(91 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fusion system and does not mention any AI or ML components or capabilities.
No
A therapeutic device is one that treats a disease or condition. This device is used to immobilize and stabilize the spine as an adjunct to fusion, which facilitates healing or improved function, but it does not directly treat a disease.
No
The device is a fusion system intended for immobilization and stabilization of the spine, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists hardware components such as screws, washers, rods, set screws, and locking nuts, indicating it is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Spartek™ System Function: The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a surgical implant used to stabilize the spine. It is physically implanted into the patient's body and does not analyze biological specimens.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test performed on samples.
Therefore, based on the provided information, the Spartek™ system falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous bone graft for the following indications: degenerative disc disease (DDD) (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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Product codes
NKB, MNH, MNI
Device Description
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for monoand multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
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)
Testing performed indicates the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is substantially equivalent to predicate devices as demonstrated through static compression bending, static torsion, and dynamic compression bending as described in ASTM F1717, and other special controls.
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
K103383
FEB 17 2011
5. 510(k) Summary
| Contact: | Henry Klyce
President, CEO
Spartek Medical, Inc. |
|--------------------|-----------------------------------------------------------------------------------|
| Date Prepared: | November 16, 2010 |
| Device Trade Name: | Spartek™ Variable Angle Pedicle Screw Posterior Fusion System |
| Manufacturer: | Spartek Medical, Inc.
1100 Marina Village Pkwy, Suite 103
Alameda, CA 94501 |
| Common Name: | Pedicle screw spinal system |
| Classification: | 21 CFR §888.3070, Class III |
| Product Codes: | NKB, MNH, MNI |
Indications For Use:
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous bone graft for the following indications: degenerative disc disease (DDD) (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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Description:
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for monoand multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
Predicate Device(s):
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System was shown to be substantially equivalent to the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System, K094402, having the same indications for use, design, materials, and performance specifications.
Performance Standards:
Testing performed indicates the Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is substantially equivalent to predicate devices as demonstrated through static compression bending, static torsion, and dynamic compression bending as described in ASTM F1717, and other special controls.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring three stylized, overlapping shapes that resemble an abstract bird or a series of waves. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 7 2011
Spartek Medical, Inc. % Mr. Henry Klyce President. CEO 1100 Marina Village Parkway, Suite 103 Alameda. California 94501
Re: K103383
Trade/Device Name: Spartek" Variable Angle Pedicle Screw Posterior Fusion System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: January 24, 2011 Received: February 04, 2011
Dear Mr. Klyce:
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
2
Page 2 – Mr. Henry Klyce
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/ReportalProblem/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 vours.
Aty B. R. for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. Indications for Use
510(k) Number (if known):
Device Name: Spartek™ Variable Angle Posterior Fusion System
The SpartekTM Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (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); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
|----------------------------------------------------------------|--------|------------------------------------------------|
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE) | | |
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aontik for RPJ
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number j