(29 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not algorithm performance evaluations.
Yes
The device is described as a spinal system intended for stabilization of the cervical spine and occipito-cervico-thoracic junction in skeletally mature patients as an adjunct to fusion for various conditions, which are all therapeutic interventions.
No
Explanation: This device is a spinal system (implants) used as an adjunct to fusion for stabilization. Its purpose is to treat conditions rather than diagnose them.
No
The device description explicitly lists hardware components such as rods, screws, hooks, and plates, and discusses their materials and mechanical testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is described as a system of implants (rods, screws, hooks, plates, etc.) made of various metals. These are physical devices intended for surgical implantation.
- Intended Use: The intended use is for stabilization of the spine as an adjunct to fusion, addressing conditions like degenerative disc disease, fractures, tumors, etc. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX® or REVERE® or BEACON® Systems, using corresponding connectors.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm iointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps. t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps and occipital plates. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537). Due to the risk of galvanic corrosion following implantation, titanium alloy or CoCr implants should not be connected to stainless steel implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipito-cervico-thoracic junction (occiput-T3), upper thoracic spine (T1-T3), occipital
Indicated Patient Age Range
skeletally mature patients
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 (static and dynamic compression bending and static and dynamic torsion) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F1717 to demonstrate substantial equivalence to the predicate system(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K090565, K050391, K081906, K100788, K103100
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
MAY - 5 2011
510(k) Summary: ELLIPSE® Additional Implants
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 930-1800 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D
Vice President, Clinical Affairs & Regulatory |
| Date Prepared: | April 5, 2011 |
| Device Name: | ELLIPSE® Occipito-Cervico-Thoracic Spinal System |
| Classification: | Per 21 CFR as follows:
§888.3050 Spinal Interlaminal Fixation Orthosis
Product Code KWP.
Regulatory Class II, Panel Code 87. |
| Predicate(s): | ELLIPSE® Occipito-Cervico-Thoracic Spinal System (K090565),
PROTEX® CT Cervicothoracic Spinal System (K050391 & K081906), CoCr Rods (K100788) & DePuy Spine Mountaineer |
OCT Spinal System (K103100)
Purpose:
The purpose of this submission is the addition of multiple components and the material cobalt chromium molybdenum alloy to the ELLIPSE® Occipito-Cervico-Thoracic Spinal System.
Device Description:
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm iointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps. t-connectors, lateral connectors, parallel connectors, in-line connectors, rod-to-rod connectors, rod extension clamps and occipital plates. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum alloy (CoCr) (per ASTM F1537). Due to the risk of galvanic corrosion following implantation, titanium alloy or CoCr implants should not be connected to stainless steel implants.
Indications for Use:
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis,
Page 1 of 2
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fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX®, REVERE®, or BEACON® Stabilization Systems, using corresponding connectors.
Performance Data:
Mechanical testing (static and dynamic compression bending and static and dynamic torsion) was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F1717 to demonstrate substantial equivalence to the predicate system(s).
Basis of Substantial Equivalence:
The ELLIPSE® Additional Implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate device(s).
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2
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 eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 5 2011
Globus Medical, Inc. % Kelly J. Baker Ph.D. VP. Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K110963
Trade/Device Name: ELLIPSE® Occipito-Cervico-Thoracic Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: April 5, 2011 Received: April 6, 2011
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. Ilisting 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
3
Page 2 - Kelly J. Baker Ph.D.
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/ReportalProblem/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 your
Fic. D. Noli.
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
K110963 510(k) Number:
ELLIPSE® Additional Implants Device Name:
Indications:
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
The ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX® or REVERE® or BEACON® Systems, using corresponding connectors.
Prescription Use × (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)
_
(Division Sign-Off)_
Division of Surgical, Orthopedic, and Restorative Devices
KI10963 510(k) Number_