KOMPREDA

• K Number: K120597
• Device Name: KOMPREDA
• Manufacturer: CUSTOM SPINE, INC.
• Date Cleared: 2013-05-03 ( 430 days)
• Product Code: MRW
• Regulation Number: N/A
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K073515 , K012773
• Predicate For: N/A

Intended 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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KOMPRESA Facet Screw System:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed (ASTM Standard)	Acceptance Criteria (Implied)	Reported Device Performance
Axial pullout (F543-07)	Equivalent to predicate devices	Performed as per standard
Torque to failure (F543-07)	Equivalent to predicate devices	Performed as per standard
Static collet/locknut pull-off (F1798)	Equivalent to predicate devices	Performed as per standard
Dynamic collet/locknut pull-off (F1798)	Equivalent to predicate devices	Performed as per standard
Static three-point bend (F1264-03)	Equivalent to predicate devices	Performed as per standard
Dynamic cantilever bend (F1264-03)	Equivalent to predicate devices	Performed as per standard
Static cantilever bend (2193-02)	Equivalent to predicate devices	Performed as per standard

Note: The document explicitly states "Bench testing was performed to support the equivalence of the proposed facet screw system." This implies that the acceptance criteria for each test was that the performance of the KOMPRESA system should be substantially equivalent to its predicate devices (Trans 1 facet screw (K073515) and Depuy Spine's DISCOVERY facet screw system (K012773)). The document does not provide specific numerical thresholds for acceptance, only that the tests were performed "per" the listed ASTM standards to demonstrate equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text. For mechanical bench testing, sample sizes are typically determined by the relevant ASTM standard or risk analysis, but this information is absent.
• Data Provenance: The data is from bench testing, which is performed in a laboratory setting. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the clinical sense. The firm is located in Parsippany, NJ, USA, so the testing was presumably conducted there or at a testing facility within the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the provided document describes bench testing for a medical device (facet screw system), not an AI/PCSA system that requires expert ground truth for image analysis or diagnosis. The "ground truth" here is the physical measurement of mechanical properties according to established engineering standards.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth, not for mechanical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The document describes the mechanical testing of a surgical implant (facet screw system), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. This device is a physical surgical implant. There is no algorithm to evaluate in a standalone manner.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device's performance is established by engineering standards and physical measurements. The performance is compared against the known characteristics and performance data of the predicate devices. The material properties and design specifications are the core of the "ground truth" to which the device's physical performance is benchmarked for substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not an AI model. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

Summary

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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: [phone] Fax: [phone]

Official Correspondent

David Brumfield Senior VP of Research and Development, Quality, and Regulatory 9 Campus Dr. Parsippany, NJ 07054 Phone: [phone] Fax: [phone] E-mail: [e-mail]

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 [phone] or [phone] 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 [phone] or [phone] 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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Regulation Number and Section

N/A