(430 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant system and associated instruments, with no mention of AI/ML technology in the intended use, device description, or performance studies.
Yes.
The device is indicated for the treatment of various spinal conditions, including trauma, spondylolisthesis, and degenerative disc disease, which are therapeutic interventions.
No
The Kompresa Facet Screw System is a surgical implant used for facet fixation and stabilization, aiding fusion in the treatment of various spinal conditions. It does not perform diagnostic functions but is a therapeutic device.
No
The device description explicitly states it consists of physical components made from titanium alloy, stainless steel, and aluminum (screws, nuts, collets, instruments, guide wires). It also describes bench testing of these physical components.
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 the Kompresa Facet Screw System is for "bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion" for various spinal conditions. This is a surgical implant used in vivo (within the body) to treat structural issues.
- Device Description: The description details surgical screws, nuts, and collets made of titanium alloy, along with instruments and guide wires. These are all components of a surgical implant system.
- 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 treatment. The device itself is the treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 spinal levels: ·
- . Trauma, including spinal fractures and/or dislocation
- . Spondylolisthesis
- Spondylolysis ●
- . Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- . Degeneration of the facets with instability
Product codes
MR W
Device Description
The subject Kompresa Facet Screw System consist of non-sterile, single use cannulated screws of various diameters and lengths to be used in conjunction with different diameter nuts and a universal collet. The screws, nuts and collets are all made from titanium alloy Ti6Al4V. The Instruments and guide wires are made from various grades of stainless steel or aluminum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T10 to S1 spinal levels
Indicated Patient Age Range
Not Found
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)
Bench testing was performed to support the equivalence of the proposed facet screw system. Axial pullout, and torque to failure tests were performed per ASTM F543-07. Static and dynamic collet/locknut pull off-tests were performed per ASTM 1798. Static three-point bend and dynamic cantilever bend tests were performed per ASTM F1264-03. Static cantilever bend tests were performed per ASTM 2193-02.
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
Not Found
N/A
0
K120597
MAY 3 2013
Section VII. 510(K) SUMMARY
Date Prepared
May 1, 2013
Name of Firm
Custom Spine, Incorporated 9 Campus Dr. Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707
Official Correspondent
David Brumfield Senior VP of Research and Development, Quality, and Regulatory 9 Campus Dr. Parsippany, NJ 07054 Phone: (973) 265-5043 Fax: (973) 808-0707 E-mail: dbrumfield@customspine.com
Establishment Number 3005129649
Device Name
Legally Marketed Trade Name: KOMPRESA Facet Screw System Common Name: Facet Screw System Device Classification: Unclassified Reason unclassified: Pre-amendment Device Product Codes: MR W
Predicate Devices
Trans 1 facet screw (K073515), Depuy Spine's DISCOVERY facet screw system (K012773)
Device Description
The subject Kompresa Facet Screw System consist of non-sterile, single use cannulated screws of various diameters and lengths to be used in conjunction with different diameter nuts and a universal collet. The screws, nuts and collets are all made from titanium alloy
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Ti6Al4V. The Instruments and guide wires are made from various grades of stainless steel or aluminum.
Indications for Use
The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 spinal levels: ·
- . Trauma, including spinal fractures and/or dislocation
- . Spondylolisthesis
- Spondylolysis ●
- . Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- . Degeneration of the facets with instability
Materials
The screws, nuts and collets are made from titanium alloy Ti6AI4V. The instruments are made from various grades of stainless steel or aluminum.
Performance Data
Bench testing was performed to support the equivalence of the proposed facet screw system. Axial pullout, and torque to failure tests were performed per ASTM F543-07. Static and dynamic collet/locknut pull off-tests were performed per ASTM 1798. Static three-point bend and dynamic cantilever bend tests were performed per ASTM F1264-03. Static cantilever bend tests were performed per ASTM 2193-02.
Substantial Equivalence Statement
Documentation is provided to demonstrate that the Kompresa Facet Screw System is substantially equivalent to its predicate devices in terms of its material. design. indications for use, and performance characteristics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Custom Spine, Incorporated % Mr. David L. Brumfield 9 Campus Drive Parsippany, New Jersey 07054
Re: K120597
Trade/Device Name: KOMPRESA Facet Screw System Regulatory Class: Unclassified Product Code: MR W Dated: April 19, 2013 Received: April 24, 2013
Dear Mr. Brumfield:
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 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.
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Page 2 - Mr. David L. Brumfield
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Meith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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Section VI. INDICATIONS FOR USE STATEMENT
510(k) Number : _ K120597
The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 (included) spinal levels:
- Trauma, including spinal fractures and/or dislocation .
- Spondylolisthesis .
- Spondylolysis .
- Pseudoarthrosis or failed previous fusions which are symptomatic or which may � cause secondary instability or deformity
- Degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies).
- Degeneration of the facets with instability .
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off)
Division of Orthopedic Devices
510(k) Number: K120597
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