ENDURAMESH

K122622 · Lucero Medical, LLC · MQP · Sep 19, 2012 · Orthopedic

Device Facts

• Record ID: K122622
• Device Name: ENDURAMESH
• Applicant: Lucero Medical, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Sep 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device must be used with a cleared supplemental fixation system.

Device Story

ENDURAMESH is a vertebral body replacement system; cylindrical titanium mesh cage; provides structural support following anterior or far lateral corpectomy; aids spinal fusion. Hollow core allows packing with bone graft; circular holes promote fusion. Used in thoracic and lumbar spine (T1-S1). Operated by surgeons in clinical/OR settings. Requires concurrent use of cleared supplemental fixation system. Device accommodates patient variability via multiple diameter and height options. Benefits patient by stabilizing spine after vertebral body loss.

Clinical Evidence

No clinical data. Substantial equivalence supported by design analysis and material information.

Technological Characteristics

Cylindrically shaped titanium alloy mesh cage. Hollow core for bone graft packing. Available in various diameters and heights. Requires supplemental fixation. Non-active, mechanical implant.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracic and lumbar spine (T1-S1) resulting from tumor or trauma/fracture. Requires use with supplemental fixation and bone graft (allograft or autograft).

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

• Lucero Medical, LLC ENDURAMESH (K093207)

Submission Summary (Full Text)

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K122622
page 1 of 2

1 9 2012

# 510(k) Summary

Summary of 510(k) Safety and Effectiveness

| Submitted By: | Lucero Medical, LLC<br>P.O. Box 67<br>Richfield, OH 44286 |
|-----------------------------|-------------------------------------------------------------|
| Date: | August 24, 2012 |
| Contact Person: | Jennifer Palinchik<br>Development and Regulatory Consultant |
| Contact Telephone: | [phone] |
| Device Trade Name: | ENDURAMESH |
| Device Classification Name: | Spinal intervertebral body fixation orthosis |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number: | 888.3060 |
| Product Code: | MQP |
| Predicate Device: | Lucero Medical, LLC ENDURAMESH (K093207) |

## Device Description:

The ENDURAMESH is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device must be used with a cleared supplemental fixation system.

The EDURAMESH vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions diameters and heights are available to accommodate variability among patients.

### Indications for Use:

The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft. The device must be used with a cleared supplemental fixation system.

## Substantial Equivalence Information:

The design features, material, and indications for use of the ENDURAMESH system are substantially equivalent to the predicate device listed above. The safety and effectiveness is adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.

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Predicate Comparison Chart:

| Item | ENDURAMESH | Modified ENDURAMESH |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Product Code | MQP | MQP |
| Classification Name | Spinal intervertebral body<br>fixation orthosis | Same |
| Intended Use | for use in the thoracic and<br>lumbar spine (T1-S1) to<br>replace a collapsed,<br>damaged, or unstable<br>vertebral body due to tumor<br>or trauma/fracture. | Same |
| Diameter | 13mm | Same |
| Height | 7mm-33mm (2mm<br>increments), 41mm-53mm<br>(2mm increments), 90mm | Same, plus 35mm, 37mm,<br>39mm |
| Material | Titanium Alloy | Same |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

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

Lucero Medical, LLC % Ms. Jennifer Palinchik Development and Regulatory Consultant P.O. Box 67 Richfield, Ohio 44286

Re: K122622

Trade/Device Name: ENDURAMESH Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 24, 2012 Received: August 28, 2012

Dear Ms. Palinchik:

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 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

SEP 19 2012

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## Page 2 - Ms. Jennifer Palinchik

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/ResourcesforYou/Industry/default.htm. .

Sincerely vours.

Sincerely yours,

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): ¥122622

Device Name: ENDURAMESH

### Indications for Use:

The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device must be used with a cleared supplemental fixation system.

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

Over-The-Counter Use (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)

Califf

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

长122622 710(k) Number_