SYNTHES (USA) TITANIUM WIRE

K041333 · Synthes (Usa) · GAQ · Aug 27, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041333
• Device Name: SYNTHES (USA) TITANIUM WIRE
• Applicant: Synthes (Usa)
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.

Device Story

Synthes Titanium Wire is a sterile, nonabsorbable, monofilament surgical wire composed of Commercially Pure (CP) Titanium. Available in 500mm lengths with various gauge sizes (26, 28, 30, 32), it may be supplied with or without a permanently attached stainless steel needle. Used by surgeons in clinical settings for soft tissue approximation and ligation, specifically for ophthalmic procedures like canthoplasty, canthopexy, and canthal tendon repair. The device functions as a mechanical suture to hold tissue in place during healing. It provides a biocompatible alternative to traditional nylon sutures, offering mechanical stability for soft tissue repair.

Clinical Evidence

Bench testing only. Testing conducted according to United States Pharmacopeia (U.S.P.) methods for titanium wire with and without needle. Results demonstrated that the device met USP standards for length, tensile strength, and needle attachment strength, confirming technical equivalence to the predicate.

Technological Characteristics

Material: Commercially Pure (CP) Titanium (ASTM F-1341). Form: Monofilament wire, 500mm length, gauges 26-32. Features: Sterile, single-use, optional stainless steel needle. No software or electronic components.

Indications for Use

Indicated for soft tissue approximation and/or ligation, including canthoplasty, canthopexy, and canthal tendon repair in patients requiring surgical suture.

Regulatory Classification

Identification

A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

Special Controls

*Classification.* Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Ethicon Inc.: Ethilon™ Nylon Sutures

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness Information [510(k) Summary] 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) Titanium Wire |
| CLASSIFICATION: | Class II § 21 CFR 878.4495: Stainless Steel |
| PREDICATE DEVICE: | Ethicon Inc .: Ethilon™ Nylon Sutures |
| DEVICE DESCRIPTION: | The Synthes Titanium Wire is a nonabsorbable, monofilament,<br>sterile surgical wire composed of Commercially Pure Titanium The<br>titanium wire is available in a length of 500mm with different gauge sizes<br>and is available with or without a permanently attached stainless steel<br>needle. |
| INTENDED USE: | Synthes (USA) Titanium Wire is indicated for use in soft tissue<br>approximation and/or ligation, for canthoplasty, canthopexy and/or canthal<br>tendon repair. |
| SUBSTANTIAL<br>EQUIVALENCE: | Comparative information presented supports substantial equivalence.<br>The term "substantial equivalence" as used in this 510(k) notification is<br>limited to the definition of substantial equivalence found in the Federal<br>Food, Drug and Cosmetic Act, as amended and as applied under 21CFR<br>807, Subpart E under which a device can be marketed without premarket<br>approval or reclassification. A determination of substantial equivalency<br>under this notification is not intended to have any bearing whatsoever on<br>the resolution of patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence herein shall be<br>construed as an admission against interest under the US Patent Laws or<br>their application by the courts. |

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K041333

#### 4.0 Device Name

Synthes (USA) [Synthes] Titanium Wire

#### Establishment Registration 5.0

The devices subject to this Pre-market Notification will be distributed by Synthes (USA), 1101 Synthes Avenue, Monument, CO 80312 (FDA Registration No. 1719045) and manufactured by Unique Instruments, Inc. 6688 Dixie Highway, Bridgeport, MI 48722 (FDA Registration No. 1828288).

#### Classification Information 6.0

The classification of the Synthes Titanium Wire has been determined to be Class II, as per Title 21 of the Code of Federal Regulations, section : 878.5020: Suture, Nonabsorbable, Synthetic, Polyamide.

#### Information Relating to Performance Standards and Special Controls 7.0

The material used in the manufacture of the Synthes Titanium Wire is Commercially Pure (CP) Titanium, which adheres to American Society for Testing and Materials (ASTM) standards [F-1341]

#### Sterilization Information 8.0

Synthes will provide these devices STERILE. Information supporting the sterile device can be found in Attachment 1. These devices are for single use only.

#### Description of the Device 9.0

The Synthes Titanium Wire is a non-absorbable, monofilament, sterile surgical wire composed of Commercially Pure Titanium wire is available in a length of 500mm with different gauge sizes (26, 28, 30, 32) and is available with or without a permanently attached stainless steel needle.

Confidential engineering drawings can be found in Attachment II.

#### 10.0 Proposed Labels/Labeling

Please sec Attachment III.

#### Commercially Available Device Information 11.0

The predicate device, Ethilon Nylon Suture, has been cleared for commercial distribution via the premarket notification process. Information on the predicate device can be found in Attachment IV.

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K041333

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### 12.0 Comparison to Commercially Available Device(s)

A comparison of the Synthes Titanium Wire to the predicate Ethilon™ Nylon Suture is below:

| New Device<br>Synthes Titanium Wire | Predicate Device<br>Ethicon, Inc.<br>Ethilon™ Nylon Suture<br>510(k) Unknown |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications:<br>Synthes (USA) Titanium Wire is<br>indicated for use in general soft tissue<br>approximation and /or ligation, including<br>use in ophthalmic procedures,such as<br>canthoplasty. | Indications:<br>ETHILON suture is indicated for use in<br>general soft tissue approximation, and / or<br>ligation, including use in cardiovascular,<br>ophthalmic and neurological procedures. |
| Design Features:<br>• Monofilament<br>• Sterile<br>• Nonabsorbable<br>• Available with or without<br>needle | Design Features:<br>• Monofilament<br>• Sterile<br>• Nonabsorbable<br>• Available with or without<br>needle |
| Dimensions (mm):<br>Sizes:<br>• Diameter: 0.20, 0.25, 0.31, 0.40<br>(26, 28, 30 & 32 gauge)<br>• Length: 500 | Dimensions (mm):<br>Sizes:<br>• Diameter: 0.01 - 0.5<br>• Length: Various |
| Material:<br>Titanium | Material:<br>Nylon |

## Device Comparison Chart

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# KD41333

### Determination of Substantial Equivalence: (ref. Office of Device Evaluation (ODE) Blue 13.0 Book Memorandum #86-3, Attachment I "510(k) "Substantial Equivalence" Decision-Making Process (Detailed)" |

New Device [Synthes (USA) Titanium Wire] is Compared to Marketed Device [Ethicon: Ethilon Nylon Suturel.

Does New Device Have Same Indication Statements? Essentially yes. Both devices are indicated for soft tissue approximation and/or ligation: however the Titanium Wire has a more specific indication to include canthoplasty.

## New Device Has Same Intended Use and May be "Substantially Equivalent".

Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.? Design: Yes. The design of the Titanium Wire is similar to the predicate device in that it is a nonabsorbable, monofilament wire which is available in a range of diameters/gauge sizes with or without attached needle. The subject device is 500 mm in length and provided sterile only.

Materials: No. The Synthes Titanium Wire is manufactured from CP Titanium where as, the predicate device is manufactured from Nylon.

## Could the New Characteristics Affect Safety or Effectiveness? No.

To establish the technical equivalency of the Synthes Titanium Wire to the predicate device, tests according to mcthods presented in United States Pharmacopia (U.S.P.) were conducted for titanium wire with and without needle. The test results show that the Synthes titanium wire tested met USP standards for length, tensile strength, and needle attachment strength, not diameter, and are technically equivalent to the predicate device tested. Please see the attached mechanical test summary, which can be found in Attachment V.

#### 14.0 Confidentiality Certification

We consider our intent to market this device to be confidential commercial information. Synthes has not disclosed the intent to market this product to others who are not collaborators and consultants. We have taken caution to protect the confidentiality of our intent.

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Image /page/4/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized emblem, consisting of three overlapping, curved shapes that resemble a human form or a symbol representing health and well-being.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 2004

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K041333

Trade/Device Name: Synthes (USA) Titanium Wire Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: July 26, 2004 Received: July 27, 2004

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your be determined the device is substantially equivalent (for the indications forcrenced above and norsure) to legally marketed predicate devices marketed in interstate for ass stated in the encreased 9776, 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). and Oosmeter fore, market the device, subject to the general controls provisions of the Act. The r ou may, chere, many 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 (PMA), it 11 your de subject to such additional controls. Existing major regulations affecting your device can may or subject to de 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 or any I odotar states and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 2.0 Indications for Use Statement

Page _ 1 of __ 1 __ 1

1999 1992 11

| 510(k) Number (if known): | k041333 |
|---------------------------|---------|
|---------------------------|---------|

Synthes (USA) Titanium Wire Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications:

Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.

X x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Pcr 21 CFR 801.109)

ાર

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Musiam C. Provost

(Division Sign-Off) Division of General, Restoration, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________