(73 days)
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 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 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, 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.
OC Fusion System
The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, and Synthes Synapse System.
The OC Fusion System is indicated for skeletally mature patients using allograft and/or autograft for the following indications:
· Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/dislocation
- Atlanto/axial fracture with instability
- · Occipital-cervical dislocation
- · Revision of previous cervical spine surgery
- · Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed into the cervical spine.
The Synapse System is a hook, pedicle screw, and rod spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and CerviFix System also included in the indications for use statement are additional hook, pedicle screw, and rod spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks; interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors.
The OC Fusion System consists of occipital plates, occipital screws, and rods intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. The OC Fusion System can be used with components from the Synthes CerviFix System including Axon and Synapse components to create a complete occipital-cervical-thoracic spinal construct.
Fixation of the rods included in the Synapse and OC Fusion Systems is achieved by using hooks from one of the aforementioned cleared systems. System components in the Synapse and OC Fusion Systems are implanted with Class I general use surgical instruments.
The provided text describes a 510(k) premarket notification for medical devices, specifically the Synapse System and OC Fusion System, which are spinal interlaminal fixation orthoses. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study that defines and tests against acceptance criteria for a new device's performance characteristics.
Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not explicitly provided in this type of regulatory submission. This document confirms the material, intended use, and general performance testing (mechanical testing for a specific component) to demonstrate equivalence.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria for a newly developed performance characteristic nor detailed reported device performance against such criteria. The submission states that the device was evaluated using mechanical testing and found to be "substantially equivalent to or better than the predicate devices." This implies that the 'acceptance criteria' were likely an equivalence or superiority comparison to the predicate device's established performance, rather than specific numerical thresholds for novel performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to or betterment of predicate devices in mechanical testing (static compression bending, dynamic compression bending, dynamic torsion testing). | "Test results and analyses showed that the proposed components to the Synapse and OC Fusion Systems were substantially equivalent to or better than the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes mechanical testing for the OC Fusion System components. It does not specify a sample size (e.g., number of test articles) for this mechanical testing. There is no information provided regarding data provenance (country of origin, retrospective/prospective) as the testing described is in vitro mechanical testing, not human-patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The study described is mechanical testing of physical device components, not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of ambiguous cases, particularly in imaging, and are not relevant to mechanical performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no MRMC study or AI component mentioned in this document. This submission is for physical spinal fixation devices, not a diagnostic or AI-powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or software device described in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing performed, the "ground truth" would be the direct physical measurements of device strength, fatigue, and other mechanical properties under controlled conditions, compared against the equivalent properties of the predicate devices according to ASTM F2706-08.
8. The sample size for the training set
This is not applicable. There is no training set mentioned as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the first profile being the most prominent and the other two receding into the background. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2014
Synthes USA Products, LLC Mr. Mitch Ohiwa Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K141897
Trade/Device Name: Synapse System and OC Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: July 11, 2014 Received: July 14, 2014
Dear Mr. Ohiwa:
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}------------------------------------------------
Page 2 - Mr. Mitch Ohiwa
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#Alean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K141897
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 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 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 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, 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Indications for Use
510(k) Number (if known) K141897
Device Name OC Fusion System
Indications for Use (Describe)
The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, and Synthes Synapse System.
The OC Fusion System is indicated for skeletally mature patients using allograft and/or autograft for the following indications:
· Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/dislocation
- Atlanto/axial fracture with instability
- · Occipital-cervical dislocation
- · Revision of previous cervical spine surgery
- · Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed into the cervical spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
510(K) SUMMARY
A. Submitter Information
| Submitter: | Synthes USA Products, LLC325 Paramount DriveRaynham, Massachusetts 02767 |
|---|---|
| Contact Person: | Mitch OhiwaDePuy Synthes Spine325 Paramount DriveRaynham, Massachusetts 02767 |
| Telephone Number:Fax Number:E-mail: | 508-828-3225508-828-3267mohiwa@its.jnj.com |
B. Date Prepared
September 2014
C. Device Name
| Trade/Proprietary Name: | Synapse SystemOC Fusion System |
|---|---|
| Common/Usual Name: | Spinal interlaminal fixation orthosis |
| Device Classification and Regulation: | Class II, per 21 CFR 888.3050 |
| Subsequent Regulation: | 21 CFR 888.3070 |
| Classification Product and Panel Code: | KWP (Orthopedic) |
| Subsequent Product and Panel Codes: | MNH (Orthopedic)MNI (Orthopedic) |
D. Predicate Device Nameu
Rtlo ct { "Rtgf lecyg<" Synthes Synapse System (most recently K133698)
Cfffkkqpcn'Rtgf kecygu" Synthes OC Fusion System (most recently K091689)."cpf Synthes CerviFix/Axon (K023675, most recently K030377 for CerviFix System)
{6}------------------------------------------------
E. Submission Purpose
The purpose of this submission is to include additional components in the Synapse and OC Fusion Systems.
F. Device Description
The Synapse System is a hook, pedicle screw, and rod spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and CerviFix System also included in the indications for use statement are additional hook, pedicle screw, and rod spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks; interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors.
The OC Fusion System consists of occipital plates, occipital screws, and rods intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. The OC Fusion System can be used with components from the Synthes CerviFix System including Axon and Synapse components to create a complete occipital-cervical-thoracic spinal construct.
Fixation of the rods included in the Synapse and OC Fusion Systems is achieved by using hooks from one of the aforementioned cleared systems. System components in the Synapse and OC Fusion Systems are implanted with Class I general use surgical instruments.
G. Indication for Use
Synapse System
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
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
{7}------------------------------------------------
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 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, 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.
OC Fusion System
The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) and screws (T1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.
The OC Fusion System is indicated for skeletally mature patients using allograft and/or autograft for the following indications:
- Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with ● degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis ●
- . Spinal Stenosis
- . Fracture/dislocation
- . Atlanto/axial fracture with instability
- . Occipital-cervical dislocation
- . Revision of previous cervical spine surgerv
- Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed into the cervical spine.
H. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use
The proposed additional components to the Synapse and OC Fusion Systems share the same intended use, indications for use, and technological characteristics as the previously cleared components in the Synapse, OC Fusion, and CerviFix/Axon Systems.
{8}------------------------------------------------
I. Materials
The proposed additional components to the Synapse and OC Fusion Systems are manufactured from titanium aluminum niobium (Ti-6Al-7Nb (TAN)). The same material is used in the components of the previously cleared Synapse. OC Fusion, and CerviFix/Axon Systems. The material conforms to ASTM F1295-11 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications and ISO 5832-11 Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminum 7-niobium allov.
J. Performance Data
The proposed additional components to the Synapse System required no additional mechanical testing. The proposed additional components to the OC Fusion System were evaluated in mechanical testing including static compression bending testing, dynamic compression bending testing, and dynamic torsion testing. The mechanical tests performed followed ASTM F2706-08, Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. Test results and analyses showed that the proposed components to the Synapse and OC Fusion Systems were substantially equivalent to or better than the predicate devices.
K. Conclusion
The substantial equivalence justification demonstrates that the proposed additional components to the Synapse and OC Fusion Systems are as safe, as effective, and perform as well as the predicate components in the Synapse, OC Fusion, and Axon Systems.
§ 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.