(204 days)
Xia Spinal System, Global Spinal Fixation System, Synergy Spine System
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of software, algorithms, or any technology related to AI/ML.
Yes
The device is described as a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions, which directly addresses a medical condition or ailment, defining it as a therapeutic device.
No
The device description clearly states its function is to provide "immobilization and stabilization of the spine as an adjunct to fusion," not to diagnose conditions.
No
The device description explicitly details physical components (pedicle screws, rods, locking cap screws, transverse linking mechanism) made of titanium, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pedicle screw system intended to provide immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues.
- Device Description: The description details physical components like screws, rods, and locking caps made of titanium. These are physical devices for surgical implantation, not reagents, instruments, or software used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to provide structural support.
N/A
Intended Use / Indications for Use
The Orthopedic Alliance Spine System is a pedicle screw system 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, spinal tumor and failed previous fusion (pseudarthrosis).
The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes
MNI
Device Description
The Orthopedic Alliance Spine System is a top-loading multiple component posterior spinal fixation system which consists of fixed and swivel-head pedicle screws, rods, locking cap screws, and a transverse linking mechanism. The screws are available in various lengths and diameters. The swivel-head pedicle screws are assembled at the factory to provide variable axis screw assemblies. The rods are 4mm in diameter and available in various lengths. The locking cap nuts are applied to the screws after the rods are placed to lock them into position. Cross linkage braces are also available to connect from one rod to another in bilateral constructs.
Materials: The devices are manufactured from CP Titanium and Ti6Al-4V ELI Titanium alloy per ASTM and ISO standards.
Function: The Orthopedic Alliance Spine System functions to provide immobilization and stabilization of the spine as an adjunct to fusion in the treatment of chronic instabilities or deformities of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine, L5-S1 vertebra (L3 to sacrum)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Xia Spinal System (Stryker Howmedica), Global Spinal Fixation System (U & I Corp.), Synergy Spine System (Interpore Cross)
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
Summary of Safety and Effectiveness
K033826
page 1 of 1
for the
Orthopedic Alliance Spine System
This safety and effectiveness summary for the Orthopedic Alliance Spine System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
1. Submitter :
Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562
Contact Person : Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562 Telephone: ( 909 ) 304-900 }
Date Prepared: December 2, 2003
| 2. Tradename: | Orthopedic Alliance Spine System |
|---|---|
| Common Name: | Spinal Fixation System |
| Classification Name: | Pedicle Screw Spinal System (888.3070) |
3. Predicate or legally marketed devices which are substantially equivalent :
- Xia Spinal System ( Stryker Howmedica ) .
- ◆ Global Spinal Fixation System ( U & I Corp.)
- Synergy Spine System ( Interpore Cross ) .
4. Description of the device :
The Orthopedic Alliance Spine System is a top-loading multiple component posterior spinal fixation system which consists of fixed and swivel-head pedicle screws, rods, locking cap screws, and a transverse linking mechanism. The screws are available in various lengths and diameters. The swivel-head pedicle screws are assembled at the factory to provide variable axis screw assemblies. The rods are 4mm in diameter and available in various lengths. The locking cap nuts are applied to the screws after the rods are placed to lock them into position. Cross linkage braces are also available to connect from one rod to another in bilateral constructs.
Materials: The devices are manufactured from CP Titanium and Ti6Al-4V ELI Titanium alloy per ASTM and ISO standards.
Function: The Orthopedic Alliance Spine System functions to provide immobilization and stabilization of the spine as an adjunct to fusion in the treatment of chronic instabilities or deformities of the spine.
5. Intended Use:
The Orthopedic Alliance Spine System is a pedicle screw system 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, spinal tumor and failed previous fusion ( pseudarthrosis ).
The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the Orthopedic Alliance Spine System and 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 and intended use.
JUL 0 1 2004
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle or other bird with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 01 2004
Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive, Suite A Marietta, California 92562
Re: K033826
Trade/Device Name: Orthopedic Alliance Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI Dated: May 1, 2004 Received: May 3, 2004
Dear Mr. Williams:
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.
2
Page 2 - Roger Williams
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/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
ad 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
3
Page 1 of 1
510(k) Number ( if known ): K033826
Device Name : Orthopedic Alliance Spine System
Indications For Use :
The Orthopedic Alliance Spine System is a pedicle screw system 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, spinal tumor and failed previous fusion ( pseudarthrosis ).
The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.
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 )
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________