieved.

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is intended for anterior lumbar spine at L5/S1 level, for the following indications:

1. Degenerative Disc Disease (DDD) at L5/S1 level. (DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies)

- 2. Pseudoarthrosis
- 3. Spondylolysis
- 4. Trauma (i.e., fracture or dislocation)
- 5. Spinal stenosis
- 6. Deformities and or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- 7. Tumor
- 8. Failed previous fusion.

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate is intended to be used with autograft and or allograft as an adjunct to fusion.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage and a lumbo-sacral plate for degenerative conditions.

#### 6. Substantial equivalence claimed to predicate devices

MEDICREA® INTERNATIONAL Anterior Lumbosacral Plate is substantially equivalent to the Alphatec Spine Anterior Lumbar Plating System and Spinal USA anterior plate system, in terms of intended use, materials used, mechanical safety and performances, and the Pyramid in terms of intended use, design, materials used.

- The Alphatec Spine Anterior Lumbar Plating System, (Alphatec Spine, K101255) .
- The Spinal USA Anterior Lumbar Plate System (Spinal USA, K091044) ●
- . The Pyramid® +4 Anterior Lumbar Plate System (MEDTRONIC, K080429)

Pg 2 of 4

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K121323

The table below compares the features and characteristics of MEDICREA® INTERNATIONAL Anterior Lumbosacral Plate to these predicate devices.

| Device | STABOLT<br>Lumbo sacral<br>plate | ASPIDA<br>(Alphatec<br>Spine) | Lumbar Plate<br>(Spinal USA) | Pyramid +4<br>Anterior<br>lumbar plate<br>(Medtronic) |
|------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------|------------------------------------------|-------------------------------------------------------|
| 510(k)<br>number | | K101255 | K091044 | K080429 |
| Intended<br>use | | | | |
| Lumbar<br>spine<br>(L5/S1) | Yes | Yes | Yes | Yes |
| Anterior<br>Approach<br>below the<br>great vessel<br>bifurcation | Yes | Yes | Yes | Yes |
| Design<br>Anchorage<br>mean | 3 or 4 screws | 4 screws | 4 screws | 3 or 4 screws |
| Security<br>features | Screws clipped<br>within the<br>PEEK<br>OPTIMA® LT1<br>insert | Screws clipped<br>within the<br>titanium plate | Rotating anti-<br>out back<br>system | A cover plate |
| Shape | Triangular<br>shape | Rectangular<br>shape | Rectangular<br>shape | Triangular<br>shape |
| Materials | | | | |
| Stabilization<br>device | Ti-6Al-4V<br>(ASTM F136 &<br>ISO 5832-3) | Ti-6Al-4V<br>(ASTM F136 &<br>ISO 5832-3) | Ti-6Al-4V<br>(ASTM F136 &<br>ISO 5832-3) | Ti-6Al-4V<br>(ASTM F136 &<br>ISO 5832-3) |
| Security<br>features | PEEK<br>OPTIMA® LT1<br>(ASTM<br>F2026) | Ti-6Al-4V<br>(ASTM F136 &<br>ISO 5832-3) | Ti-6Al-4V<br>(ASTM F136 &<br>ISO 5832-3) | Ti-6Al-4V<br>(ASTM F136 &<br>ISO 5832-3) |

Material composition is identical to other MEDICREA® INTERNATIONAL products that have been cleared via the 510(k) process.

## 7. Non-clinical Test Summary:

Testing was performed on the MEDICREA® Anterior Lumbosacral Plate system following the protocols outlined in ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model".

The following tests were conducted:

- . Static axial Compression
- . Static torsion
- Dynamic compression .

### 8. Clinical Test Summary

No clinical studies were performed

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# 9. Conclusions Nonclinical and Clinical

-

MEDICREA® Anterior Lumbosacral Plate system is substantially equivalent to its predicate devices in terms of indications for use, design, material and function.

Ps 4 of 4

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medicrea International % Ms. Laure Aviron-Violet Regulatory Affairs Manager 14 Porte du Grand Lyon Neyron France 01700

Re: K121323

Trade/Device Name: Anterior Lumbo-Sacral Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 27, 2012 Received: May 02, 2012

Dear Ms. Aviron-Violet:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

JUL 188 2012

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Page 2 - Ms. Laure Aviron-Violet

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.

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/CDRH/CDRHOffices/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,

Erin Keith

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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K121323

### Statement of Indications for Use

510(k) Number (if known):

Device Name:

Lumbo-Sacral Plate

### Indications for Use:

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is designed to be used at L5/S1 level. It is intended for use as anteriorly placed supplemental fixation device surgical approach below the great vessel bifurcation. The device is intended as a temporary fixation device until fusion is achieved.

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is intended for anterior lumbar spine at L5/S1 level, for the following indications:

1. Degenerative Disc Disease (DDD) at L5/S1 level. (DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies)

- 2. Pseudoarthrosis
- 3. Spondylolysis

4. Trauma (i.e., fracture or dislocation)

- 5. Spinal stenosis
6. Deformities and or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

7. Tumor

8. Failed previous fusion.

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate is intended to be used with autograft and or allograft as an adjunct to fusion.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage and a lumbo-sacral plate for degenerative conditions.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K121323

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