(91 days)
Dynesys® Top-Loading Spinal System, K092234
No
The summary describes a mechanical spinal fixation system and its instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing, biocompatibility, and sterilization of the instruments.
Yes
The device is intended 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 Dynesys Spinal System is described as a temporary implant system used to correct spinal deformity and facilitate spinal fusion. Its intended use is for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly details physical implants (pedicle screws, set screws, spacers, cords) and instruments, with no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "pedicle screw fixation system" used for "immobilization and stabilization of spinal segments as an adjunct to fusion." This describes a surgical implant used within the body to treat structural issues.
- Device Description: The description details the components of the system, which are physical implants (screws, spacers, cords) designed to be surgically placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo (within the body) surgical implant.
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 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)
The Dynesys® Top-Loading Spinal System is substantially equivalent to the predicate devices in design, materials, function and intended use.
Since this submission focuses on the instruments, no performance testing was performed on the implants. The subject Dynesys® Top-Loading Spinal System instruments were reviewed and tested appropriately for design validation, biocompatibility and sterilization. The test results conclude the subject Dynesys® Top-Loading Spinal System to be substantially equivalent to the predicate device, Dynesys® Top-Loading Spinal System.
- Cadaver lab testing of the subject Dynesys® Top-Loading Spinal System to evaluate human factors regarding the combination of instrument design changes as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate device.
- Biocompatibility testing ensured the subject Dynesys® Top-Loading Spinal System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- Sterilization, Dry Time and Cleaning testing ensured the subject Dynesys® Top-Loading Spinal System steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices for the instruments.
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, K092234
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.
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
Image /page/0/Picture/1 description: The image shows the logo for Zimmer Spine. The logo features a stylized letter Z inside of a circle. Below the circle is the word "zimmer" in a stylized font, with the word "spine" underneath it in a smaller font.
510(k) SUMMARY
JAN 16 2014
Zimmer® Dynesys® Top-Loading Spinal System
Date of Summary Preparation:
Submitter:
Manufacturer (Implants):
Establishment Registration Number:
Manufacturer (Instruments):
Establishment Registration Number:
Company Contact (Primary):
Company Contact (Secondary):
Trade Name:
Device Name (Common Name):
Device Classification:
Product Code(s):
Regulation Number:
Regulation Description:
Predicate Devices:
January 16, 2014
Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439
Zimmer GmbH Sulzerallee 8 CH-8404 Winterthur Switzerland
9613350 (Zimmer GmbH)
Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439
2184052 (Zimmer Spine)
Michelle Lenz Regulatory Affairs Specialist Email: Michelle.Lenz@Zimmer.com Office: 952.830.6343 Fax: 952.837.6843
Jonathan Gilbert Regulatory Affairs Director Email: Jonathan. Gilbert@Zimmer.com Office: 952.830.6385 Fax: 952.837.6985
Dynesys® Top-Loading Spinal System
Spinal Fixation System
Class II
NQP
21 CFR § 888.3070
Posterior Metal/Polymer Spinal System, Fusion
Dynesys® Top-Loading Spinal System, K092234 cleared October 21, 2009
1
The purpose of this submission is to update the instrument labeling and to identify an alternative material vendor for a non-implanted component. This submission does not make any modifications to the subject dynamic stabilization device.
General 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 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.
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 Dynesvs Spinal System and the OPT/MA 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.
Summary of Technological Characteristics:
The subject Dynesys® Top-Loading Spinal System generally shares the same technological characteristics as its cleared predicate device, Dynesys® Top-Loading Spinal System, as described in K092234. The characteristics include the same general design, same materials, same range of sizes, same performance characteristics and the same intended use.
The subject and predicate Dynesys® Top-Loading Spinal System both consist of screws, cords, spacers and the instruments necessary to implant the spinal system. The implant components and materials are listed in the table below. The implants are provided sterile by gamma irradiation. The orthopedic surgical instruments are manufactured from Stainless Steel that meets ASTM A564.
2
| Device Description | Materials |
|---|---|
| Pedicle Screw | Protasul-100 (Titanium alloy (Ti-6Al-7Nb)) |
| Set Screw | Protasul-100 (Titanium alloy (Ti-6Al-7Nb)) |
| Pedicle Screw Coating | The top-loaded pedicle screw is offered in both coated and un-coated |
| versions. | |
| The coating used is Hydroxyapatite (HA). | |
| Cord | SULENETM-PET (polyethylene-terephthalate) |
| Plastic Spacers | Polycarbonate urethane (PCU) |
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 cleared for non-cervical posterior use in the thoracic, 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 subject Dynesys® Top-Loading pedicle screws consist of either a solid or cannulated shank, either uncoated or coated with hydroxyapatite (HA). The Dynesys® Spinal System was also cleared for connection with the Zimmer DTO™ implant in K071879. The Zimmer DTO™ implant allows the connection of the Dynesvs® Spinal System to the OPTIMA ZS Spinal System when the two systems are used on contiguous levels.
Summary of Performance Testing:
The Dynesys® Top-Loading Spinal System is substantially equivalent to the predicate devices in design, materials, function and intended use.
Since this submission focuses on the instruments, no performance testing was performed on the implants. The subject Dynesys® Top-Loading Spinal System instruments were reviewed and tested appropriately for design validation, biocompatibility and sterilization. The test results conclude the subject Dynesys® Top-Loading Spinal System to be substantially equivalent to the predicate device, Dynesys® Top-Loading Spinal System.
- Cadaver lab testing of the subject Dynesys® Top-Loading Spinal System to evaluate . human factors regarding the combination of instrument design changes as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate device.
- Biocompatibility testing ensured the subject Dynesys® Top-Loading Spinal System . materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- Sterilization, Dry Time and Cleaning testing ensured the subject Dynesys® Top-Loading . Spinal System steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices for the instruments.
Substantial Equivalence:
Zimmer Spine considers the subject Dynesys® Top-Loading Spinal System product performance to be substantially equivalent to the predicate device, Dynesys® Top-Loading Spinal System (K092234), because there are no changes to the product performance specifications or device functional scientific technology.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or birds in flight, stacked vertically.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2014
Zimmer Spine, Incorporated Ms. Michelle Lenz Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K133164
Trade/Device Name: Dynesys® Top-Loading Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: NQP Dated: September 30, 2013 Received: October 17, 2013
Dear Ms. Lenz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Michelle Lenz
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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
. I ..
K133164 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 OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Zane W. Watt -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133164