(137 days)
Not Found
No
The summary describes a mechanical fixation system (plates and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as a 'Laminoplasty Fixation System' used to 'hold the bone allograft material in place' to 'prevent the allograft from expulsion, or impinging the spinal cord' in a surgical procedure, which indicates a therapeutic purpose.
No
The provided text describes the RELIEVE™ Laminoplasty Fixation System as a device for holding bone allograft material in place during laminoplasty procedures. Its function is mechanical fixation, not to diagnose a condition or disease.
No
The device description explicitly states it consists of physical components: spinal fixation plates and screws made from polymer and titanium/tantalum alloys. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure involving the fixation of bone allograft in the spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device consists of physical implants (plates and screws) made from materials like polymer and titanium, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The RELIEVE™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE™ Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord.
Product codes
NQW
Device Description
The RELIEVE™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. RELIEVE™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Plates may be filled with bone graft material. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.
RELIEVE™ plates are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. Screws are made from titanium alloy, as specified in F136 and F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
K080664 (pg. 1 of 1)
510(k) SUMMARY: RELIEVE™ Laminoplasty Fixation System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 | JUL 2 5 2008 |
|-----------------|---------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Kelly J. Baker, Ph.D
Director, Clinical Affairs & Regulatory | |
| Device Name: | RELIEVE™ Laminoplasty Fixation System | |
| Classification: | Product Code NQW. Class II.
21 CFR §888.3050 Spinal interlaminal fixation orthosis. | |
| Predicate(s): | Medtronic Sofamor Danek CENTERPIECE Plate Fixation
System K050082; Blackstone Laminoplasty Fixation System | |
DEVICE DESCRIPTION:
The RELIEVE™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. RELIEVE™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Plates may be filled with bone graft material. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.
K043338, and Synthes Arch Fixation System K032534.
RELIEVE™ plates are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. Screws are made from titanium alloy, as specified in F136 and F1295.
INTENDED USE:
The RELIEVE™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE™ Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord.
Basis for Substantial Equivalence:
RELIEVE™ Laminoplasty Fixation System is similar in terms of indications, design, materials, and performance, to currently marketed devices.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars extending from its back, representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.
JUL 2 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Globus Medical, Inc % Kelly J. Baker, Ph.D. Director, Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K080664
Trade/Device Name: RELIEVE™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: May 30, 2008 Received: June 02, 2008
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.
2
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 prodicate 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-frec number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
| 510(k) Number: | K080664 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
|---|---|---|---|---|
RELIEVE™ Laminoplasty Fixation System Device Name:
INDICATIONS:
The RELIEVE™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures, The RELIEVE™ Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impioging the spinal cord.
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)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
N
(Division Sign-Off) Division of General, Restorative, and Neurological Devi 510(k) Number