(168 days)
No
The document describes a mechanical spinal fixation device and its components, with no mention of AI or ML capabilities.
Yes
The device is intended for supplemental fixation in conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor, all aimed at achieving fusion to alleviate symptoms or improve spinal stability. This falls under the definition of a therapeutic device.
No
The device description clearly states its purpose as a supplemental fixation device for spinal segments to support fusion, rather than for diagnosing conditions.
No
The device description explicitly states it consists of physical components (plates, rods, barrels) made of titanium alloy and PEEK polymer, which are hardware.
Based on the provided information, the SP-Fix™ Spinous Process Fixation Plate is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The SP-Fix™ is a physical implant designed to be surgically placed in the spine.
- The intended use describes a surgical procedure and the conditions it aims to treat. It does not involve testing or analyzing biological samples.
- The device description details the materials and components of a surgical implant. It does not mention reagents, calibrators, or other elements typically found in IVD devices.
The SP-Fix™ is a medical device used for surgical intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The SP-Fix™ Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix™ Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.
Product codes
KWP
Device Description
The SP-Fix™ Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix™ implants are composed of titanium alloy (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing (static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension) was conducted to demonstrate substantial equivalence to the predicate system(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) Summary: SP-Fix™ Spinous Process Fixation Plate
| Company: | Globus Medical Inc. | ||
|---|---|---|---|
| 2560 General Armistead Ave. | |||
| Audubon, PA 19403 | |||
| (610) 930-1800 | JAN 19 20 | ||
| Contact: | Kelly J. Baker, Ph.D | ||
| Director, Clinical Affairs & Regulatory |
Date Prepared: November 10, 2010
SP-Fix™ Spinous Process Fixation Plate Device Name:
- Classification: Regulation Number: 21 CFR §888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Product Code: KWP Regulatory Class II, Panel code 87.
- Medtronic Spire™ (K032037), LANX Aspen™ (K071877), Predicate(s): NuVasive AFFIX™ (K073278)
Purpose:
The purpose of this submission is the addition of the SP-Fix™ Spinous Process Fixation Plate to the REVERE® Stabilization System.
Device Description:
The SP-Fix™ Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. SP-Fix™ implants are composed of titanium alloy (per ASTM F136) and PEEK radiolucent polymer (per ASTM F2026).
Indications for Use:
The SP-Fix™ Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix™ Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.
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Performance Data:
Mechanical testing (static and dynamic compression, static torsion, static and dynamic plate dissociation, and static tension) was conducted to demonstrate substantial equivalence to the predicate system(s).
Basis of Substantial Equivalence:
The SP-Fix™ has been demonstrated to be substantially equivalent to predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device 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 lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 19 2011
Globus Medical, Inc. % Kelly J. Baker, Ph.D. Director, Clinical Affairs and Regulatory Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K102195
Trade Name: SP-Fix™ Spinous Process Fixation Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 30, 2010 Received: January 03, 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, 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.
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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.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,
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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Indications for Use Statement
510(k) Number: K102195 Device Name: SP-Fix™ Spinous Process Fixation Plate
INDICATIONS:
The SP-Fix™ Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The SP-Fix™ Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.
OR Prescription Use × (Per 21 CFR §801.109)
Over-The-Counter Use
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digit Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102195
Globus Medical K102195 SP-Fix™ CONFIDENTIAL