(143 days)
No
The document describes a physical interbody fusion device made of PEEK and titanium, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is an interbody fusion device that provides structural stability and is intended for use with supplemental fixation, rather than actively providing a therapeutic effect itself.
No
The device description states that PATRIOT® Spacers are "lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly states that the PATRIOT® Spacers are physical implants made from PEEK polymer and titanium/tantalum, intended for surgical implantation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the PATRIOT® Spacers are "interbody fusion devices intended for use in patients with degenerative disc disease...". This describes a surgical implant used to treat a condition within the body.
- Device Description: The description details the physical characteristics of the spacers, their materials, and how they are inserted into the spine. This aligns with a medical device used for structural support and fusion.
- 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, etc.) to provide information for diagnosis, monitoring, or compatibility.
IVD devices are used in vitro (outside the body) to analyze samples. The PATRIOT® Spacers are used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and 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).
PATRIOT® 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
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, and TransContinental® and TransContinental® M Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. The Constitution® PLIF Spacer is inserted using a posterior approach. The Signature® TLIF Spacer is inserted using a transforaminal approach. The Continental® ALIF Spacer is inserted using an anterior approach. The Transcontinental® and Transcontinental® M Spacers are inserted using an anterior or lateral approach. 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 PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). The Signature® R Spacer also includes an internal titanium alloy or commercially pure titanium (ASTM F67) component, and the TransContinental® M Spacer also includes an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Confirmatory static compression testing was conducted in accordance with ASTM F2077-03 with the subject device meeting all acceptable criteria. An engineering rationale was provided to demonstrate equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3080 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.
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K122097 Page 1 of 2
510(k) SUMMARY: PATRIOT® SPACERS
DEC 0 6 2012
Company:
Globus Medical Inc. 2560 General Armistead Avenue Audubon, PA 19403 (610) 930-1800
Christina Kichula Contact: Group Manager, Regulatory Affairs
Date Prepared: July 13, 2012
Device Name: PATRIOT® Spacers
Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Devices. Product Code: MAX. Regulatory Class II, Panel Code: 87.
PATRIOT® Spacers (K072970, K093242, & K102313) Predicate(s): RISE™ (K113447)
Purpose:
The purpose of this submission is to request clearance for additional Signature® spacers with a modified articulation mechanism, additional Signature® spacers manufactured from titanium, and sterile lumbar PATRIOT® spacers.
Device Description:
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, and TransContinental® and TransContinental® M Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. The Constitution® PLIF Spacer is inserted using a posterior approach. The Signature® TLIF Spacer is inserted using a transforaminal approach. The Continental® ALIF Spacer is inserted using an anterior approach. The Transcontinental® and Transcontinental® M Spacers are inserted using an anterior or lateral approach. 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 PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). The Signature® R Spacer also includes an internal titanium alloy or commercially pure titanium (ASTM F67)
1
component, and the TransContinental® M Spacer also includes an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295).
Indications for Use:
Indications Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and 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).
PATRIOT Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
Technological Characteristics:
The technological characteristics of the PATRIOT® Spacer additional implants are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.
Basis for Substantial Equivalence:
The PATRIOT® Spacer additional implants are similar to the predicate devices with respect to technical characteristics, material, performance, and intended use. Confirmatory static compression testing was conducted in accordance with ASTM F2077-03 with the subject device meeting all acceptable criteria. An engineering rationale was provided to demonstrate equivalence to the predicate device. Therefore, the information provided within this premarket notification supports substantial equivalence to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 graphic element to the right, which resembles an abstract human form or a symbol representing health and well-being. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion, with the words following the curve of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 6, 2012
Globus Medical, Incorporated % Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Avenue Valley Forge Business Center Audubon. Pennsylvania 19403
Re: K122097
Trade/Device Name: PATRIOT® Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 06, 2012 Received: November 07, 2012
Dear Ms. Kichula:
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 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
3
Page 2 - Ms. Christina Kichula
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/CentersOfficcs/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/ResourcesforYou/Industry/default.htm.
Sincerely yours, Erin I. Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K122097 510(k) Number:
PATRIOT® Spacers Device Name:
Indications:
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and 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).
PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
OR
Prescription Use X (Per 21 CFR §801.109)
O
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)
Caroline Rhim -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122097