(288 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "spinal fixation system" intended to "stabilize and promote spinal fusion" for various medical conditions like spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion. These functions align with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No.
The device is described as a "spinal fixation system" intended to "stabilize and promote spinal fusion" for various spinal conditions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a multiple component, posterior spinal fixation system consisting of physical components like pedicle screws, rods, set screws, connectors, hooks, and a transverse linking mechanism. This indicates it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Vertefix® Pedicle Screw Spinal System Function: The description clearly states that the Vertefix® system is a "multiple component, posterior spinal fixation system" intended for "posterior, non cervical pedicle fixation" to "stabilize and promote spinal fusion." This is a surgical implant used directly within the body to provide structural support.
- Lack of Specimen Examination: The device description and intended use do not involve the examination of any biological specimens outside of the body.
Therefore, based on the provided information, the Vertefix® Pedicle Screw Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scollosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Removal of the implants after the attainment of a solid fusion is optional.
Product codes
MNI, MNH, KWP
Device Description
The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism.
The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine, non-cervical
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)
The Vertefix® Pedicle Screw Spinal System components were biomechanically tested in accordance with ASTM F1717. This testing demonstrated substantial equivalence to the predicate systems and other marketed systems.
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
§ 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.
0
AUG 3 0 2007
SECTION 4 - 510(k) SUMMARY
[As required by 21CFR807.92]
Image /page/0/Picture/5 description: The image shows a document with several lines of text. The text appears to be written in a dark ink, and the document is likely a printed or handwritten page. The text is partially obscured by black bars, which cover portions of the lines. The document seems to be a formal or official paper, possibly a letter or a legal document.
ELITE SURGICAL SUPPLIES (PTY) LTD
P.O. Box 26115 Arcadia Pretoria 0007 South Africa
Contact Person: John O'Toole Contact Title: Managing Director Tel: +27 12 386 0012 Fax: +27 12 386 2745 Email: john@elitesurgical.com
Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System
Page 4-1
1
4.1 Date Prepared [21CFR807.92(a)(1)]
October 4, 2006
4.2 Submitter's Information [21CFR807.92(a)(1)]
| Company
| Name: | Elite Surgical US |
|---|---|
| Street Address: | 503 Commerce Park Drive, Suite I |
| City: | Marietta |
| State/Province: | Georgia |
| Country: | USA |
| Telephone: | 404-408-2396 |
| Facsimile: | 770-590-5152 |
| Contact | Charise de Barros |
| Contact Title: | Agent |
| Contact Email: | Charise@EliteSurgicalUSA.com |
4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]
| Trade Name: | Vertefix® Pedicle Screw Spinal
System |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Pedicle Screw Spinal Fixation
System |
| Classification Name: | Spinal Pedicle Screw
Fixation Orthosis(MNI)
per 21 CFR § 888.3070
Spondylolisthesis Spinal
Fixation Orthosis (MNH)
per 21 CFR § 888.3070
Spinal Interlaminal
Fixation Orthosis (KWP)
Per 21 CFR § 888.3050 |
| Device Class: | Class II |
| Product Code: | MNI, MNH, KWP |
man and the state
2
4.4 Identification of Predicate Device(s) [21CFR807.92(a)(3)]
| PREDICATE DEVICES | |
|---|---|
| U and I Corporation, OPTIMA™ Spinal System | |
| MNI, MNH, KWQ | |
| (K051971) | |
| K2M Inc, Denali™ Spine System | |
| KWP, MNH, MNI | |
| (K042635) | |
| Howmedica Osteonics Corp. XIA™ Spine System Hooks | |
| MNH | |
| (K001319) |
There are no significant differences between the Vertefix® Pedicle Screw Spinal System and the OPTIMA™ System, the Denali146 Spine System, the XIATM Spine System Hooks, or other spinal fixation systems currently being marketed, which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials, operational principles and intended use.
4.5 Description of the Device [21CFR807.92(a)(4)]
The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism.
The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.
4.6 Intended Use [21CFR807.92(a)(5)]
The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scollosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Removal of the implants after the attainment of a solid fusion is optional.
3
4.7 Technological Characteristics [21CFR807.92(a)(6)]
The Vertefix® Pedicle Screw Spinal System components were biomechanically tested in accordance with ASTM F1717. This testing demonstrated substantial equivalence to the predicate systems and other marketed systems. Further comparison to the predicates also demonstrated substantial equivalence in terms of intended use. operating principle. materials, shelf life and design. There are no significant differences between the Vertefix® spinal system, and other systems currently marketed which would adversely affect the use of the product. The Vertefix® Spinal System components are fabricated from titanium alloy (Ti-6Al-4v ELI) that conforms to ASTM F 136. Various sizes of these implants are available for the application.
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2007
Elite Surgical Supplies (Pty) Ltd. % Ms. Charise De Barros Agent 503 Commerce Park Drive SE, Suite i Marietta, GA 30060
Re: K063453 Trade/Device Name: VERTEFIX® Pedicle Screw Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: August 6, 2007 Received: August 9, 2007
Dear Ms. De Barros:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Ms. Charise De Barros
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chabane Buelun
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 3 - INDICATIONS FOR USE
Elite Surgical Supplies (Pty) Ltd Applicant K063453 510(k) Number (if known) Vertefix® Pedicle Screw Spinal System Device Name
Indications for Use: The Vertefix® Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients receiving fusion by non-ber nour pealers in the thoracolumbar spine, for the following indications:
- Spondylolisthesis; �
- Trauma (e.g. fracture or dislocation); 参
- Spinal stenosis; 载
- Deformities or curvatures (scoliosis, kyphosis and lordosis); .
- Tumor:
- Pseudoarthrosis; and
- Failed previous fusion.
OR Over-the-Counter Use_ Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harbare Buclus
Division of General, Restorative, and Neurological Devices
510(k)Number K063453
dicle Screw Spinal System
Page 3-1