(80 days)
Not Found
No
The document describes a spinal implant system and its components, focusing on materials, intended use for spinal fusion and stabilization, and compatibility with other systems. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are bench testing, not clinical studies involving data analysis.
Yes
The device is described as "intended to promote fusion" and "to provide stabilization to promote fusion," which indicates it is used for the treatment of various spinal conditions.
No
The device description and intended use clearly state that it is an implantable system (hooks, plate/rods, plates, rods, screws, transconnector) used to promote fusion and provide stabilization in the spine, not to identify or diagnose a disease or condition.
No
The device description clearly states it is an implant manufactured from Titanium Aluminum Niobium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to promote fusion and provide stabilization in the cervical and upper thoracic spine. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a transconnector, hooks, plates, rods, and screws made of Titanium Aluminum Niobium. These are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies focus on bench testing (mechanical properties) and state that clinical data was not needed, which is typical for a device with a well-established mechanism of action like spinal implants. IVDs typically require clinical performance data related to their diagnostic accuracy.
In summary, the Synthes Synapse System is a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion and Synapse Systems are indicated for the following:
• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/dislocation
• Atlantoaxial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumor
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Synthes Synapse Transconnector is a top-loading transconnector placed on top of two mono-segmental variable axis screws to cover the exposed spinal cord following laminectomy. The Synthes Synapse Transconnector is designed to be a rigid link between longitudinal rods, and is compatible only with Synthes Synapse System.
The Synthes Synapse Transconnector is a line extension to Synthes Synapse System, and a modification to the Synthes Cervifix transconnector.
The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, occipitocervical junction (occiput-T3), cervical/upper thoracic (C1-T3) spine, upper thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
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)
Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
Synthes Synapse System (K072434 & K070573), Synthes Cervifix (K011969)
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
K090549 page 1 of 2
MAY 2 1 2009
10 510(k) Summary
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Stacey Bonnell
Regulatory Affairs Specialist
Telephone: 610-719-5895 Facsimile: 610-719-5102
Email: bonnell.stacey@synthes.com |
| Date Prepared: | February 27, 2009 |
| Trade Name: | Synthes Synapse Transconnector |
| Common Name: | Posterior Cervical System |
| Classification: | 21 CFR 888.3050 Appliance, Fixation, Spinal Interlaminal
Class II; Orthopaedic and Rehabilitation Devices Panel
Product Code: KWP |
| Predicate Device: | Synthes Synapse System (K072434 & K070573)
Synthes Cervifix (K011969) |
| Device Description: | The Synthes Synapse Transconnector is a top-loading transconnector
placed on top of two mono-segmental variable axis screws to cover the
exposed spinal cord following laminectomy. The Synthes Synapse
Transconnector is designed to be a rigid link between longitudinal rods,
and is compatible only with Synthes Synapse System.
The Synthes Synapse Transconnector is a line extension to Synthes
Synapse System, and a modification to the Synthes Cervifix
transconnector.
The implants are manufactured from Titanium Aluminum Niobium
TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device. |
| Intended Use /
Indications for Use: | Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote fusion of the cervical spine and
occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook
and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon,
OC Fusion and Synapse Systems are indicated for the following:
• Degenerative Disc Disease (DDD) (defined as neck pain of
discogenic origin with degeneration of the disc as confirmed by
patient history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/dislocation
• Atlantoaxial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumor
When used to treat these cervical and occipitocervical conditions,
screws are limited to occipital fixation only.
|
| | Hooks and Rods
The rod and hook components are also intended to provide stabilization |
| | to promote fusion following reduction of fracture/dislocation or trauma
in the cervical/upper thoracic (C1-T3) spine. |
| | Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars |
| | The rods, clamps, screws, nuts, variable axis screws, locking screws,
and transverse bars are intended to promote fusion following reduction
of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). |
| | The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and
3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating
thoracic conditions only. They are not intended to be placed in or treat
conditions involving the cervical spine. |
| | The Synthes CerviFix, Axon, and Synapse Systems can also be linked
to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm
parallel connectors from that system and via the CerviFix tapered rods
using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm
screws and the 5.0 mm/6.0 mm parallel connector. |
| | Warning: This device is not intended for screw attachment or fixation
to the posterior elements (pedicles) of the cervical, thoracic (T4-T12),
or lumbar spine. |
| Comparison of the
technological
characteristics of the
device to the
predicate device: | The Synthes Synapse Transconnector is a result of design modifications
to the predicate device. Synthes has established that it is substantially
equivalent to the predicates in design, function, material, and intended
use. |
| Performance Data
(Nonclinical and/or
Clinical) | Non-Clinical Performance and Conclusions:
Bench testing results demonstrate that the Synthes Synapse System is
substantially equivalent to the predicate device. |
| | Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
....
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Page 12 of 34
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Page 2 of 2
Special 510(k) - Synthes Synapse Transconnector
Page 13 of 34
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
MAY 21 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Synthes Spine % Ms. Stacey Bonnell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K090549
Trade/Device Name: Synthes Synapse System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: April 20, 2009 Received: April 21, 2009
Dear Ms. Bonnell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Stacey Bonnell
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Howard W. Epps
fx
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
page 1 of 2
Indications for Use Statement 9
к 090549
510(k) Number: (if known)
Device Name: Synthes Synapse
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion and Synapse Systems are indicated for the following:
- · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/dislocation
- · Atlantoaxial fracture with instability
- · Occipitocervical dislocation
- · Revision of pervious cervical spine surgery
- · Tumor
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, & Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse
Special 510(k) - Synthes Synapse Transconnector
Page 10 of 34
5
process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
X Prescription Use (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gmin Heis
for (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices .
K090549 510(k) Number.
Special 510(k) - Synthes Synapse Transconnector
Page 11 of 34