(100 days)
Not Found
No
The document describes a system of mechanical implants for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated to "promote fusion" and provides "stabilization" in the spine to treat various medical conditions, including degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, and tumors. These are therapeutic applications.
No
The device description and intended use clearly state that the Synthes Synapse System consists of implants for fixation of the spine to promote fusion, treat fractures/dislocations, and trauma. It is a surgical implant system, not a diagnostic tool.
No
The device description explicitly states that the system consists of physical implants (screws, hooks, rods, etc.) made from Titanium Aluminum Niobium. This indicates it is a hardware medical device, not software-only.
Based on the provided text, the Synthes Synapse System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information about a person's health. The description of the Synthes Synapse System clearly states it is a system of implants (screws, rods, hooks, etc.) designed for fixation of the cervical and upper thoracic spine.
- The intended use and device description focus on surgical implantation and mechanical support of the spine. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies described are bench testing (non-clinical) and do not involve clinical data related to diagnostic accuracy.
Therefore, the Synthes Synapse System is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and occrpitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, 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, 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, MNH, MNI
Device Description
The Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks, rods, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the cervical, and/or upper thoracic spine (C1 – T3). A complete occipital-cervical-thoracic construct can be created by using components that have been previously cleared within the Synthes CerviFix System and/or the Synthes Axon System.
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, occipitocervical junction (occiput-T3), cervical/upper thoracic (C1-T3) spine, upper thoracic spine (T1-T3), T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
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
K070573
510(k) Summary
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Susan Lewandowski
Manager, Spine Regulatory Affairs
Telephone: 610-719-5712
Facsimile: 610-719-5102
Email: lewandowski.susan@synthes.com |
| Date Prepared: | May 2007 |
| Trade Name: | Synthes Synapse System |
| Common Name: | Posterior Cervical System |
| Classification: | 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis
Class II
Orthopaedic and Rehabilitation Devices Panel
Product Code KWP
21 CFR 888.3070 - Pedicle Screw Spinal System
Class II
Orthopaedic and Rehabilitation Devices Panel
Product Codes MNH, MNI |
| Predicate Device: | Synthes CerviFix System - Axon Components - K023675, herein
referred to as the Axon System
Synthes CerviFix System - K030377 |
| Device Description: | The Synthes Synapse System consists of cancellous and cortex
polyaxial screws, hooks, rods, transverse bars, parallel
connectors, transconnectors, and locking screws. These implants
are designed for fixation of the cervical, and/or upper thoracic
spine (C1 – T3). A complete occipital-cervical-thoracic construct
can be created by using components that have been previously
cleared within the Synthes CerviFix System and/or the Synthes
Axon System. |
| Device Description: | The implants are manufactured from Titanium Aluminum
Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the
predicate device. |
| Intended Use / | Synthes Synapse System is indicated for the following: |
| Indications for Use: | |
| | Hooks, Plate/Rods, Rods and Screws
When intended to promote fusion of the cervical spine and |
| | occipitocervical junction (occiput-T3), the plate/rod, rod, hook |
| | and screw (3.2 mm cortex) components of the Synthes Cervifix, |
| | Axon, 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, 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, or lumbar spine. |
| Comparison of the
technological
characteristics of the
device to the
predicate device: | The Synthes Synapse System is a result of design modifications
to the predicate device. It is substantially equivalent to the
predicate 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. |
1
:
and the comments of the country
2
and the comments of the comments of the comments of
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2007
Synthes Spine % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, PA 19380
Re: K070573
Trade/Device Name: Synthes Synapse System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: MNI Dated: May 9, 2007 Received: May 10, 2007
Dear Ms. Lewandowski:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Susan Lewandowski
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2 Indications for Use Statement
Special 510(k) Device Modification
Indications for Use Statement
510(k) Number:
Device Name: Synthes Synapse System (modification to Synthes Axon System) Synthes Synapse System is indicated for the following: Indications: Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occrpitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, 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, 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
Synthes Synapse System CONFIDENTIAL
Special 510(k) Page 3 of 29 p. 1 of 2
6
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.
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)
Mark M. Melkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070573
Special 510(k) Page 4 of 29 2 of 2
Synthes Synapse System CONFIDENTIAL