(84 days)
Not Found
No
The device description focuses on the mechanical components and materials of a spinal implant system. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is a pedicle screw system and fixation device, which is a type of implant used in surgical procedures to stabilize the spine and assist in healing. This falls under the definition of a therapeutic device as it is intended to treat specific medical conditions and restore normal bodily function.
No
The device is a pedicle screw system, referred to as the SYNERGY™ Spinal System, intended for surgical implantation to stabilize the spinal operative site during fusion procedures. It is a therapy device, not a diagnostic one.
No
The device description explicitly details numerous hardware components made of titanium and stainless steel, including screws, hooks, rods, and instruments, which are intended for surgical implantation and stabilization of the spine. There is no mention of any software component.
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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The SYNERGY™ Spinal System is a surgical implant designed to stabilize the spine during fusion procedures. It is physically implanted into the patient's body.
- Intended Use: The intended use describes the conditions the device is used to treat and the surgical procedures involved. It does not mention any analysis of biological specimens.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
As a pedicle screw system, it 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 receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; 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.
As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications are:
-
- Degenerative Disc Disease (as defined by chronic back pain of 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 levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.
Product codes
MNH, KWP, KWQ
Device Description
The SYNERGY™ Spinal System is intended to be used a part of a temporary construct that assists normal healing and is not intended to replace normal body structures. It is intended to help stabilize the spinal operative site during fusion procedures. It attaches to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
The posterior application components are grouped as follows:
-
- INTEGRAL TM 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 INTEGRALTM Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation (see INDICATIONS).
-
- 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).
The anterior application components are grouped as follows:
-
- 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).
Material: The implantable components may be made from either titanium or stainless steel. The titanium version consists of surgical implant grade titanium alloy as described by ASTM Standard F136 (Ti 6A1-4V ELI), and commercially pure titanium, grade 2 as described by ASTM Standard F67 (CP Ti, Gr. 2). The stainless steel version consists of surgical implant grade stainless steel as described by ASTM standard F1314 (22-13-5 Stainless Steel), and surgical implant grade stainless steel as described by ASTM standard F138, Grade 2 (316L Stainless Steel).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine, T1 to Sacrum/Ilium, T10 to L3, T5 to L5
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons fully experienced in the use of such implants and the required specialized spinal surgery techniques, hospitals
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 document mentions material certifications, in-house SOP's, and ASTM Standards for performance, and mechanical testing for substantial equivalence, but not specific performance studies with quantitative results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K934429, K950709, K940631, K950099, K973836
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
K974749 (plot 5)
510(k) Summary of Safety and Effectiveness
MAR 1 3 1998
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact:
Regulatory Affairs Department Cross Medical Products, Inc. 5160-A Blazer Memorial Parkway Dublin, OH 43017-1339 614-718-0530, Fax 614-718-0540
Device Name:
Trade Name: SYNERGY™ Spinal System- Closed VLSTM
Common Name(s): Anterior Spine Implants, Posterior Spine Implants, Universal Spine System
Classification Name(s):
Spinal Intervertebral Body Fixation Orthosis Appliance, Fixation, Spinal Interlaminal Spondylolisthesis Spinal Fixation Device System
Establishment Registration: 1526354
Classification:
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The Orthopaedic and Rehabilitation Devices Panel assigned the unique device classification codes KWP and KWQ to this device system. The published physical description of these devices is in 21 CFR, 888.3050 and 888.3060. In addition, they are presently Class II medical devices. Class II medical devices are subject to Performance Standards. This device is also categorized under MNH (Spondylolisthesis Spinal Fixation), which is unclassified.
Performance Standards:
Performance Standards applicable to the Cross® Medical- SYNERGY™ Spinal System have not been published by FDA. Cross® Medical Products, Inc. produces this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present. Voluntary performance standards, such as materials certifications, in-house SOP's and/or ASTM Standards are utilized as appropriate.
1
K974749 (p.2 of 5)
Substantially Equivalent Device(s):
-
- SYNERGYTM Spinal System: K973836
Device Description:
al de la de la final de la color de la conference de la color de la color de la controlla controlla con
Background: This document summarizes safety and effectiveness information for the SYNERGY™ Closed VLS™ contained in the 510(k) Premarket Notification submitted to FDA in support of its substantial equivalence.
Purpose: The SYNERGY™ Spinal System is intended to be used a part of a temporary construct that assists normal healing and is not intended to replace normal body structures. It is intended to help stabilize the spinal operative site during fusion procedures. It attaches to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
The posterior application components are grouped as follows:
-
- INTEGRAL TM 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 INTEGRALTM Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation (see INDICATIONS).
-
- 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).
The anterior application components are grouped as follows:
-
- INTEGRAL™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
2
K974749 (p. 3 of 5)
-
- Vertebral Washers.
-
- Fixed Transverse Connectors with Set Screws.
-
- Rods.
-
- Instruments.
-
- Sterilizer case(s).
Material: The implantable components may be made from either titanium or stainless steel. The titanium version consists of surgical implant grade titanium alloy as described by ASTM Standard F136 (Ti 6A1-4V ELI), and commercially pure titanium, grade 2 as described by ASTM Standard F67 (CP Ti, Gr. 2). The stainless steel version consists of surgical implant grade stainless steel as described by ASTM standard F1314 (22-13-5 Stainless Steel), and surgical implant grade stainless steel as described by ASTM standard F138, Grade 2 (316L Stainless Steel).
Indications for Use:
and the selection of the change has checked the states of the since
As a pedicle screw system, it 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 receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; 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.
As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications are:
-
- Degenerative Disc Disease (as defined by chronic back pain of 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.
3
K974749 (p. 4 of 5)
For posterior, non-pedicle screw use, the levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.
Contraindications and Cautions:
The existence of the following conditions generally excludes candidates from treatment with spinal implants. Patients with rigid scoliotic curves vague spinal anatomy, bony abnormalities preventing safe screw fixation, metal sensitivities, morbid obesity, severe osteopenia, active localized infections or other disseminated infections (septicemia). In general, the SYNERGY™ Spinal System should only be implanted by surgeons fully experienced in the use of such implants and the required specialized spinal surgery techniques.
Note: The Cross® Medical- SYNERGY™ Spinal System Instrumentation Technique Manual should be carefully followed. It supplies important information on proper usage of the implants and instruments.
Packaging: All packages containing implants or instruments should be sealed and intact upon receipt. The product should not be used and should be immediately returned to Cross® Medical Products, Inc. if the package or product is damaged.
Sterilization:
leis for the finis for the libert and the block has described on the closed on the c
The SYNERGY™ Spinal System is shipped non-sterile. All packaging materials must be removed prior to sterilization.
High temperature steam sterilization should be used, with the following cycle having been laboratory validated:
| Method: | Steam |
|---|---|
| Cycle: | Gravity |
| Temperature: | 250 degrees F (121 degrees C) |
| Exposure Time: | 60 minutes |
Note: It is recommended to dry and/or cool the parts to prevent condensation after the steam cycle .. Only sterile products should be used in the operative field.
The recommended sterilization cycle is based on HIMA/AORN protocols. Other sterilization methods and cycles may also be suitable. However, individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques.
Product Complaints:
4
K974749 (p.5 of 5)
Any dissatisfaction with the product quality, labeling or performance should be reported to Cross® Medical Products, Inc. immediately by the customer or user. Furthermore, if any of the implants "malfunction," (i.e. do not meet any of their performance specifications or otherwise do not perform as intended) and may have caused or contributed to the death or serious injury of the patient, Cross® Medical Products, Inc. should be notified immediately by telephone, fax, or written correspondence.
When filing a complaint, the name, part number and lot number of the part should be provided along with the name and address of the person filing the complaint. In addition, the nature of the complaint should be clearly communicated along with a notification of whether a written report from Cross® Medical Products, Inc. is requested.
Instrumentation:
Three additional device specific instruments are necessary for insertion and anchoring of the SYNERGY™ Closed VLS™ that are not already part of the commercially available SYNERGY™ Spinal System. The instruments are made from stainless steel meeting ASTM A276, ASTM A564/A564M, and ASTM F899 standards. Established medical grade plastics (Ultem and Radel) and Silicone Rubber are used to construct the handles, cases, etc.
Substantial Equivalence:
The SYNERGY™ Closed VLS™ components are substantially equivalent to the SYNERGY™ Anterior and Posterior, Stainless Steel and Titanium Spinal System as cleared under K934429, K940631, K950099, K950709, and K973836.
All of these devices are used to treat similar or the same conditions, have essentially the same cautions and contraindications for use, and have equivalent potential for complications for risk of use. All represent a long standing, basic design concept and in terms of safety and effectiveness, differ only in minor details.
Conclusion:
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, Cross® Medical Products, Inc. believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to existing legally marketed screws as components of universal spine systems.
5
Image /page/5/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" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with a double helix-like structure below it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Mr. Phil Mellinger CROSS® Medical Products, Inc. 5160-A Blazer Memorial Parkway Dublin, Ohio 43017-1339
Re : K974749 SYNERGY™ Closed Variable Locking Screw (VLS™)Assembly Regulatory Class: II Product Codes: MNH, KWP, and KWQ Dated: December 17, 1997 Received: December 19, 1997
Dear Mr. Mellinger:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act). found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified 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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501 (f) (1) of the Act.
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III
6
Page 2 - Mr. Phil Mellinger
device under Section 513(f) of the Act. Class III devices device under bouave an approved premarket approval (PMA) application prior to marketing. "Accordingly:
- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws 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 receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- When used as a pedicle screw system, this device ● system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- . The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this . device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
7
See Warnings, Precautions, and Potential Adverse Events Sec warnings, tresulage insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item ocher than bevore is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of 4. previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above .
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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the Mechanical testing of a spinal system device components. consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
8
Page 4 - Mr. Phil Mellinger
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An 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 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 Also, please note the Office of Compliance at (301) 594-4639. 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 (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
9
510(k) Number (if known): K974749
Device Name: SYNERGY™ Spinal System- Closed VLSTM
Indications For Use:
As a pedicle screw system, it 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 receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; 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.
As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications are:
-
- Degenerative Disc Disease (as defined by chronic back pain of 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. 6.
-
- Vertebral fracture or dislocation.
- Tumors. 8.
-
- Spondylolisthesis.
-
- Stenosis.
-
- Pseudarthrosis.
-
- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle screw use, the levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.
ーー
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pecole
Jivision of General Restorat 510k) Numb
Prescription Use > (Per 21 CFR 801.109)
OR
Over-The-Counter Use