SYNTHES SYNMESH by SYNTHES (USA)

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.

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Acceptance Criteria and Study for SYNTHES SynMesh (K983766)

The SYNTHES SynMesh is a Class II medical device, and its clearance was based on Substantial Equivalence to a legally marketed predicate device, the DePuy Motech Surgical Titanium Mesh (K900138). This means that a direct study proving the device meets specific performance acceptance criteria in an independent manner was not performed in this submission. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (SYNTHES SynMesh)
Indications for Use	Indication for use is for the reinforcement of weak bony tissue in orthopedic surgical procedures. (Matching predicate device's indications)	The SYNTHES SynMesh is indicated for the same clinical indications as that of the DePuy Motech Surgical Titanium Mesh: "reinforcement of weak bony tissue in orthopedic surgical procedures."
Device Configuration	Similar range of dimensions and configurations (flat mesh, round/oval cylinders, rings, screws) to the predicate device.	The SynMesh offers flat mesh (90x112mm) and preformed cylinders (various sizes: ROUND X=15mm, H=30, 50, 70mm; OVAL X=17, Y=22, H=50, 70, 90mm; OVAL X=22, Y=28, H=50, 70, 90mm; OVAL X=26, Y=33, H=50, 70, 90mm) and rings (17x22, 22x28, 26x33, H=4.8mm) and screws (M3x6.5). The range of dimensional characteristics is "identical" to the DePuy Motech Surgical Titanium Mesh.
Material Composition	Commercially pure titanium (ASTM F67) (Matching predicate device's material) and established biocompatibility.	Manufactured from commercially pure titanium (ASTM F67). Material composition is "identical" to the DePuy Motech Surgical Titanium Mesh. CP Titanium is an "established biocompatible material."
Mechanical Characteristics	Hole to metal ratio and overall mechanical characteristics within the range of the predicate device.	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."
Sterilization	Compatibility with a recommended sterilization method for non-sterile devices.	Provided non-sterile; moist heat sterilization is recommended. (This would be expected to be consistent with practices for titanium implants).

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. This submission relies on demonstrating substantial equivalence to a predicate device, rather than performing an independent clinical or bench performance test with a specific sample size. The "test set" effectively refers to the predicate device's established performance.
Data Provenance: Not applicable for a new, independent test set. The data provenance is from the previously cleared DePuy Motech Surgical Titanium Mesh (K900138), which would have had its own supporting data at the time of its clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No "ground truth" was established for a new test set in this 510(k) submission. The FDA's review process relied on the existing clearance of the predicate device and the presented comparative data.

4. Adjudication Method for the Test Set

Not applicable. There was no independent test set requiring adjudication in this substantial equivalence submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is typically for evaluating diagnostic or interpretive devices involving human readers. The SYNTHES SynMesh is a surgical implant; therefore, an MRMC study is not relevant to its clearance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is not an algorithm or AI-based system. It's a physical medical device.

7. The Type of Ground Truth Used

The "ground truth," in the context of a substantial equivalence submission for a physical implant, is the established safety and effectiveness profile of the predicate device, based on its prior clearance and clinical use. No new "ground truth" was generated.

8. The Sample Size for the Training Set

Not applicable. This concept is relevant to machine learning algorithms, which are not involved in the clearance of the SYNTHES SynMesh.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

Summary of the "Study" Proving Acceptance Criteria:

The "study" in this context is a comparative analysis demonstrating that the SYNTHES SynMesh is substantially equivalent to the DePuy Motech Surgical Titanium Mesh (K900138). This involved showing:

Identical Indications for Use.
Identical Material Composition (commercially pure titanium, ASTM F67).
Identical Dimensional Characteristics (same range of flat mesh size, cylinder sizes, ring sizes, and screw definitions).
Mechanical Characteristics within Range: The hole-to-metal ratio, and thus the inferred mechanical characteristics, were shown to fall within the range of the predicate device.

The premise is that if the new device is functionally, materially, and dimensionally equivalent to a device already deemed safe and effective, then it is also safe and effective. The FDA's acceptance of this submission is based on this comparative rationale rather than a de novo clinical trial or performance study.

Summary

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K983766

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 dimensions of the flat mesh are 90 x 112mm. The preformed cylinders are:

TYPE	X(mm)	Y(mm)	HeightZ(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.

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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.

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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)

Over-the-Counter Use _

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983766

SynMesh 510(k)

Regulation Number and Section

§ 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.