(29 days)
Not Found
No
The document describes a spinal implant system consisting of mechanical components (rods, screws, plates, etc.) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies section also indicates that the design and technological characteristics remain unchanged from predicate devices, further suggesting a lack of novel AI/ML integration.
Yes
The device explicitly states its intended use to "provide stabilization as an adjunct to fusion" and to "promote fusion" for various spinal conditions, classifying it as a therapeutic device.
No
Explanation: The device is an implantable surgical system (hooks, plate/rods, plates, rods, and screws) intended for stabilization as an adjunct to fusion of the cervical and upper thoracic spine, not for diagnosing medical conditions.
No
The device description explicitly details various hardware components made of titanium alloys, such as rods, plates, hooks, screws, and clamps, intended for surgical implantation. There is no mention of any software component being the primary or sole medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as providing stabilization as an adjunct to fusion of the cervical junction and upper thoracic spine for various conditions like DDD, spondylolisthesis, fracture/dislocation, etc. This is a surgical implant used in vivo (within the body).
- Device Description: The device description details components like hooks, rods, plates, and screws made of titanium alloys. These are physical implants designed to be surgically placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These Systems are intended for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to fusion of the cervical junction (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 skeletally mature patients using allograft 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 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 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 and 4.0 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.
The Synthes System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-12) or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNI, MNH
Device Description
The tapered rods are intended to create a single construct by linking system components that receive different rod diameters. These rods are manufactured from titaniumaluminum-niobium (Ti-6Al-7Nb (TAN)). These rods taper from a diameter of 3.5 mm or 4.0 mm to a diameter of 5.5 mm and are both 500 mm in length.
The Synthes Synapse System is a hook, rod and pedicle screw spinal system intended to provide posterior stabilization of the upper spine (C1-T3) as an adjunct to fusion in skeletally mature patients. This system consists of multiple components manufactured from either titanium aluminum niobium (Ti-6Al-7Nb (TAN)) or commercially pure grade 4 Titanium and include rods (straight, tapered and curved), plate/rods, hooks, clamps, screws, nuts, variable axis screws, locking screws, transconnector clamps, transverse bars, parallel connectors and variable axis/top loading transconnectors. These system components are implanted using Class I general surgical instruments. A complete occipital-cervical-thoracic construct can be created by using components from the previously cleared Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System. When combined with the Synthes Universal Spinal System (including Matrix) using parallel connectors or tapered rods, constructs can extend from the occiput to the lower spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical junction (occiput-T3), cervical spine and occipitocervical junction (occiput-T3), cervical/upper thoracic (C1-T3) spine, upper thoracic spine (T1-T3), occipital, posterior elements (pedicles) of the cervical, thoracic (T4-T12) or lumbar spine.
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)
Since the subject devices have been extensively tested in their predicate submissions and their designs and technological characteristics remain unchanged, an engineering rationale is provided in lieu of performance testing for the proposed modification.
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
§ 888.3050 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of three human profiles. The profiles are connected and appear to be emerging from a single point. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2014
DePuy Synthes Spine, a Johnson & Johnson Company Ms. Jaclyn Porsolt Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K142460
Trade/Device Name: Synapse System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: August 29, 2014 Received: September 2, 2014
Dear Ms. Porsolt:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald刷Aean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142460
Device Name Synapse System
Indications for Use (Describe) These Systems are intended for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to fusion of the cervical junction (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 skeletally mature patients using allograft 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 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 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 and 4.0 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.
The Synthes System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.
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.
Type of Use (Select one or both, as applicable)
즈 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Submitter Information A.
| DePuy Synthes Spine | ||
|---|---|---|
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person: | Jaclyn Porsolt | |
| Address: | 325 Paramount Drive | |
| Raynham, MA 02767 | ||
| Telephone number: | (508) 828-3269 | |
| Fax number: | (508) 828-3797 | |
| Email: | jporsol1@its.jnj.com | |
| B. Date Prepared | September 30, 2014 | |
| C. Device Name | ||
| Trade/Proprietary Name: | Synapse System | |
| Common/Usual Name: | Spinal Interlaminal Fixation Orthosis | |
| Classification and Regulation: | ||
| Classification Product and | Class II per 21 CFR 888.3050 | |
| Panel Code: | KWP; Orthopedic | |
| Subsequent Regulation: | ||
| Subsequent Classification | 21 CFR 888.3070 | |
| Product and Panel Code: | MNI; Orthopedic | |
| MNH: Orthopedic |
Predicate Device Name D.
Trade names: Primary Predicate: Synthes Synapse System (most recently cleared K091689) Additional Predicate: DePuy EXPEDIUM Spine System (most recently cleared K111136) Additional Predicate: Synthes Matrix Spine System (K100634)
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E. Device Description
The tapered rods are intended to create a single construct by linking system components that receive different rod diameters. These rods are manufactured from titaniumaluminum-niobium (Ti-6Al-7Nb (TAN)). These rods taper from a diameter of 3.5 mm or 4.0 mm to a diameter of 5.5 mm and are both 500 mm in length.
The Synthes Synapse System is a hook, rod and pedicle screw spinal system intended to provide posterior stabilization of the upper spine (C1-T3) as an adjunct to fusion in skeletally mature patients. This system consists of multiple components manufactured from either titanium aluminum niobium (Ti-6Al-7Nb (TAN)) or commercially pure grade 4 Titanium and include rods (straight, tapered and curved), plate/rods, hooks, clamps, screws, nuts, variable axis screws, locking screws, transconnector clamps, transverse bars, parallel connectors and variable axis/top loading transconnectors. These system components are implanted using Class I general surgical instruments. A complete occipital-cervical-thoracic construct can be created by using components from the previously cleared Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System. When combined with the Synthes Universal Spinal System (including Matrix) using parallel connectors or tapered rods, constructs can extend from the occiput to the lower spine.
- F. Intended Use (proposed changes highlighted in blue font)
Synthes Synapse System
These Systems are intended for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft 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 ●
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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 and 4.0 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.
The Synthes Synapse System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.
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.
Summary of Similarities and Differences in Technological Characteristics, G. Performance and Intended Use
The technological characteristics of the tapered rods and Synapse System that are the subjects of this submission remain unchanged from their predicate versions in their design, material, and performance. The intended use of the subject devices also remains unchanged from their predicate versions.
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H. Materials
The tapered rods, which are the subject of this submission, previously cleared with the Matrix System, are available in titanium alloy conforming to ASTM F-1295 specifications.
The previously cleared System components are available in titanium alloy conforming to ASTM F-1295 specifications.
I. Performance Data
Since the subject devices have been extensively tested in their predicate submissions and their designs and technological characteristics remain unchanged, an engineering rationale is provided in lieu of performance testing for the proposed modification.
J. Conclusion
Substantial Equivalence Justification demonstrates that the devices are as safe, as effective, and perform as well as the predicate devices because the intended use and technological characteristics remain unchanged. The engineering rationale further demonstrates that the subject tapered rods can be added to the Synapse System to expand the system's compatibility for use with the EXPEDIUM Spine System.