(70 days)
Dynesys® Top-Loading Spinal System, Zimmer Spine ST3600® Spinal System, TiTLE® 2 Polyaxial Screw System
Not Found
No
The device description focuses on mechanical components for spinal fixation and fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is a temporary implant system used to correct spinal deformity and facilitate spinal fusion, which are therapeutic actions to treat medical conditions.
No
The Dynesys Spinal System is described as a "temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion," indicating it is a treatment device, not a diagnostic one. Its intended use focuses on providing immobilization for spinal segments as an adjunct to fusion for various instabilities or deformities.
No
The device description explicitly states that the system consists of physical implants such as pedicle screws, set screws, spacers, and cords. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant system used to provide immobilization and facilitate spinal fusion in skeletally mature patients with specific spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details the components of a spinal implant system (screws, spacers, cords). These are physical implants used within the body, not reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
The device is a surgical implant system used for treatment, not for diagnosing a condition.
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 OPT/MA 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
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): 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® Top-Loading Spinal System, Zimmer Spine ST3600® Spinal System, TiTLE® 2 Polyaxial Screw 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.
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Image /page/0/Picture/11 description: The image shows the Zimmer Spine logo. The logo consists of a stylized letter Z inside a circle, with the word "zimmer" written in a sans-serif font below it. The word "spine" is written in a smaller font below "zimmer". The logo is black and white.
510(k) SUMMARY Zimmer® Dynesys® Top-Loading Spinal System
KO92234 510(k) Number
OCT 21 2009
| OCT 21 2009 | |
|---|---|
| Date of Summary Preparation: | July 22, 2009 |
| Submitter: | Zimmer Spine, Inc. |
| 7375 Bush Lake Road | |
| Minneapolis, MN 55439 | |
| Company Contact: | Elsa A. Linke |
| Regulatory Affairs | |
| Manufacturer: | Zimmer GmbH |
| Sulzerallee 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® Top-Loading Spinal System |
| Zimmer Spine ST3600® Spinal System | |
| TiTLE® 2 Polyaxial Screw 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.
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1
Intended Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesvs 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 spondy|olisthesis 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.
Image /page/1/Figure/12 description: The image is mostly white with some black spots scattered throughout. The spots are concentrated in the upper left and lower left corners, with a few scattered in the middle. The spots are small and irregular in shape.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer Spine % Ms. Elsa A. Linke Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027
OCT 2 1 2009
Re: K092234
Trade/Device Name: Dynesys® Top-Loading Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: NOP Dated: July 22, 2009 Received: July 23, 2009
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 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 Warning section of the device's labeling:
"The safety and effectiveness of this device has not been established for the intended use of spinal stabilization without fusion. This device is only intended to be used when fusion with bone graft is being performed at all instrumented levels. "
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.
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Page 2- Ms. Elsa A. Linke
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 procced to the market. This letter will allow you to begin marketing your device as described in your Section 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information.regardingstherse.exentsy-please.go.to ---------------------------------------------------------------------------------------------------------------------------http://www.fda.gov/cdrh/mdr/.
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Page 3- Ms. Elsa A. Linke
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Christy Foreman for
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: Dynesys® Top-Loading Spinal System
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 OPT/MA ZS Transition Screw. The indications for use for each level is as specified for each system.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| 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)
 Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number_ KO92234
Dynesys Top-Loading Spinal System Line Extension 510(k) Submission
CONFIDENTIAL