(202 days)
No
The document describes a mechanical implant and its performance testing, with no mention of AI or ML technologies.
Yes
Explanation: The device is intended to treat a collapsed, damaged, or unstable vertebral body due to tumor or trauma, and it provides anterior spinal column support. It is used to restore function or provide a therapeutic effect in the body.
No
The SYNMESH™ Spacer is a vertebral body replacement device, intended for structural support in the spine, not for diagnosing medical conditions.
No
The device description clearly states it is a titanium vertebral body replacement device, which is a physical hardware implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- SYNMESH™ Spacer Function: The SYNMESH™ Spacer is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted inside the body to provide structural support.
The description clearly indicates a surgical implant for structural support within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SYNMESH™ Spacer is a vertebral body replacement device in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH Spacer is intended to be used with Synthes supplemental internal fixation of the SYNMESH Spacer can be packed with bone graft.
The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Product codes
MQP, MOP
Device Description
The SYNMESH System spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy/vertebrectomy. Different cross section sizes and heights are available to suit the individual pathology and anatomical conditions.
The SYNMESH System spacer consists of a cylindrical round or oblong mesh, end rings, standard rings and screws. The round mesh is used in pairs and is available in various diameters and heights. The oblong mesh is used individually and is also available in various cross-section sizes and heights.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature individuals
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
Non-clinical testing was conducted in alignment with the following standard:
ASTM F2077-14 Standard Test Methods for Intervertebral Body Fusion Device
The following performance tests were evaluated, supporting substantial equivalence:
Static Torsion
Dynamic Torsion
Static Compression
Dynamic Compression
Expulsion
Subsidence
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
May 23, 2019
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
DePuy Synthes Spine Michelle Hughes Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K183054
Trade/Device Name: SYNMESH™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: April 22, 2019 Received: April 24, 2019
Dear Ms. Hughes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183054
Device Name SYNMESH™ System
Indications for Use (Describe)
The SYNMESH™ Spacer is a vertebral body replacement device in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH Spacer is intended to be used with Synthes supplemental internal fixation of the SYNMESH Spacer can be packed with bone graft.
The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
| 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) |
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510(K) SUMMARY
Submitter Information A.
| | Manufacturer: | Synthes USA, LLC
1101 Synthes Avenue
Monument, CO 80132 |
|----|-------------------------|---------------------------------------------------------------------------|
| | Submitter: | DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767 |
| | Contact Person: | Michelle Hughes
325 Paramount Drive
Raynham, MA 02767 |
| | Telephone: | 904-608-1262 |
| | Fax: | 508-828-3797 |
| | Email: | mhughe37@its.jnj.com |
| B. | Date Prepared | April 22, 2019 |
| C. | Device Name | |
| | Trade/Proprietary Name: | SYNMESH™ System |
| | Common/Usual Name: | Implant, fixation, spinal intervertebral body fixation
orthosis device |
| | Regulatory Class: | Class II per 21 CFR § 888.3060 |
| | Review Panel: | Orthopedic |
| | Product Codes: | MOP, spinal vertebral body replacement device |
D. Primary Predicate Device Name
Synthes SynMesh Spacer System cleared on April 23, 2001 via 510(K), K003275.
E. Device Description
The purpose of this premarket notification is to obtain market clearance to add a new longer round mesh spacer to the SYNMESH™ Spacer System.
The SYNMESH System spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally
4
mature individuals following corpectomy/vertebrectomy. Different cross section sizes and heights are available to suit the individual pathology and anatomical conditions.
The SYNMESH System spacer consists of a cylindrical round or oblong mesh, end rings, standard rings and screws. The round mesh is used in pairs and is available in various diameters and heights. The oblong mesh is used individually and is also available in various cross-section sizes and heights.
F. Indications for Use
The SYNMESH™ Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH™ Spacer is intended to be used with the Synthes supplemental internal fixation systems. The interior of the SYNMESH TM Spacer can be packed with bone graft.
The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Summary of Similarities and Differences in Technological Characteristics, G. Performance, and Intended Use
The intended use, technological characteristics, and performance of the new longer SYNMESH System Spacer is consistent with those of the predicate device.
Materials H.
The SYNMESH System Spacer components are manufactured from commercially pure Titanium Grade 2 and 4 (CP-Ti) per ISO 5832-2 and ASTM F 67.
I. Performance Data
Non-clinical testing was conducted in alignment with the following standard:
-
. ASTM F2077-14 Standard Test Methods for Intervertebral Body Fusion Device
The following performance tests were evaluated, supporting substantial equivalence: -
Static Torsion
-
Dynamic Torsion .
-
Static Compression ●
-
Dynamic Compression ●
-
Expulsion
-
Subsidence ●
5
J. Conclusion
The subject device, SYNMESH™ Spacer System is substantially equivalent to the predicate device because the intended use and fundamental scientific technology remain unchanged.