(53 days)
Not Found
No
The device description focuses on the material and physical form of the mesh and does not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as being used for "reinforcement of weak bony tissue in orthopedic procedures," which indicates a therapeutic purpose.
No
The device is described as a mesh used for the reinforcement of weak bony tissue in orthopedic procedures, which is a structural or supportive function, not a diagnostic one.
No
The device description explicitly states it consists of physical components (flat mesh, preformed cylinders, rings, and screws) made from titanium. It is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the reinforcement of weak bony tissue in orthopedic procedures." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description details a mesh and cylinder made of titanium, designed to be implanted to reinforce bone. This is a physical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to physically support bone.
N/A
Intended Use / Indications for Use
Indication for use is for the reinforcement of weak bony tissue in orthopedic procedures.
Product codes (comma separated list FDA assigned to the subject device)
EZX
Device Description
The Synthes SynMesh consists of both flat mesh and preformed round and oval shaped mesh cylinders. The flat mesh is intended to be customized to a design and geometry that satisfies the patients anatomical defect. In addition, rings and screws are available to reinforce the cylinders. The preformed cylinders are offered in various sizes. The mesh and preformed cylinders are manufactured from commercially pure titanium (ASTM F67). The dimensions of the flat mesh are 90 x 112mm. The preformed cylinders are:
| TYPE | X(mm) | Y(mm) | Height Z(mm) |
|---|---|---|---|
| ROUND | 15 | 30 | |
| 15 | 50 | ||
| 15 | 70 | ||
| OVAL | 17 | 22 | 50 |
| 17 | 22 | 70 | |
| 17 | 22 | 90 | |
| OVAL | 22 | 28 | 50 |
| 22 | 28 | 70 | |
| 22 | 28 | 90 | |
| OVAL | 26 | 33 | 50 |
| 26 | 33 | 70 | |
| 26 | 33 | 90 | |
| RING | 17 | 22 | 4.8 |
| 22 | 28 | 4.8 | |
| 26 | 33 | 4.8 | |
| SCREW | M3 x6.5 | NA | NA |
The range of dimensional characteristics of the SynMesh system is identical to the DePuy Motech Surgical Titanium Mesh. The hole to metal ratio of the SynMesh system falls within the range of hole to metal ratio of the DePuy Motech Surgical Titanium Mesh. Material composition is identical to the DePuy Motech Surgical Titanium Mesh. CP Titanium is an established biocompatible material. This system is provided non-sterile; moist heat sterilization is recommended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgical procedures
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)
Based on this information the mechanical characteristics fall within the range of mechanical characteristics of the DePuy Motech Surgical Titanium Mesh.
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
OFC 18 1998
Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (U.S.A.) 1690 Russell Road Paoli. PA 19301
(610) 647-9700 Contact: James McCracken 10/23/1998
Device: SYNTHES SynMesh compared to the DePuy Motech Surgical Titanium Mesh (K900138).
The Synthes SynMesh consists of both flat mesh and preformed round and oval shaped mesh cylinders. The flat mesh is intended to be customized to a design and geometry that satisfies the patients anatomical defect. In addition, rings and screws are available to reinforce the cylinders. The preformed cylinders are offered in various sizes. The mesh and preformed cylinders are manufactured from commercially pure titanium (ASTM F67). Indication for use is in reinforcement of weak bony tissue in orthopedic surgical procedures.
The dimensions of the flat mesh are 90 x 112mm. The preformed cylinders are:
| TYPE | X(mm) | Y(mm) | Height
Z(mm) |
|-------|---------|-------|-----------------|
| ROUND | 15 | | 30 |
| 15 | | | 50 |
| 15 | | | 70 |
| OVAL | 17 | 22 | 50 |
| 17 | | 22 | 70 |
| 17 | | 22 | 90 |
| OVAL | 22 | 28 | 50 |
| 22 | | 28 | 70 |
| 22 | | 28 | 90 |
| OVAL | 26 | 33 | 50 |
| 26 | | 33 | 70 |
| 26 | | 33 | 90 |
| RING | 17 | 22 | 4.8 |
| 22 | | 28 | 4.8 |
| 26 | | 33 | 4.8 |
| SCREW | M3 x6.5 | NA | NA |
The range of dimensional characteristics of the SynMesh system is identical to the DePuy Motech Surgical Titanium Mesh. The hole to metal ratio of the SynMesh system falls within the range of hole to metal ratio of the DePuy Motech Surgical Titanium Mesh. Based on this information the mechanical characteristics fall within the range of mechanical characteristics of the DePuy Motech Surgical Titanium Mesh.
The SYNTHES SynMesh is indicated for the same clinical indications as that of the DePuy Motech Surgical Titanium Mesh.
1
Material composition is identical to the DePuy Motech Surgical Titanium Mesh. CP Titanium is an established biocompatible material.
This system is provided non-sterile; moist heat sterilization is recommended.
Based on the above, the SYNTHES SynMesh is substantially equivalent to the DePuy Motech Surgical Titanium Mesh.
2
Image /page/2/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Mr. James McCracken Director, Regulatory, Clinical and Compliance Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
Re: K983766
Synthes SynMesh Regulatory Class: II Product Code: EZX Dated: October 23, 1998 Received: October 26, 1998
Dear Mr. McCracken:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. James McCracken
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
- Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
1983766 510(k) Number (if known): NA
Device Name: SynMesh
Indications for Use:
Indication for use is for the reinforcement of weak bony tissue in orthopedic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use _
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983766
SynMesh 510(k)
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