(27 days)
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of AI/ML components or data processing capabilities.
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, which is a therapeutic purpose.
No
The description explicitly states the device is intended to "provide immobilization and stabilization of spinal segments as an adjunct to fusion," as well as being a "pedicle screw fixation system." These are therapeutic, not diagnostic, functions.
No
The device description explicitly details physical components made of titanium alloy, Sulene-PET, and Sulene-PCU, which are hardware materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Dynesys Spinal System is a pedicle screw fixation system intended for surgical implantation to stabilize the spine. It is a physical implant used in the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Dynesys Spinal System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
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.
Product codes
NQP
Device Description
The Dynesys Spinal System is comprised of a variety pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws are manufactured from medical grade titanium alloy. The tensioning cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured from Sulene-PCU (polycarbonateurethane). The pedicle screws are provided with or without hydroxyapatite coating.
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)
Testing and analysis of proposed hydroxyapatite coated pedicle screw components for the Dynesys Spinal System was performed. The results of this testing demonstrated that the there are no fundamental technological differences between the proposed hydroxyapatite pedicle screws and the pedicle screw components of the current Dynesys Spinal System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dynesys® Spinal System (K031511, K043565)
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
Image /page/0/Picture/1 description: The image shows the logo for Zimmer Spine. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font, with a line underneath it. Below "zimmer", the word "spine" is written in a smaller, sans-serif font.
6 2006 APR
510(k) SUMMARY
| Submitter: | Zimmer Spine, Inc.
7375 Bush Lake Road
Minneapolis, MN 55439 |
|----------------------|----------------------------------------------------------------------------|
| Company Contact: | Tim Crabtree
Senior Regulatory Affairs Specialist |
| Date Prepared: | February 14, 2006 |
| Device Name: | Trade Name: Dynesys® Spinal System
Common Name: Spinal Fixation System. |
| Classification Name: | Posterior Metal/Polymer Spinal System, Fusion |
| Classification: | 21 CFR §888.3070, Pedicle screw spinal system |
| Class: | II |
| Product Code: | NQP |
| Predicate Devices: | Dynesys® Spinal System (K031511, K043565) |
Description of Device: The Dynesys Spinal System is comprised of a variety pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws are manufactured from medical grade titanium alloy. The tensioning cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured from Sulene-PCU (polycarbonateurethane). The pedicle screws are provided with or without hydroxyapatite coating.
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
1
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.
Comparison of Technological Characteristics:
Testing and analysis of proposed hydroxyapatite coated pedicle screw components for the Dynesys Spinal System was performed. The results of this testing demonstrated that the there are no fundamental technological differences between the proposed hydroxyapatite pedicle screws and the pedicle screw components of the current Dynesys Spinal System.
Substantial Equivalence:
The hydroxyapatite coated pedicle screws of Dynesys Spinal System are substantially equivalent to the original Dynesys Spinal System pedicle screw components based on intended use, design, and function.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
Zimmer Spine, Inc. c/o Mr. Tim Crabtree Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K060638
Trade/Device Name: Dynesys® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: NQP Dated: March 9, 2006 Received: March 10, 2006
Dear Mr. Crabtree:
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.
3
Page 2 - Mr. Tim Crabtree
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Helmut Lemke
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number: Pending K060638
Device Name: Dynesys® 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 (pseudarthrosis).
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.
Hulut lema a
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number Ko60638
Prescription Usc (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Usc (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dynesys® Spinal System HA Pedicle Screw Exhibit 16
Confidential
page 212
P.c.e c+