(22 days)
Not Found
No
The 510(k) summary describes a purely mechanical vertebral body replacement system made of titanium mesh. There is no mention of software, algorithms, image processing, AI, or ML.
No
The device is described as a vertebral body replacement system, which provides structural support and aids in spinal fusion. This falls under the category of a surgical implant rather than a therapeutic device that directly treats a condition through non-surgical means or delivers a therapy. While it helps resolve a physical issue, its primary function is mechanical support.
No
The "Intended Use / Indications for Use" section states that the device is a "vertebral body replacement system" for structural support and fusion, not for diagnosing conditions.
No
The device description clearly states it is a "single cylindrically shaped titanium mesh cage," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- ENDURAMESH Function: The ENDURAMESH is a physical implant designed to replace a damaged vertebral body in the spine. It provides structural support and aids in spinal fusion. It does not analyze biological samples to provide diagnostic information.
The description clearly indicates it's a surgical implant used in vivo (within the body) for structural support, not a test performed in vitro (outside the body) on biological samples.
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 must be used with a cleared supplemental fixation system.
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 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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
K122622
page 1 of 2
1 9 2012
510(k) Summary
Summary of 510(k) Safety and Effectiveness
| Submitted By: | Lucero Medical, LLC
P.O. Box 67
Richfield, OH 44286 |
|-----------------------------|-------------------------------------------------------------|
| Date: | August 24, 2012 |
| Contact Person: | Jennifer Palinchik
Development and Regulatory Consultant |
| Contact Telephone: | (440) 933-8850 |
| 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.
1
Predicate Comparison Chart:
| Item | ENDURAMESH | Modified ENDURAMESH |
|---|---|---|
| Product Code | MQP | MQP |
| Classification Name | Spinal intervertebral body | |
| fixation orthosis | Same | |
| Intended Use | 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. | Same | |
| Diameter | 13mm | Same |
| Height | 7mm-33mm (2mm | |
| increments), 41mm-53mm | ||
| (2mm increments), 90mm | Same, plus 35mm, 37mm, | |
| 39mm | ||
| Material | Titanium Alloy | Same |
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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_