(52 days)
No
The 510(k) summary describes a purely mechanical implant (a corpectomy spacer) made of titanium alloy. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithm validation.
Yes
The device replaces part of the spine affected by tumor or trauma, aiming to restore stability and function to the body, thus serving a therapeutic purpose.
No
The device is a corpectomy spacer used to replace a damaged or unstable vertebral body, providing structural support. It is a treatment device, not a diagnostic one.
No
The device is a physical implant made of titanium alloy, intended for surgical implantation in the spine. It is 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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- XPAND Corpectomy Spacer Function: The XPAND Corpectomy Spacer is a physical implant designed to replace a damaged vertebral body in the spine. It provides structural support and is used in surgical procedures. It does not analyze biological specimens.
The description clearly indicates it's a surgical implant for structural support in the spine, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XPAND 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 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 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 CORPECTOMY SPACER 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 fixed 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 Corpectomy Spacer devices are made from titanium alloy as specified in ASTM F1295 and F136.
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
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 was presented.
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
MAY 2 6 2005 .
III. 510(K) Summarv
SUBMITTED BY:
Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker
DEVICE NAME:
XPAND 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 Sustain Spacer K031302, SE date June 27, 2003
DEVICE DESCRIPTION:
The XPAND CORPECTOMY SPACER 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 fixed 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 Corpectomy Spacer devices are made from titanium alloy as specified in ASTM F1295 and F136.
INTENDED USE:
The XPAND 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 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
1
anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The XPAND 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 was presented.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The XPAND Corpectomy Spacer implants are similar to the predicate vertebral body replacement device, the Sustain Spacer (K031302), with respect to functional design, indications for use, principles of operation, and performance. The design is changed to an expandable spacer that is being used within the same classification regulation for the same intended use as the Sustain Spacer.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2005
Kelly Baker, Ph.D. Project Manager, Regulatory Affairs Globus Medical Incorporated 303 Schell Lane Phoenixville, Pennsylvania 19460
Re: K050850
Trade Name: XPAND Corpectomy Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: May 3, 2005 Received: May 4, 2005
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 includions 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, intern 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, TDA max publish further announcements concerning your device in the Federal Register.
3
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.
A. Hyyt Rlrode
Minister-President, Ph.D.
Provost Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ll. Indications for Use Statement
| 510(k) Number: | K050850 |
|---|---|
| Device Name: | XPAND Corpectomy Spacer |
Indications:
The XPAND 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 Corpectomy Spacer is intended to be used with supplemented 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 Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
OR
Prescription Use × (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)
At. Elvode
Division of General, Restorative, and Neurological Devices
510(k) Number_KO 50 850