(57 days)
Not Found
No
The 510(k) summary describes a passive, mechanical implant (a vertebral body replacement device) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device description focuses on materials, dimensions, and mechanical function.
Yes
The device is described as a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, providing anterior spinal column support. These are therapeutic interventions aimed at treating a medical condition.
No
Explanation: This device is a vertebral body replacement intended for structural support in the thoracolumbar spine (T1-L5), not for diagnosis.
No
The device description explicitly states it is comprised of physical components made from radiolucent polymer, titanium alloy, and tantalum, which are hardware materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The XPand Radiolucent Corpectomy Spacer is a physical implant designed to replace a vertebral body in the spine. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use is to provide structural support in the spine after the removal of a damaged vertebral body. This is a therapeutic/reconstructive purpose, not a diagnostic one.
The device is clearly an implantable surgical device used for structural support in the spine.
N/A
Intended Use / Indications for Use
The XPand Radiolucent Corpectomy Spacer is a vertebral body replacement device 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). The XPand Radiolucent Corpectomy Spacer is 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 spacer can be packed with bone grafting material. The XPand Radiolucent Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Product codes
MQP
Device Description
The XPand Radiolucent Corpectorny Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion. The XPand devices are made from radiolucent polymer, titanium alloy, and tantalum as specified in F2026. F136, F136, F1295, and F560.
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 in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(K) Summary III.
SUBMITTED BY:
144 1 0 0000005
Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 Contact: Kelly J. Baker
DEVICE NAME:
XPand Radiolucent Corpectomy Spacer
CLASSIFICATION:
Per CFR 21 §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. The Product Code is MQP. The Panel Code is 87.
PREDICATE DEVICES:
Globus XPand Corpectomy Spacer K050850, SE date May 26, 2005 Globus Sustain Radiolucent Spacer K040284. SE date March 23, 2004
DEVICE DESCRIPTION:
The XPand Radiolucent Corpectorny Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.
The XPand devices are made from radiolucent polymer, titanium alloy, and tantalum as specified in F2026. F136, F136, F1295, and F560.
1
INTENDED USE:
The XPand Radiolucent Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The XPand Radiolucent Corpectomy Spacer is 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 spacer can be packed with bone grafting material.
The XPand Radiolucent Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
PERFORMANCE DATA:
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The XPand Radiolucent Corpectomy Spacer implants are similar to the predicate vertebral body replacement device, XPand Corpectorny Spacer (K050850), with respect to functional design, indications for use, principles of operation, and performance. The material is changed to a radiolucent polymer that is being used in other legally marketed devices within the same classification regulation for the same intended use as the XPand Radiolucent Corpectomy Spacer.
2
II. Indications for Use Statement
| 510(k) Number: | K060665 |
|---|---|
| Device Name: | XPand Radiolucent Corpectomy Spacer |
Indications:
The XPand Radiolucent Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The XPand Radiolucent Corpectorny Spacer is 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 spacer can be packed with bone grafting material.
The XPand Radiolucent Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
OR
Prescription Use __ X ____ (Per 21 CFR §801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures intertwined. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2006
Globus Medical Incorporated c/o Kelly Baker, Ph.D. Project Manager, Regulatory Affairs 303 Schell Lane Phoenixville, Pennsylvania 19460
Re: K060665
Trade Name: XPand Radiolucent Corpectomy Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 12, 2006 Received: April 13, 2006
Dear Dr. Baker:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Kelly Baker, Ph.D.
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Helmut Lerner nos
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number: | K060665 |
|---|---|
| ---------------- | --------- |
Device Name: XPand Radiolucent Corpectomy Spacer
Indications:
The XPand Radiolucent Corpectomy Spacer is a vertebral body replacement device 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). The XPand Radiolucent Corpectomy Spacer is 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 spacer can be packed with bone grafting material.
The XPand Radiolucent Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Prescription Use × (Per 21 CFR §801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Lemer MD
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060665