(22 days)
K99,460
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide temporary stabilization for a variety of spinal conditions, including degenerative disc disease, fractures, and deformities, with the goal of facilitating spinal fusion, which qualifies it as a therapeutic device.
No
The device is described as an Anterior Fixation System intended for screw/bolt fixation/attachment to intervertebral bodies to provide temporary stabilization until spinal fusion develops. It is a device for treatment and stabilization, not for diagnosis.
No
The device description explicitly states it consists of physical components like plates, bolts, screws, washers, and nuts, which are hardware.
No, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a surgical implant system (plates, bolts, screws, etc.) used for spinal fixation. Its intended use is to provide temporary stabilization of the spine during fusion.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information. It is a physical device implanted in the body for structural support.
Therefore, based on the provided information, the ZPLATE-ATL™ Anterior Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
-
- Pseudoarthrosis.
-
- Spondylolysis.
-
- Spondylolisthesis.
-
- Fracture.
-
- Neoplastic disease.
-
- Unsuccessful previous fusion surgery.
-
- Lordotic deformities of the spine.
-
- Idiopathic thoracolumbar or lumbar scoliosis
-
- Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
-
- Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MNH and KWP
Device Description
The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws, washers and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterolateral intervertebral bodies from T1 to L5
Indicated Patient Age Range
Not Found
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): 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.
K99,460
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
Z-PLATE ATL™ Anterior Spinal Fixation System 510(k) Summary April 26, 1999
Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proprietary Trade Name: ZPLATE-ATL™ Anterior Spinal Fixation System II.
III. Product Description
The ZPLATE-ATL™ Anterior Spinal Fixation System consists of a variety of shapes and sizes of plates, bolts, screws, washers and nuts, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.
Indications IV.
The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- Degenerative disc disease (as defined 1. by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
-
- Pseudoarthrosis.
-
- Spondylolysis.
- Spondylolisthesis. 4.
- న. Fracture.
- Neoplastic disease. 6.
- Unsuccessful previous fusion surgery. 7.
- Lordotic deformities of the spine. 8.
-
- Idiopathic thoracolumbar or lumbar scoliosis
-
- Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
-
- Neuromuscular deformity (i.e., scoliosis, fordosis, and / or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.
- V. Substantial Equivalence
Documentation was provided which demonstrated the ZPLATE-ATL™ Anterior Spinal Fixation System to be substantially equivalent to itself.
K99,460
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1999
Richard W. Treharne, Ph.D. Richard w. Trendino, and Regulatory Affairs Sofamor Danek 1800 Pyramid Place 38132 Memphis, Tennessee
K991364 Re: TENOR™ Spinal System Trade Name: K991460 ZPlate-ATL™ Anterior Fixation System Trade Name: Requlatory Class: II Product Codes: MNH and KWP April 19 and 26, 1999 Dated: April 20 and 27, 1999 Received:
Dear Dr. Treharne:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 aqainst misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does
2
Page 2 - Richard W. Treharne, Ph.D.
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celra M. Witten, Ph.D., M
Celia M. Witten, Bh.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
510(k) Number (if known):
Device Name: _ZPLATE-ATL™ Anterior Fixation System
Indications for Use:
The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from TI to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis. 2.
- Spondylolysis. 3.
- Spondylolisthesis. 4.
- રું. Fracture.
-
- Neoplastic disease.
- Unsuccessful previous fusion surgery. 7.
- Lordotic deformities of the spine. 8.
- Idiopathic thoracolumbar or lumbar 9. scoliosis
-
- Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
-
- Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 (Optional 1-2-96)
OR
Over-the-counter Use
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