(90 days)
The Zielke VDS Anterior Spine System.
Not Found
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to stabilize the spinal operative site during fusion procedures, provide immobilization, and assist in healing for various spinal conditions, which are all therapeutic functions.
No
The device is a spinal implant system intended for stabilization during fusion procedures, not for diagnosing conditions.
No
The device description clearly outlines various hardware components such as screws, hooks, rods, connectors, and instruments, which are physical implants and surgical tools. There is no mention of software as the primary or sole component of this medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples 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 Synergy™ Spinal System is a collection of implants (screws, hooks, rods, etc.) intended to be surgically implanted into the spine to provide stabilization during fusion procedures.
- Lack of Diagnostic Function: The device's purpose is mechanical support and stabilization, not the analysis of biological samples for diagnostic purposes.
The text describes a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Synergy™ Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the screws fixed or attached to the lumbar and sacral spine; (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium. In addition, the pedicle screw system may also be used 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are: 1 . Degenerative Disc Disease (as defined by discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Idiopathic scoliosis. 3. Kyphotic deformities of the spine. 4. Paralytic scoliosis and/or pelvic obliquity. 5. Lordotic deformities of the spine. 6. Neuromuscular scoliosis associated with pelvic obliquity. 7. Vertebral fracture or dislocation. 8. Tumors. 9. Spondylolisthesis. 10. Stenosis. 11. Pseudarthrosis. 12. Unsuccessful previous attempts at spinal fusion. For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy™ hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium. The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery. For anterior use, the recommended levels of attachment are: T10 - L3 for the double rod constructs and T5 - L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWQ and KWP
Device Description
The Synergy™ Spinal System components are grouped as follows: Posterior Application: 1. Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation. 2. Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws. 3. Adjustable and Fixed Transverse Connectors with Set Screws. 4. Closed and Axial Rod Connectors with Set Screws. 5. Lateral Connectors with Set Screws. 6. Rods. 7. Instruments. 8. Sterilizer case(s). Anterior Application: 1. Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws. 2. Vertebral Washers. 3. Fixed Transverse Connectors with Set Screws. 4. Rods. 5. Instruments. 6. Sterilizer case(s). NOTE: While the Variable Locking Screws and some fasteners (nut and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters. NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery. The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fifth lumbar-first sacral (L5-S1) vertebral joint; lumbar and sacral spine; thoracic, lumbar, and sacral spine; sacral/iliac; posterior thoracic and/or lumbar; T1 to the Sacrum/Ilium; T10 - L3; T5 - L5
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)
Data regarding the functional performance of the proposed Synergy™ Integral Screws has been generated. Testing included unilateral construct fatigue testing. The test data indicates that the proposed Synergy™ Integral Screws meet or exceed all functional requirements and support its suitability for use.
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.
The Zielke VDS Anterior Spine 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.
0
OCT 1 3 1999
510(k) SUMMARY
SUBMITTED BY
Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
(949) 453-3200
July 14, 1999
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Spinal Intervertebral Body Fixation Orthosis Common/Usual Name: Anterior Spine Implants Product Classification: Class II Proprietary Name: Synergy™ Integral Screws
PREDICATE DEVICE
The predicate device is the Zielke VDS Anterior Spine System.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
INDICATIONS-FOR-USE
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the screws fixed or attached to the lumbar and sacral spine; (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.
1
In addition, the pedicle screw system may also be used 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:
-
- Degenerative Disc Disease (as defined by discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
-
- Idiopathic scoliosis.
-
- Kyphotic deformities of the spine.
-
- Paralytic scoliosis and/or pelvic obliquity.
-
- Lordotic deformities of the spine.
-
- Neuromuscular scoliosis associated with pelvic obliquity.
-
- Vertebral fracture or dislocation.
-
- Tumors.
-
- Spondylolisthesis.
-
- Stenosis.
-
- Pseudarthrosis.
-
- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.
The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
- For anterior use, the recommended levels of attachment are: T10 L3 for the double rod constructs and T5 - L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
2
DEVICE DESCRIPTION
The Synergy™ Spinal System components are grouped as follows:
Posterior Application:
-
- Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
-
- Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws.
-
- Adjustable and Fixed Transverse Connectors with Set Screws.
-
- Closed and Axial Rod Connectors with Set Screws.
-
- Lateral Connectors with Set Screws.
-
- Rods.
-
- Instruments.
-
- Sterilizer case(s).
Anterior Application:
-
- Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
-
- Vertebral Washers.
-
- Fixed Transverse Connectors with Set Screws.
-
- Rods.
-
- Instruments.
-
- Sterilizer case(s).
NOTE: While the Variable Locking Screws and some fasteners (nut and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters.
NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.
COMPARISON TO THE PREDICATE DEVICE
The preamendment Zielke System and the Interpore Cross Synergy System are comparable anterior approach systems. Both are used to treat similar or the same conditions, have essentially the same precautions and contraindications for use, and have equivalent potential for complications for the risk of use. In addition, they all represent a
3
long standing, basic design concept and in terms of safety and effectiveness, differ only in minor details. Based on the basic design concept, the use of established well-known materials, feature comparisons, mechanical testing, indications for use, surgical approach, preproduction quality assurance planning and engineering analysis. Interpore Cross International believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed anterior spine system.
DISCUSSION OF NONCLINICAL TESTS
Data regarding the functional performance of the proposed Synergy™ Integral Screws has been generated. Testing included unilateral construct fatigue testing. The test data indicates that the proposed Synergy™ Integral Screws meet or exceed all functional requirements and support its suitability for use.
4
Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are stacked on top of each other, with "Public" and "Health" on the top line and "Service" on the bottom line. The text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 1999
Ms. Lynn M. Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
Re: K992369
Trade Name: Synergy™ Spinal System Regulatory Class: II Product Code: MNI, MNH, KWQ and KWP Dated: July 14, 1999 Received: July 15, 1999
Dear Ms. Rodarti:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/4/Picture/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle is blank. In the center of the circle is a symbol that looks like three faces in profile, stacked on top of each other.
5
Page 2 - Ms. Lynn Rodarti
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
510(k) Number (if known):
Synergy™ Integral Screws Device Name:
Indications-For-Use:
(PER 21 CFR 801.109)
The Synergy™ Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the screws fixed or attached to the lumbar and sacral spine: (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.
In addition, the pedicle screw system may also be used 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
(continued)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992369 |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR
Over-The-Counter Use(Optional Format 1-2-96)
7
510(k) Number (if known):
Synergy™ Integral Screws Device Name:
Indications-For-Use (cont'd):
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:
- 1 . Degenerative Disc Disease (as defined by discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
-
- Idiopathic scoliosis.
-
- Kyphotic deformities of the spine.
-
- Paralytic scoliosis and/or pelvic obliquity.
-
- Lordotic deformities of the spine.
-
- Neuromuscular scoliosis associated with pelvic obliquity.
-
- Vertebral fracture or dislocation.
-
- Tumors.
-
- Spondylolisthesis.
-
- Stenosis.
-
- Pseudarthrosis.
-
- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy™ hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium
The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: T10 - L3 for the double rod constructs and T5 - L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Bestorative Device
Division Sign-QII)
Division of General Restorative Devices K99236
510(k) Number