(71 days)
Dynesys® Spinal System, Medtronic Sofamor Danek CD HORIZON Spinal System
Not Found
No
The provided text describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes.
The device is used to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, which makes it a therapeutic device.
No
The device is an implant system used for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly states that the system consists of physical implants such as pedicle screws, set screws, spacers, and cords. It is a hardware-based spinal fixation system.
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 Dynesys Spinal System is a pedicle screw fixation system used to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical implant used in vivo (within the body) to treat structural issues.
- Device Description: The device description details the components of the system, which are implants like screws, spacers, and cords. These are physical devices implanted into the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments 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, and failed previous fusion (pseudoarthrosis),
In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:
- · Who are receiving fusions with autogenous graft only:
- · Who are having the device fixed or attached to the lumbar or sacral spine;
- · Who are having the device removed after the development of a solid fusion mass.
When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
Product codes (comma separated list FDA assigned to the subject device)
NQP
Device Description
The Zimmer® Dynesys® Spinal System, including the Dynesys Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers, and polyethylene terephthalate (PET) cords.
The Dynesys pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with ceramic hydroxyapatite (HA). The Dynesys Spinal System is also cleared for connection with the Zimmer DTO implant. The Zimmer DTO implant allows the connection of the Dynesys Spinal System to the Optima ZS Spinal System when the two systems are used on contiguous levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior use in the lumbar and sacral areas of the spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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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.
Dynesys® Spinal System, Medtronic Sofamor Danek CD HORIZON Spinal System
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
FEB. 8
Image /page/0/Picture/2 description: The image shows the logo for Zimmer Spine. The logo features a bold, stylized letter "Z" enclosed within a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and beneath that, the word "spine" is written in a smaller, less bold font.
510(k) SUMMARY Zimmer® Dynesys® Top-Loading Spinal System
510(k) Number
| Date of Summary Preparation: | November 28, 2007 |
|---|---|
| Submitter: | Zimmer Spine, Inc. |
| 7375 Bush Lake Road | |
| Minneapolis, MN 55439 | |
| Company Contact: | Elsa A. Linke |
| Senior Regulatory Affairs Specialist | |
| Manufacturer: | Zimmer GmbH |
| Sulzer Allee 8 | |
| CH-8404 Winterthur | |
| Switzerland | |
| Device Name: | Dynesys® Top-Loading Spinal System |
| Common Name: | Spinal Fixation System |
| Classification Name: | Posterior Metal/Polymer Spinal System, Fusion |
| Product Code: | NQP |
| Regulation Number: | 21 CFR 888.3070 |
| Device Classification: | Class II |
| Predicate Devices: | Dynesys® Spinal System |
| Medtronic Sofamor Danek CD HORIZON Spinal | |
| System |
Description of Device:
.
The Zimmer® Dynesys® Spinal System, including the Dynesys Top-Loading Spinal System, is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the lumbar and sacral areas of the spine. Implants of this system consist of fixed pedicle screws of varying diameters and lengths, set screws, polycarbonate urethane (PCU) spacers, and polyethylene terephthalate (PET) cords.
The Dynesys pedicle screw consists of a top-loading solid or cannulated shank, either uncoated or coated with ceramic hydroxyapatite (HA). The Dynesys Spinal System is also cleared for connection with the Zimmer DTO implant. The Zimmer DTO implant allows the connection of the Dynesys Spinal System to the Optima ZS Spinal System when the two systems are used on contiguous levels.
1
Intended Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments 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, and failed previous fusion (pseudoarthrosis),
In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:
- · Who are receiving fusions with autogenous graft only:
- · Who are having the device fixed or attached to the lumbar or sacral spine;
- · Who are having the device removed after the development of a solid fusion mass.
When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
Comparison of Technological Characteristics:
The Dynesys Top-Loading Spinal System shares the same technological characteristics as the predicate devices. These characteristics include similar design, materials, range of sizes, technical requirements, and intended use.
Substantial Equivalence:
The Dynesys Top-Loading Spinal System is substantially equivalent to the predicate devices in design, materials, function and intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB
FEB - 8 2008
Re: K073347
Zimmer Spine, Inc.
% Ms. Elsa A. Linke 7375 Bush Lake Road
Minneapolis, Minnesota 55439
Trade/Device Name: Zimmer® Dynesys® Top-Loading Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NQP Dated: November 28, 2007 Received: November 29, 2007
Dear Ms. Linke:
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 In microco in microadic devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls, provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's I'(