(82 days)
Not Found
No
The summary describes a purely mechanical implant device with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is a vertebral body replacement device used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which directly treats or alleviates a medical condition.
No
The device is described as a "vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture)". This indicates it is a therapeutic device, not a diagnostic one. There is no mention of it being used to detect, monitor, or diagnose a condition.
No
The device description clearly states it is a vertebral body replacement device made from physical materials like titanium alloy and PEEK, and includes components like a central core, endplates, and screws. This indicates a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the FORTIFY™ Integrated Corpectomy Spacers as implantable devices used to replace vertebral bodies in the spine. They are surgically placed within the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the FORTIFY™ Integrated Corpectomy Spacers are not IVDs. They are surgical implants.
N/A
Intended Use / Indications for Use
FORTIFY™ Integrated Corpectomy Spacers (FORTIFY™ I and FORTIFY™ I-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
FORTIFY™ and FORTIFY™ Intearated Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY™ Integrated endplates have an integrated plate to accommodate screws for additional fixation, and are assembled to the core.
FORTIFY™ and FORTIFY™ I Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY™-R and FORTIFY™ I-R Corpectomy Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxvapatite coating per ASTM F1185.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature individuals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing (static & dynamic compression, static & dynamic torsion, expulsion, and screw pushout) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F2077 to demonstrate substantial equivalence to the predicate system(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 3 2012 510(k) Summary: FORTIFY™ I Corpectomy Spacers
| Company: | Globus Medical Inc. |
|---|---|
| 2560 General Armistead Ave. | |
| Audubon, PA 19403 | |
| (610) 930-1800 | |
| Contact: | Sarah Marie Fitzgerald |
| Project Manager, Regulatory Affair |
Date Prepared: May 31, 2012
- Device Name: FORTIFY Integrated Corpectomy Spacers (FORTIFY™ I and FORTIFY™ I-R)
Classification: Per 21 CFR as follows: §888.3060 Implant, fixation, spinal intervertebral body fixation
orthosis devices Product Code MQP. Regulatory Class II, Panel Code 87.
Purpose:
The purpose of this submission is to request clearance for the FORTIFY Integrated Corpectomy Spacers.
Device Description:
FORTIFY™ and FORTIFY™ Intearated Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY™ Integrated endplates have an integrated plate to accommodate screws for additional fixation, and are assembled to the core.
FORTIFY™ and FORTIFY™ I Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY™-R and FORTIFY™ I-R Corpectomy Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxvapatite coating per ASTM F1185.
1
Indications for Use:
FORTIFY™ Integrated Corpectomy Spacers (FORTIFY™ I and FORTIFY™ I-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Performance Data:
Mechanical testing (static & dynamic compression, static & dynamic torsion, expulsion, and screw pushout) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F2077 to demonstrate substantial equivalence to the predicate system(s).
Basis of Substantial Equivalence:
FORTIFY™ Integrated Corpectomy Spacers implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacer to the predicate device(s).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three wave-like lines below the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
. JUL 3 2012
Globus Medical, Inc. % Ms. Sarah Marie Fitzgerald Project Manager, Regulatory Affairs 2560 General Armistead Ave. Audobon, Pennsylvania 19403
Re: K121107
Trade/Device Name: FORTIFY Integrated Corpectomy Spacers (FORTIFY I and FORTIFY I-R) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 4, 2012 Received: June 5, 2012
Dear Ms. Fitzgerald:
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.
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Page 2- Ms. Sarah Marie Fitzgerald
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millam
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 Statement
K121107 510(k) Number:
FORTIFY™ Integrated Corpectomy Spacers Device Name:
Indications:
FORTIFY™ Integrated Corpectomy Spacers (FORTIFY™ I and FORTIFY™ I-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Prescription Use × (Per 21 CFR §801.109) Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diysion Sign-Off) Dission of Surgical, Orthopedic, and Restorative Devices
KI21107 510(k) Number_