(88 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The Dynesys® Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal instabilities or deformities, which is a therapeutic purpose.
No
This device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, rather than to diagnose medical conditions.
No
The device description clearly describes physical implants (cord-rod combination implant, pedicle screw) used in spinal surgery, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this is a "pedicle screw fixation system" intended for "immobilization and stabilization of spinal segments as an adjunct to fusion." This involves surgically implanting hardware into the body to treat structural issues in the spine.
- Lack of Mention of Biological Samples or Testing: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
Therefore, the Dynesys® Spinal System, as described, is a surgical implant and not an in vitro diagnostic device.
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 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 (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Dynesys 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 Dynesvs 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
NQP
Device Description
The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031511, K043565, K060638, K020279, K024096, K031585, K051971
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
510(k) Summary
| 510(k) Summary | OCT 5 2007
K071879
Image: Zimmer logo
zimmer
spine | |
|----------------------|--------------------------------------------------------------------------|--|
| Manufacturer: | Zimmer GmbH
Sulzer Allee 8
CH-8404
Winterthur, Switzerland | |
| Sponsor: | Zimmer Spine, Inc.
7375 Bush Lake Road
Minneapolis, MN 55439 | |
| Company Contact: | Nicole Bowden
Regulatory Affairs Associate | |
| Date Prepared: | July 2, 2007 | |
| Device Name: | Trade Name: Zimmer® DTO™ Implant | |
| Common Name: | Spinal Fixation System | |
| Classification Name: | Posterior Metal/Polymer Spinal System, Fusion (NQP), per 21 CFR 888.3070 | |
| Product Code: | NQP | |
| Predicate Devices: | Dynesys® Spinal System and OPTIMA™ ZS Spinal Fixation System | |
Description of Device:
The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.
1
Indications for Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization 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 (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Dynesys 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 Dynesvs 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.
Substantial Equivalence:
The Zimmer GmbH Zimmer DTO Implant is substantially equivalent to the Dynesys Spinal System (cleared in K031511, K043565 and K060638) and the OPTIMA ZS Spinal Fixation System (cleared in K020279, K024096, K031585 and K051971) in design, materials, function and intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
001 5 2007
Zimmer Spine, Inc. % Ms. Nicole Bowden 7375 Bush Lake Road Minneapolis, MN 55441
Re: K071879
Trade/Device Name: Zimmer® DTO™ Implant Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NQP Dated: July 2, 2007 Received: July 9. 2007
Dear Ms. Bowden:
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). 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 labeling:
The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section
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Page 2 - Nicole Bowden
510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Zimmer® DTO™ Implant
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 (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Dynesys 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, rodacord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
Prescription Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kaubare huchm
Division of General Restorative. and Neurological Devices
510(k) Number K071871