(153 days)
Not Found
No
The device description focuses on mechanical components (screws, rods, connectors, hooks) and their physical properties and intended use in spinal fusion. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an aid to fusion, which directly treats medical conditions such as instabilities or deformities of the spine.
No
The device description clearly states that the ART Posterior Spinal System is a pedicle screw system intended for immobilization and stabilization of spinal segments, acting as an adjunct to fusion. This indicates a therapeutic or surgical function rather than a diagnostic one. No mention of diagnosis or diagnostic capabilities is made in the provided text.
No
The device description clearly details physical components such as pedicle screws, rods, connectors, and hooks, which are hardware implants.
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 detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the ART Posterior Spinal System is a pedicle screw system intended for surgical implantation to provide immobilization and stabilization of spinal segments. It is a physical implant used within the body, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such analysis.
Therefore, the ART Posterior Spinal System is a surgical implant/device and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as a n adjurce 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system ART Posterior Spinal System is indicated 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.
The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP
Device Description
Pedicle Screws, monoaxial and polyaxial, are available in various lengths and diameters. The Screw is connected to Federe Screws, nonoaxian and polyamin, are a in lengths ranging from 40mm to 500mm. The Screw is inserted the Rod Via a Not Connector and inserted in the bone. As a top loading system the Connector has a Uthrough an opening the Rod. The interior of the U-shaped opening in the Connector is threaded to accept a Shaped Opening that accepts the Rod. The Connector. The necessity for rod bending is reduced by the ability to vary the angle between the screw and connector up to 20°.
A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.
A Cross Connector, of varying lengths, attaches to the rods to provide rotational stability to the construct.
Pedicle, laminar and transverse hooks are also part of the system. The rods attach to the hooks and can be used for single or multiple level fixations.
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, noncervical spine, T1-S1 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 was performed according to ASTM F1717.
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.
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.
0
510(k) Summary
Date
September 29, 2003
MAR - 1 2004
Submitter
Advanced Medical Technologies AG Kasteler Strasse 11 66620 Nonnweiler-Braunshausen Germany
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name
Posterior spinal system
Classification name
Spondylolisthesis spinal fixation device system 888.3070 Pedicle screw spinal system 888.3070 Spinal interlaminal fixation orthosis 888.3050
Equivalent Device
Equivalent Device
The ART Posterior System is similar in design, material and indications as the ISOBAR Pedicle Screw System (Scient'x, K990118 and K013444).
Device Description
Device Describution
Pedicle Screws, monoaxial and polyaxial, are available in various lengths and diameters. The Screw is connected to Federe Screws, nonoaxian and polyamin, are a in lengths ranging from 40mm to 500mm. The Screw is inserted the Rod Via a Not Connector and inserted in the bone. As a top loading system the Connector has a Uthrough an opening the Rod. The interior of the U-shaped opening in the Connector is threaded to accept a Shaped Opening that accepts the Rod. The Connector. The necessity for rod bending is reduced by the ability to vary the angle between the screw and connector up to 20°.
A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.
A Cross Connector, of varying lengths, attaches to the rods to provide rotational stability to the construct.
Pedicle, laminar and transverse hooks are also part of the system. The rods attach to the hooks and can be used for single or multiple level fixations.
Intended Use
Intended USE
The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization of The ART I oseror in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and spiners signients in skelemities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with chionic insabilities of detorinates of the moration, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system ART Posterior Spinal System is indicated 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 (Uraces J and 4) of the 155 UT verseau in disacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacraViliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.
Summary Nonclinical Tests
Testing was performed according to ASTM F1717.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Advanced Medical Technologies AG C/o Mr. J.D.Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K033150
Trade/Device Name: ART Posterior Spinal System Regulatory Number: 21 CFR 888.3070, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: February 14, 2004 Received: February 23, 2004
Dear Mr. Webb:
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 - Mr. J.D.Webb
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) 594-4639. 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
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
510(k) number (if known): _ | (0 3 })50
evice Name: AR
Device Name:
Indications for Use:
ART Posterior Spinal System Indications for Use
The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as a n adjurce 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system ART Posterior Spinal System is indicated 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.
The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.
(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) _
ﻤﺴﺎ
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number Division of General, Restorative. and Neurological Devices
510(k) Number_K033/50
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