(90 days)
Not Found
Not Found
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "a temporary construct that assists normal healing" and "intended to stabilize the spinal operative site during fusion procedures," which are therapeutic functions. It is used to treat various spinal conditions, further supporting its therapeutic nature.
No
The device is a spinal implant system used for stabilization during fusion procedures, not for identifying or assessing a disease or condition.
No
The device description explicitly lists numerous hardware components including screws, hooks, rods, connectors, instruments, and sterilizer cases, indicating it is a physical implant system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Synergy™ Spinal System is described as a temporary construct intended to stabilize the spinal operative site during fusion procedures. It consists of implants (screws, hooks, rods, etc.) that are physically attached to the spine. Its intended use is for surgical procedures to treat various spinal conditions.
The device's function is mechanical stabilization within the body, not the analysis of biological samples outside the body.
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 spinc; (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 houk 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 hitory and radiographic studies).
-
- Idiopathic scoliosis.
-
- Kyphotic deformities of the spine.
-
- Paralytic scoliosis and/or pelvic obliquity.
-
- Lordotic deformities of the spinc.
-
- 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/Hium.
For anterior use, the recommended levels of attachment are: 110 - 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
KWQ, KWP, MNH, MNI
Device Description
The Synergy Spinal System components are grouped as follows:
Posterior Application:
-
- Integrai 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 Sct 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, lumbar and sacral spine (L3 to S1/Ilium), thoracic, lumbar, and sacral spine, posterior thoracic and/or lumbar, sacral/iliac, T1 to the Sacrum/Hium. Anterior: 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 D2 Spinal Implants has been generated. Testing included unilateral construct fatiguc testing in axial compression. The data indicates that the proposed Synergy D2 Spinal Implants meet or exceed all functional requirements and support their suitability for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Interpore Cross International Synergy Interior and Posterior, Stainless Steel and Titanium Spinal Systems.
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
3/23/99
K984578
510(k) SUMMARY
SUBMITTED BY
Lynn Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
(949) 453-3200
Date Submitted: December 22, 1998
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis
Appliance, Fixation, Spinal Interlaminal
Spondylolisthesis Spinal Fixation Device System |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Anterior and Posterior Spine Implants, Universal Spine System |
| Product Classification: | Class II |
| Proprietary Name: | Synergy™ D2 Spinal Implants |
PREDICATE DEVICE
The predicate device is the Interpore Cross International Synergy Interior and Posterior, Stainless Steel and Titanium Spinal Systems.
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.
1
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 spinc; (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 houk 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 hitory and radiographic studies).
-
- Idiopathic scoliosis.
-
- Kyphotic deformities of the spine.
-
- Paralytic scoliosis and/or pelvic obliquity.
-
- Lordotic deformities of the spinc.
-
- 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/Hium.
For anterior use, the recommended levels of attachment are: 110 - 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.
DEVICE DESCRIPTION
The Synergy Spinal System components are grouped as follows:
2
Posterior Application:
-
- Integrai™ 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 Sct 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.
COMPARISON TO THE PREDICATE DEVICE
The Interpore Cross Syncrgy D2 Spinal Implants are technologically substantially equivalent to the predicate devices based on the basic design concept, the use of cstablished well-lonown materials, feature comparisons, mechanical testing, indications for use, surgical approach, preproduction quality assurance planning and engineering analysis.
DISCUSSION OF NONCLINICAL TESTS
Data regarding the functional performance of the proposed Synergy D2 Spinal Implants has been generated. Testing included unilateral construct fatiguc testing in axial compression. The data indicates that the proposed Synergy D2 Spinal Implants meet or exceed all functional requirements and support their suitability for use.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1999
Ms. Lynn M. Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
K984578 Trade Name: Synergy™ D2 Spinal Implants Regulatory Class: II Product Codes: KWQ, KWP, MNH, and MNI Dated: December 22, 1998 Received: December 23, 1998
Dear Ms. Rodarti:
Re:
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.
4
Page 2 - Ms. Lynn M. 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
Enclosure
5
Page 1 of 2
510(k) Number (if known): K984578
Synergy™ D2 Spinal Implants Device Name:
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 mcans 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 (LS-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 turnor, 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) | |
|---|---|
| Off) | |
| eral Restorative Devices | |
| Prescription Use | |
| (PER 21 CFR 801.109) | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
| K Number | K984578 |
|---|---|
| ---------- | --------- |
6
Page 2 of 2
510(k) Number (if known):
Synergy™ D2 Spinal Implants Device Name:
Indications-For-Use (cont'd):
As a posterior, non-pedicle, screw and hook system, and an auterolateral, 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.
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)
bosella