(88 days)
P95002
Not Found
No
The document describes a physical interbody fusion device made of polymer and metal markers. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML.
Yes.
The device is an interbody fusion device intended for use in patients with degenerative disc disease, which is a medical condition, and aims to provide structural stability and contribute to fusion, thereby treating the condition.
No
The device description states that the PATRIOT™ 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)." These devices are used to provide structural stability after discectomy, not to diagnose a condition.
No
The device description clearly states the device is made from radiolucent polymer with titanium alloy or tantalum markers, indicating it is a physical implant and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are "interbody fusion devices intended for use in patients with degenerative disc disease... to provide structural stability". This describes a surgical implant used to treat a physical condition.
- Device Description: The description details the physical characteristics of the spacers, their material composition, and how they function as structural support in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically tests or kits used in a laboratory or clinical setting to analyze biological samples.
This device falls under the category of a surgical implant or medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PATRIOT™ Spacers (Constitution™ PLIF. Continental TM ALIF. TransContinental™ LLIF and Signature™ TLIF 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).
PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
Product codes
MAX
Device Description
The PATRIOT™ Spacers (Constitution™ PLIF, Signature™ TLIF . Continental™ ALIF, and TransContinental™ LLIF Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. Each of the PATRIOT™ Spacers provides a different shape to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal, anterior). The devices 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™ Spacers are made from radiolucent polymer, with 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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P95002 BAK Interbody Fusion System
Reference Device(s)
Not Found
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
Page 1 of 2
JAN 18 2008
510(k) SUMMARY: PATRIOT™ SPACERS
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 |
|----------|-------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.
Director, Clinical Affairs & Regulatory |
PATRIOT™ Spacers: Device Name: Constitution™ PLIF Spacer Signature™ TLIF Spacer Continental™ ALIF Spacer TransContinental™ LLIF Spacer
- Classification: Product Code MAX. Class II. 21 CFR §888.3080 Intervertebral body fusion device
P95002 BAK Interbody Fusion System Predicate(s):
Device Description:
The PATRIOT™ Spacers (Constitution™ PLIF, Signature™ TLIF . Continental™ ALIF, and TransContinental™ LLIF Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. Each of the PATRIOT™ Spacers provides a different shape to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal, anterior). The devices 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™ Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.
Intended Use:
Spacers Continental™ PLIF. PATRIOT™ ALIF. TransContinental™ LLIF and Signature™ TLIF 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).
1
PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
Basis for Substantial Equivalence:
PATRIOT™ Spacers have been evaluated in accordance with the "Class_!! Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007 and have been found to meet the criteria set forth in the guidance document in terms of indications, design, and performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2008
Globas Medical Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, PA 19403
Re: K072970
Trade/Device Name: PATRIOTTM Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: October 19, 2007 Received: October 22, 2007
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 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Milhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number: | K072970 |
|---|---|
| Device Name: | PATRIOT TM Spacers |
Indications:
(Constitution™ PLIF. Continental TM ALIF. PATRIOT™ Spacers TransContinental™ LLIF and Signature™ TLIF 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).
PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
OR
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mellers
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
519(k) Number