(21 days)
Not Found
No
The device description and intended use focus on a physical implant for spinal support, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device replaces a collapsed, damaged, or unstable vertebral body and provides structural stability and support, but it does not treat or cure a disease or medical condition.
No
This device is a vertebral body replacement device, intended for structural support, 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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Retain Radiolucent Spacer is a surgical implant designed to replace a damaged vertebral body in the spine. It is a structural device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states it's for replacing a vertebral body due to tumor or trauma and providing structural support. This is a surgical intervention, not a diagnostic test.
- Device Description: The description details the materials and design of a physical implant, not a testing kit or analytical instrument.
The information provided describes a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Retain Radiolucent 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 Retain Radiolucent 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 Retain Radiolucent 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 Retain Radiolucent 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 large open area to allow grafting material to be packed inside of the spacer. Ridges on the superior and inferior surfaces of each device help to grip the endplates of the adjacent vertebrae to resist expulsion.
The Retain Radiolucent Spacer devices are made from radiolucent polymer, titanium alloy and tantalum as specified in ASTM F2026, 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
Prescription Use
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 was 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
III. 510(K) Summary
SUBMITTED BY:
Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker
JUN - 8 2006
DEVICE NAME:
Retain Radiolucent 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:
Sustain Radiolucent Spacer K040284, SE date March 23, 2004
DEVICE DESCRIPTION:
The Retain Radiolucent 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 large open area to allow grafting material to be packed inside of the spacer. Ridges on the superior and inferior surfaces of each device help to grip the endplates of the adjacent vertebrae to resist expulsion.
The Retain Radiolucent Spacer devices are made from radiolucent polymer, titanium alloy and tantalum as specified in ASTM F2026, F136, F1295, and F560.
INTENDED USE:
The Retain Radiolucent 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 Retain Radiolucent 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
1
systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The Retain Radiolucent 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 Retain Radiolucent Spacer implants are similar to the predicate vertebral body replacement device, Sustain Radiolucent Spacer (K040284), with respect to functional design, indications for use, principles of operation, and performance.
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 AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures facing to the right, represented by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2006
Globus Medical, Inc. % Kelly J. Baker, Ph.D. Director, Regulatory and Clinical Affairs 303 Schell Lane Phoenixville, Pennsylvania 19460
Re: K061380
Trade/Device Name: Retain Radiolucent Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: May 17, 2006 Received: May 18, 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.
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.
3
Page 2 - Kelly J. Baker, Ph.D.
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,
Heiker Lemons
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 - Kelly J. Baker, Ph.D.
Indications for Use
11 11 11
510(k) Number (if known):
Device Name:
Indications For Use:
Prescription Use AND/OR Over-The-Counter Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
5
Indications for Use Statement ll.
| 510(k) Number: | K061380 |
|---|---|
| ---------------- | --------- |
Device Name: Retain Radiolucent Spacer
Indications:
The Retain Radiolucent 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 Retain Radiolucent 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 Retain Radiolucent 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)
Helent Pemer
Division of General, Restorative, and Neurological Devices
510(k) Number Ko61380