PRE-THREADED ENDOBUTTON

K984550 · Smith & Nephew, Inc. · GAT · Mar 1, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984550
• Device Name: PRE-THREADED ENDOBUTTON
• Applicant: Smith & Nephew, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pre-Threaded EndoButton is intended to be used to fixate suture during the repair of tendon and ligament fixation.

Device Story

Pre-Threaded EndoButton is a titanium suture retention device; pre-threaded with polyester tape and polyester suture; sterile, single-use. Used by surgeons during orthopedic reconstructive procedures, specifically ACL reconstruction, to fixate tendons and ligaments. Device functions as a mechanical anchor for soft tissue fixation. Benefits include simplified surgical workflow due to pre-threading, reducing intraoperative assembly time. Output is a secured tendon/ligament construct within the bone tunnel.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium and polyester. Form factor: Surgical button with pre-threaded tape/suture. Sterilization: Ethylene Oxide (EtO). Single-use. Mechanical fixation principle.

Indications for Use

Indicated for fixation of tendons and ligaments during orthopedic reconstructive procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). 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

• EndoButton (K933948)
• EndoButton Tape (K952535)
• EndoButton Continuous Loop (K980155)

Submission Summary (Full Text)

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# Section 6: 510(k) Summary of Safety and Effectiveness

| 6.1 | This summary of 510(k) safety and effectiveness information is being submitted in |
|-----------|-----------------------------------------------------------------------------------|
| Statement | accordance with the requirements of SMDA 1990 and CFR 807.92. |

| 6.2 | Smith & Nephew, Inc., Endoscopy Division |
|-----------|------------------------------------------|
| Submitter | 130 Forbes Blvd. |
| | Mansfield, Ma. 02048 |

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6.3 Susan Finneran Company Clinical/Regulatory Affairs Contact [phone]

| 6.4 | Proprietary Name: Pre-Threaded EndoButton |
|-------------|-------------------------------------------|
| Device Name | Common Name: Surgical Button |
| | Classification Name: Surgical Button |

| Predicate | EndoButton (K933948), EndoButton Tape (K952535), EndoButton Continuous |
|--------------------------------|------------------------------------------------------------------------|
| Legally<br>Marketed<br>Devices | Loop (K980155)<br>Smith and Nephew Endoscopy, Inc.<br>Mansfield, Ma. |

The Pre-Threaded EndoButton is a titanium suture retention device packaged ર્ભ રહ્યું હતું. સંદર્ભ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ sterile, pre-threaded with polyester tape and polyester suture. The construct is Device used to fixate tendons and ligaments during orthopedic procedures, specifically Description during ACL reconstructions.

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## 6.7

The Pre-Threaded EndoButton is intended to be used to fixate suture during the Intended Use repair of tendon and ligament fixation.

#### 6.8

Device The Pre-Threaded EndoButton is used for fixation of tendons and ligaments Indications during orthopedic reconstructive procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

| 6.9<br>Substantial<br>Equivalence | The Pre-Threaded EndoButton is substantially equivalent to the previously |
|-----------------------------------|----------------------------------------------------------------------------|
| | cleared EndoButton (K933948), the previously cleared EndoButton Tape |
| | (K952535), and the previously cleared EndoButton Continuous Loop (K980155) |

### Table of Substantial Equivalence

| Product<br>Name | Pre-Threaded<br>EndoButton | EndoButton | EndoButton<br>Tape | EndoButton<br>Continuous<br>Loop |
|-------------------------|---------------------------------|--------------------------------------|-----------------------------------------------------------|-------------------------------------|
| Product<br>Labeling | Sterile (EtO),<br>Single Use | Gamma<br>Irradiation , Single<br>Use | Ethylene Oxide,<br>Single Use | Gamma<br>Irradiation, Single<br>Use |
| Materials | polyester/titanium | titanium | polyester | polyester/titanium |
| Intended use | Soft tissue<br>fixation | Soft tissue fixation | For use with the<br>EndoButton in<br>soft tissue fixation | Soft Tissue<br>Fixation |
| Indications | Tendon and<br>Ligament Fixation | Tendon and<br>Ligament Fixation | Tendon and<br>Ligament Fixation | Tendon and<br>Ligament Fixation |
| Sterilization<br>Method | Ethylene Oxide | Gamma Irradiation | Ethylene Oxide | Gamma<br>Irradiation |

Applicant Les Jenn

Date 2/23/99

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 1999

Ms. Susan Finneran Clinical/Regulatory Associate Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield. Massachusetts 02048

Re: K984550 Trade Name: Pre-Threaded EndoButton Regulatory Class: II Product Code: GAT and MBI Dated: December 21, 1998 Received: December 22, 1998

Dear Ms. Finneran:

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 - Ms. Susan Finneran

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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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510 (k) Number (If Known):

Device Name: Pre-Threaded EndoButton

Indications For Use:

Indications For USe.
The Pre-Threaded EndoButton is used for fixation of tendons and ligaments during orthopedic The Fre-Tircaded EndoBatton is associety Cruciate Ligament (ACL) Reconstruction.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or Over-The-Counter Use

Pioledo

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