(195 days)
Not Found
No
The 510(k) summary describes a mechanical implant (a titanium mesh cage) and its intended use and mechanical testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is described as a vertebral body replacement system intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture, aiding in spinal fusion. This directly aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The ENDURAMESH is described as a vertebral body replacement system, a physical implant used for structural support and spinal fusion, not for diagnosing conditions.
No
The device description explicitly states it is a "single cylindrically shaped titanium mesh cage," which is a physical hardware component. The performance studies also focus on mechanical testing of this hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ENDURAMESH Function: The ENDURAMESH is a surgical implant designed to replace a damaged vertebral body in the spine. It is a physical device used within the body, not a test performed on a sample outside the body.
The description clearly indicates it's a vertebral body replacement system used in surgery for structural support and spinal fusion. This falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / 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 may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Product codes
MQP
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 may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
The ENDURAMESH 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. Various diameters and heights are available to accommodate variability among patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine (T1-S1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following mechanical testing was performed per ASTM F2077 and ASTM F2267 to demonstrate substantial equivalence of the subject device to the predicate device: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the ENDURAMESH is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
DePuy Harms Mesh Cage (K003043)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.
0
510(k) Summary
Summary of 510(k) Safety and Effectiveness
| Submitted By: | Lucero Medical, LLC.
PO Box 67
Richfield, OH 44286 | APR 2 6 2010 |
|-----------------------------|----------------------------------------------------------|--------------|
| Date: | April 22, 2010 | |
| Contact Person: | Jennifer Palinchik
Project Manager | |
| Contact Telephone: | (440) 808-9995 | |
| Device Trade Name: | ENDURAMESH | |
| Device Classification Name: | Spinal intervertebral body fixation orthosis | |
| Device Classification: | Class II | |
| Reviewing Panel: | Orthopedic/87 | |
| Regulation Number: | 888.3060 | |
| Product Code: | MQP | |
| Predicate Devices: | DePuy Harms Mesh Cage (K003043) | |
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 may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
The ENDURAMESH 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. Various 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 may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Substantial Equivalence Information:
The design features, material, and indications for use of the ENDURAMESH system are substantially equivalent to the predicate devices listed above. The safety and effectiveness is adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.
Summary of Non-Clinical Tests:
The following mechanical testing was performed per ASTM F2077 and ASTM F2267 to demonstrate substantial equivalence of the subject device to the predicate device: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the ENDURAMESH is substantially equivalent to the predicate device.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing-like shapes, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 6 2010
Lucero Medical, LLC % Ms. Jennifer Palinchik Project Manager P.O. Box 67 Richfield, Ohio 44286
Re: K093207
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: April 12, 2010 Received: April 16, 2010
Dear Ms. Palinchik:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premained issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manietics promotive Americal Device Amendments, or to commerce prov to May 28, 1976, the enactiven assist of the Federal Food, Drug, devices that have been recuired in aver approval of a premarket approval application and Cosmetic Act (Act) market the device, subject to the general controls provisions of the (PMA). You may, therefore, market the Act include requirements for annual registration,
Act. The general controls provisions of the Act include requirements for annual regist Act. The general controls provisions of the rice habeling, and prohibitions against misbranding ilsting of devices, good manufacturing practice, in county in - information related to contract itability. and adulteration. Frease note: CDICI Goos not ovation must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or classics on be If your device is classified (see above) into than major regulations affecting your device can be may be subject to additional confrols. "Entraling and on 898. In addition, FDA may found in the Code of I each resgurerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a bacession with other requirements of the Act
that FDA has made a determination that your device complies with one and on anyat inal FDA has made a deciermination and your acceral by other Federal agencies. You must and ligit of any Federal statules and regulations administered of Callerial of registration and listing (21
2
Page 2 - Ms. Jennifer Palinchik
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI'N Fat 607), adoming (21 OFR 803); good manufacturing proctice requirements as set de vice-related adverse orents) (2) CFR Part 820); and if applicable, the electronic forth in the quality by crems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (1 CFR Patt 801), please IT you ucsire specific advice to: your conters Offices/CDRH/CDRHOffices/ucm115809.htm for go to nttp://www.lua.goff.rRadiological Health's (CDRH's) Office of Compliance. Also, please the Conter to: Doviete and , "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 r ou may obtain other general memational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Barbara Buekus
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K093207
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 may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
Prescription Use × (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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K093207 510(k) Number_
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