K Number
K062670
Device Name
VERTIFLEX SPINAL SCREW SYSTEM
Date Cleared
2007-01-12

(127 days)

Product Code
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When used as a posterior, noncervical pedicle screw system, the VertiFlex™ Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: - Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies; - Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; . - Degenerative spondylolisthesis; . - Trauma (i.e., fracture or dislocation); . - . Spinal stenosis; - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ● - Tumor: . - Pseudoarthrosis; and/or . - Failed previous fusion. .
Device Description
The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.
More Information

Not Found

No
The device description and performance studies focus on the mechanical properties and surgical implantation of the spinal screw system, with no mention of AI or ML capabilities.

Yes
The device is a spinal screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various acute and chronic instabilities of the thoracic, lumbar, and sacral spine, which aligns with the definition of a therapeutic device.

No

The device is described as a spinal screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.

No

The device description explicitly states it consists of physical components like pedicle screws and rigid connecting rods made of titanium alloy, which are hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Description and Intended Use: The VertiFlex™ Spinal Screw System is a surgical implant used to stabilize the spine. It is physically implanted into the patient's body and does not perform any tests on bodily samples.
  • Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, generating diagnostic results, or providing information about a patient's disease state based on laboratory testing.

Therefore, the VertiFlex™ Spinal Screw System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

When used as a posterior, noncervical pedicle screw system, the VertiFlex™ Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine:

  • Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
  • Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
  • Degenerative spondylolisthesis;
  • Trauma (i.e., fracture or dislocation);
  • Spinal stenosis;
  • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • Tumor;
  • Pseudoarthrosis; and/or
  • Failed previous fusion.

Product codes (comma separated list FDA assigned to the subject device)

MNH, MNI, NKB

Device Description

The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic, lumbar, and sacral spine

Indicated Patient Age Range

skeletally mature patients

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)

Non-clinical tests, including those conducted in accordance with such recognized standards as ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance.
No clinical testing was conducted to support this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K043232, K061520, K060979, K031175, K041925, K043343, K030625

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

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JAN 1 2 2007

Page 1 of 2
K062670

510(k) SUMMARY 5.0

In accordance with Title 21 Code of Federal Regulations (21 CFR), Part 807, and in particular, §807.92, the following 510(k) summary is provided for the VertiFlex™ Spinal Screw System:

5.1 Submitted By:

VertiFlex™, Incorporated 1954 Kellogg Avenue, Suite 100 Carlsbad, California 92008

Contact: Steve Reitzler, Vice President of Regulatory & Quality Assurance

Date Prepared: September 5, 2006

5.2 Device Name

Trade or Proprietary Name: VertiFlex™ Spinal Screw System Common or Usual Name: Pedicle Screw System Pedicle Screw Spinal System Classification Name: Classification Regulation: 21 CFR, §888.3070 Product Codes: MNH, MNI, NKB

5.3 Predicate Devices

The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate devices:

UCR Spinal System (Seaspine; K043232) VIPERTM Spine System (DePuy; K061520) Xia® Spinal System (Stryker; K060979) Click X® Svstem (Synthes: K031175) ST360TM Spinal Fixation System (Zimmer; K041925) CD HORIZON® Spinal System (Medtronic Sofamor Danek: K043343) PathFinder™ Spinal System (Spinal Concepts; K030625)

5.4 Device Description

The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimallyinvasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.

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Page 2 of 2 KO62670

5.5 Intended Use

The subject device is indicated for use as follows:

When used as a posterior, noncervical pedicle screw system, the VertiFlex™ Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine:

  • Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies:
  • Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
  • Degenerative spondylolisthesis; .
  • Trauma (i.e., fracture or dislocation); .
  • . Spinal stenosis;
  • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
  • Tumor: .
  • Pseudoarthrosis; and/or .
  • Failed previous fusion. .

5.6 Comparison to Predicate Devices

Testing and comparisons of design characteristics and features have established that the subject VertiFlex™ Spinal Screw System is substantially equivalent in design, materials of composition, indications, performance, and other features, to other predicate pedicle screw spinal systems commercially available in the U.S.

5.7 Summary of Non-Clinical Tests

Non-clinical tests, including those conducted in accordance with such recognized standards as ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance.

5.8 Summary of Clinical Tests

No clinical testing was conducted to support this submission.

5.9 Conclusions

The results of all testing and comparison demonstrated the substantial equivalence of the subject device to the identified predicate devices.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a double helix representing DNA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VertiFlex™, Incorporated % Mr. Steve Reitzler Vice President, Regulatory Affairs and Quality Assurance 1954 Kellogg Avenue, Suite 100 Carlsbad, California 92008

JAN 1 2 2007

Re: K062670

Trade/Device Name: VertiFlex™ Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, Dated: September 5, 2006 Received: September 7, 2006

Dear Mr. Reitzler:

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.

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Page 2 - Mr. Steve Reitzler

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 Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

Barbara Buehum

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Indications for Use

510(k) Number (if known): K062670

Device Name: VertiFlex™ Spinal Screw System

Indications for Use:

When used as a posterior, noncervical pedicle screw system, the VertiFlex™Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine:

  • Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
  • Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
  • Degenerative spondylolisthesis; .
  • Trauma (i.e., fracture or dislocation); .
  • . Spinal stenosis:
  • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
  • . Tumor;
  • Pseudoarthrosis; and/or .
  • Failed previous fusion.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K062670