(93 days)
K/DEN number: Not Found
No
The 510(k) summary describes a mechanical implant system and its intended use, with performance studies focused on mechanical testing. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies.
No
The device is a PLYMOUTH™ Thoracolumbar Plate System, which is an implant used for spinal fixation, not a therapeutic device in itself.
No
Explanation: The device is a thoracolumbar plate system used to treat spine instability, not to diagnose medical conditions.
No
The device description clearly states it consists of rigid plates and bone screws made of titanium alloy, which are physical hardware components intended for surgical implantation.
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.
- PLYMOUTH™ Thoracolumbar Plate System Function: The description clearly states that this system is a surgical implant used to stabilize the spine. It is physically implanted into the body and does not analyze biological specimens.
The information provided describes a surgical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The PLYMOUTH™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
Product codes
KWQ
Device Description
The PLYMOUTH™ Thoracolumbar Plate System consists of rigid plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). These implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1-L5) spine
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
Mechanical testing (static and dynamic compression bending and static torsion) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 to demonstrate substantial equivalence to the predicate system.
Key Metrics
Not Found
Predicate Device(s)
TRUSS® Thoracolumbar Plate System (K092108), Nuvasive Lateral Plate System (K091071)
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
APR 1 3 2012
20097
510(k) Summary: PLYMOUTH™ Thoracolumbar Plate System
| Company: | Globus Medical Inc.
Valley Forge Business Center
2560 General Armistead Avenue
Audubon, PA 19403
(610) 930-1800 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Marie Fitzgerald
Project Manager, Regulatory Affairs |
| Date Prepared: | January 10, 2012 |
| Device Name: | PLYMOUTH™ Thoracolumbar Plate System |
| Classification: | Per 21 CFR as follows:
§888.3060: Spinal Intervertebral Body Fixation Orthosis
Product Code: KWQ.
Regulatory Class: II, Panel Code: 87. |
| Predicate(s): | TRUSS® Thoracolumbar Plate System (K092108)
SE date: August 13, 2009
Nuvasive Lateral Plate System (K091071) |
Purpose:
The purpose of this submission is to request clearance for the PLYMOUTH™ Thoracolumbar Plate System.
Device Description:
The PLYMOUTH™ Thoracolumbar Plate System consists of rigid plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). These implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.
Indications for Use:
The PLYMOUTH™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
1
120097
Performance Data:
Mechanical testing (static and dynamic compression bending and static torsion) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 to demonstrate substantial equivalence to the predicate system.
Basis of Substantial Equivalence:
The PLYMOUTH™ Thoracolumbar Plate System is similar to the predicate devices with respect to technical characteristics, design, materials, performance, and intended use. The information provided within this premarket notification supports substantial equivalence 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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Globus Medical Incorporated % Ms. Sarah Marie Fitzgerald Project Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K120092
Trade/Device Name: PLYMOUTH™ Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 19, 2012 Received: March 20, 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.
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
APR 1 3 2012
3
Page 2 - Ms. April Lee
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,
Eunel Keith
for 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
510(k) Number:
Device Name:
PLYMOUTH™ Thoracolumbar Plate System
Indications:
The PLYMOUTH™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
OR Over-The-Counter Use Prescription Use × (Per 21 CFR §801.109)
(PLEASE DO NOT WRITE ON THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical Orthopedic, and Restorative Devices
K120092 510(k) Number