(109 days)
PATRIOT® TransContinental LLIF Spacers K093242
No
The summary describes a passive interbody fusion device made of PEEK and titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes.
The device is an interbody fusion device used to treat degenerative disc disease and provide structural stability in the lumbosacral spine, which makes it a therapeutic device.
No.
The device is an interbody fusion device intended for surgical implantation to provide structural stability in the spine, not to diagnose a condition.
No
The device description clearly states the device is made from PEEK polymer with integrated titanium and tantalum components, indicating it is a physical implant, not software.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The PATRIOT® TransContinental™ M Spacers are physical implants designed to be surgically inserted into the spine to provide structural support and facilitate bone fusion. They do not analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by providing structural stability and promoting fusion, not by analyzing biological markers.
The provided information describes a medical device used in vivo (within the body) for a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The PATRIOT® TransContinental™ M Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
Product codes
MAX
Device Description
The PATRIOT® TransContinental® M Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The PATRIOT® TransContinental® M implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1)
Indicated Patient Age Range
skeletally mature
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, static and dynamic compression-shear, and subsidence) was conducted in accordance with ASTM F2077 and F2267, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, and "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007. Performance data demonstrate substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
PATRIOT® Lumbar Spacers K072970
Reference Device(s)
PATRIOT® TransContinental LLIF Spacers K093242
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
510(k) SUMMARY: PATRIOT® TransContinental™ M Spacer
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 930-1800 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D
Director, Clinical Affairs & Regulatory |
| Date Prepared: | August 13, 2010 |
| Device Name: | PATRIOT® TransContinental™ M Spacer |
| Classification: | Per 21 CFR as follows:
§888.3080 Intervertebral Body Fusion Device
Product Code MAX.
Regulatory Class II, Panel Code 87 |
| Predicate(s): | PATRIOT® Lumbar Spacers K072970 |
- PATRIOT® Lumbar Spacer SE date January 18, 2008 PATRIOT® TransContinental LLIF Spacers K093242 SE date December 23, 2009
Purpose:
The purpose of this submission is clearance of the PATRIOT® TransContinental® M Spacer, a component of the PATRIOT® family of lumbar interbody fusion spacers.
Device Description:
The PATRIOT® TransContinental® M Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The PATRIOT® TransContinental® M implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.
Indications for Use:
more TransContinental™ M Spacers are interbody fusion devices intended I ATRIOT Transoonlinental - m extient disc disease (DDD) at one or two for use in patients with degeneral spine (L2-S1). DDD is defined as
1
discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
Performance Data:
Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) was conducted in accordance with ASTM F2077 and F2267, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, and "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007. Performance data demonstrate substantial equivalence to the predicate device.
Basis for Substantial Equivalence:
The PATRIOT® TransContinental™ M Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three wing-like shapes, positioned to the right of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Globus Medical, Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs and Regulatory Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
DEC - 3 2010
Re: K102313
Trade/Device Name: PATRIOT® TransContinental™ M Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 29, 2010 Received: November 30, 2010
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 Mav 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. Ilsting 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.
3
Page 2 - Kelly J. 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); 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.hym 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 vours.
Sincerely yours,
For Peter
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical; Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K102313
Indications for Use Statement
DEC - 3 2010
510(k) Number:
PATRIOT® TransContinental™ M Spacer Device Name:
Indications:
The PATRIOT® TransContinental™ M Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
OR
x 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)
Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K102313 510(k) Number_
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