(296 days)
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 neurological impairment, kyphosis, 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; a)
- b) Who are having the device fixed or attached to the lumbar or sacral spine; and
- c) Who are having the device removed after the development of a solid fusion mass.
The DYNESYS® Spinal System consists of four pedicle screws, two cords and two spacers in a symmetric, bilateral arrangement. The pedicle screws are placed lateral to the facet joints with two screws in the cephalad position and two screws in the caudad position. The superior-inferior distance between the pedicle screws is maintained with the spacers. The cord passes through the eye of the pedicle screw heads and through the centers of the spacers.
This document is a 510(k) Pre-Market Notification for the DYNESYS® Spinal System. It is an application for regulatory clearance, claiming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance. Therefore, most of the requested information cannot be extracted from this document.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria or report performance metrics from a study designed to meet such criteria. It states that "Establishment of equivalence is based on similarities of intended use, design, and performance characteristics" to the predicate device.
2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document does not describe a clinical study with a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This document does not describe a clinical study with adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document is for a medical device (spinal system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a medical device (spinal system), not for an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. This document does not discuss a clinical study with ground truth. The basis for clearance is substantial equivalence to a predicate device.
8. The sample size for the training set:
Not applicable. This document describes a medical device, not a machine learning model that would have a training set.
9. How the ground truth for the training set was established:
Not applicable. This document describes a medical device, not a machine learning model.
Additional relevant information from the document:
- Device Name: DYNESYS® Spinal System
- 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 neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis)."
- Predicate Device: Silhouette™ Spinal Fixation System (K980288)
- FDA Limitation: The FDA added a limitation to the labeling: "The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established." This indicates that while the device was found substantially equivalent for specified uses, potential broader uses were explicitly excluded without further proof.
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Centerpulse Spine-Tech, Inc. (d/b/a Zimmer Spine)
510(k) Summary (21 CFR Part 807.92)
Submitter Information A.
| Submitter's Name: | Tim Crabtree |
|---|---|
| Address: | 7375 Bush Lake RoadMinneapolis, MN 55439-2027 |
| Telephone Number: | (952) 857-5631 |
| Fax Number: | (952) 832-5931 |
| Contact Person: | Tim Crabtree |
| Date Submission Prepared: | May 13, 2003 |
| B.Device Information | |
| Trade Name: | DYNESYS® Spinal System |
| Common or Usual Name: | rod, hook, and screw spinal instrumentation |
| Classification Name: | (per 21 CFR Part 888.3070) |
| Device Classification: | Class II (per 21 CFR Part 888.3070)Panel -Orthopedic |
| Predicate Device: | Silhouette™ Spinal Fixation System(K980288) |
Subject Device Description:
The DYNESYS® Spinal System consists of four pedicle screws, two cords and two spacers in a symmetric, bilateral arrangement. The pedicle screws are placed lateral to the facet joints with two screws in the cephalad position and two screws in the caudad position. The superior-inferior distance between the pedicle screws is maintained with the spacers. The cord passes through the eye of the pedicle screw heads and through the centers of the spacers.
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
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KC3150 p²/₂
chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, 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; a)
- b) Who are having the device fixed or attached to the lumbar or sacral spine; and
- c) Who are having the device removed after the development of a solid fusion mass.
C. Substantial Equivalence
The technological characteristics of the DYNESYS® Spinal System are similar to the following commercially available devices:
- Silhouette™ Spinal Fixation System (K980288), manufactured by . Centerpulse Spine-Tech, Inc. and cleared by the FDA on July 29, 1998.
Establishment of equivalence is based on similarities of intended use, design, and performance characteristics.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Mr. Tim Crabtree Senior Regulatory Affairs Specialist Centerpulse Spine-Tech, Inc. 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027
Re: K031511
Trade/Device Name: Dynesys® Spinal System Regulatory Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NQP Dated: January 26, 2004 Received: January 28, 2004
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). 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 Scction 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 - Mr. Tim Crabtree
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 av results in this letter will allow you to begin marketing your device as described in your Section 110(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 or any I 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 (301) 594-4639. 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 its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David C. Sabatini, MD
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications Enclosure 12.0
| 510(k) Number (if known): | K031571 |
|---|---|
| --------------------------- | --------- |
Device Name: _________________________________________________________________________________________________________________________________________________________________
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, kyphosis, 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:
- a) Who are receiving fusions with autogenous graft only
- b) Who are having the device fixed or attached to the lumbar or sacral spine; and
- c) Who are having the device removed after the development of a solid fusion mass.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number |
Page 1 of 1
§ 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.