(44 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing "stabilization as an adjunct to fusion" for various spinal conditions, and its components include "rods, clamps, screws, nuts, variable axis screws, locking screws and transverse bars," indicating its use in promoting physiological healing and stability within the body.
No
This device is comprised of hooks, plates, rods, and screws intended for spinal stabilization and fusion, not for diagnosing medical conditions.
No
The device description clearly states it is a "hook and pedicle screw spinal system" composed of "multiple components" including "bone screws, pedicle screws and hooks," which are physical implants. It also mentions "class I surgical instruments" used for implantation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "hook and pedicle screw spinal system" composed of components like "bone screws, pedicle screws and hooks," "rods," and "plates." These are implanted surgically to provide spinal fixation.
- Intended Use: The intended use describes providing "stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction" and "promote fusion following reduction of fracture/dislocation or trauma." This involves surgical implantation and mechanical support within the body.
The device is a surgical implant used for spinal fixation, which falls under the category of medical devices, but not specifically in vitro diagnostics.
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 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.
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 paralle1 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, MNI, MNH
Device Description
The Synapse System is a hook and pedicle screw 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 and pedicle screw 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. These system components are implanted using class I surgical instruments.
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
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)
A rationale is provided in place of performance testing for the proposed curved rods.
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.
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.
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K133698 Page 1 of 4
510(K) SUMMARY
JAN 1 6 2014
Submitter Information A.
Submitter:
Synthes USA Products LLC 1302 Wrights Lane East West Chester, Pennsylvania 19380
Contact Person:
Telephone number: Fax number: Email:
Laura Bleyendaal DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 (508) 828-3267 (508) 828-3797 LBleyend@its.jnj.com
B. Date Prepared January 15, 2014
C. Device Name
Trade/Proprietary Name: Common/Usual Name:
Synapse System Spinal interlaminal fixation orthosis
Class II, per 21 CFR §888.3050
Subsequent Regulation:
Device Classification
and Regulation:
21 CFR §888.3070
Classification Product and Panel Code:
KWP; Orthopedic
Subsequent Product and Panel Codes:
MNI; Orthopedic MNH; Orthopedic
D. Predicate Device Name
Synthes Synapse System (most recently cleared K091689) Trade name: Sierra™ System (K062934, K080526)
1
Altius™ OCT System (K033961, K043229)
E. Device Description
The Synapse System is a hook and pedicle screw 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 and pedicle screw 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. These system components are implanted using class I surgical instruments.
Indications for Use F.
.
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 .
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.
2
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 (TI-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 paralle1 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.
G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The indications for use, intended use and technological characteristics, such as design and material, of the proposed curved rods are the same as, or similar to, those of the predicate devices from the Synapse System, Sierra™ System and Altius™ OCT System.
H. Materials
The proposed curved rods are manufactured from the same material, titanium aluminum niobium (Ti-6A1-7Nb (TAN)), as the previously cleared Synapse System curved rods. The material conforms to ASTM F-1295-11 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 7niobium alloy.
【. Performance Data
A rationale is provided in place of performance testing for the proposed curved rods.
3
J. Conclusion
The substantial equivalence justification demonstrates that the proposed curved rods are substantially equivalent to the predicate devices in the Synapse System, the Sierra™ System and the Altius™ OCT System.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, with three curved lines forming the body and head.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G608 Silver Spring, MD 20993-0002
January 16, 2014
Synthes USA Products, LLC Ms. Laura Blevendaal Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K133698
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: December 20, 2013 Received: December 23, 2013
Dear Ms. Bieyendaal:
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
5
Page 2 - Ms. Laura Bleyendaal
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Lori A. Wigqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K133698
Device Name: Synapse System
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 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.
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.
7
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.
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
·
ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Zane W. Witte S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133698