(55 days)
Not Found
No
The summary describes a mechanical spinal fixation system made of titanium alloy, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is intended to treat specific medical conditions, such as severe spondylolisthesis, fractures, and deformities of the spine, by providing immobilization and stabilization to aid in fusion.
No
The device is described as a spinal fixation system intended to provide immobilization and stabilization for fusion, not to diagnose medical conditions.
No
The device description explicitly states that the system includes screws, rods, connectors, and transverse connectors, all manufactured from Titanium Alloy. These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fixation and stabilization during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details screws, rods, connectors, and transverse connectors made of titanium alloy. These are physical implants, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing diagnostic information.
The device is a spinal fixation system, which falls under the category of medical devices used for surgical intervention and support.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).
Product codes
MNI, MNH
Device Description
The Spine Next SHIRAZ JAVA Top Loading Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with the bone graft. These implanted are intended to be removed after development of a solid fusion mass. The system includes screws, rods, connectors and transverse connectors.
All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fifth lumbar - first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 to sacrum), 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
Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798
Key Metrics
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
JAN 2 7 2004
K033772
PI=t2
510(k) Summary)
SUBMITTED BY
Diane Johnson On Behalf of Spine Next America Jackson Building, Suite 110 8381 Dix Ellis Trail Jacksonville, FL 32256
Date Submitted: December 1, 2003
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Trade/Proprietary Name: | Spine Next SHIRAZ JAVA Spinal Fixation
System |
|-------------------------|----------------------------------------------------------------------------------|
| Common/Usual Name: | Pedicle Screw Fixation System |
| Classification Names: | Orthosis, Spondylolisthesis Spinal Fixation
Orthosis, Spinal Pedicle Fixation |
PREDICATE DEVICE
Moss Miami [K021880, cleared June 26, 2002]. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92
DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION
The Spine Next SHIRAZ JAVA Top Loading Spinal Fixation System is designed to aid the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with the bone graft. These implanted are intended to be removed after development of a solid fusion mass. The system includes screws, rods, connectors and transverse connectors.
All implants are manufactured from Titanium Alloy (Ti6A4V) meeting the requirements of ASTM F136.
INDICATIONS FOR USE
When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is also intended to provide immobilization and stabilization of spinal segments in
1
14- (5) 3 3 2 2
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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
PERFORMANCE DATA
Biomechanical testing, including static and dynamic testing, was performed in accordance with ASTM F1717 and ASTM 1798
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2004
Ms. Diane Johnson Spine Next America Director, Regulatory Affairs 104 Greenwood Creek Road Queenstown, MD 21658
Re: K033772
Trade Name: Spine Next SHIRAZ JAVA Spinal Fixation System -- Addition of Transverse Connector Regulation Number: 21 CFR 888.3070 (b) (1), 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: MNI, MNH Dated: December 1, 2003 Received: December 3, 2003
Dear Ms. Johnson:
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 (Spccial 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.
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Page 2 - Ms. Diane Johnson
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. 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.
Sincerely vours.
Mark A. Millhuser
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ 长 ○ 3 3 7 コ 1
Device Name: Spine Next SHIRAZ JAVA Spinal Fixation System
Indications for Use:
When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a pedicle screw fixation system, the SHIRAZ JAVA Spinal Fixation System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(PER 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Format 1-2-96
Mark A. Millman