TFCC FAST-FIX KIT

K132079 · Smith & Nephew, Inc. · GAT · Dec 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132079
• Device Name: TFCC FAST-FIX KIT
• Applicant: Smith & Nephew, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Dec 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Smith & Nephew TFCC FAST-FIX Kit is intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

Device Story

TFCC FAST-FIX Kit is an all-inside repair system for Triangular Fibrocartilage Complex (TFCC) injuries. System comprises a delivery device pre-assembled with a disposable split cannula, plus a knot pusher/suture cutter. Delivery device contains two PEEK implants pre-tied with #2-0 UHMWPE suture, preloaded into a needle delivery system. Used by surgeons in clinical settings to facilitate TFCC repair. Surgeon deploys implants through the needle delivery system; suture is tightened using the knot pusher to secure the tissue. Device provides mechanical fixation of the TFCC, aiding in tissue healing and stabilization. Single-use, sterile device.

Clinical Evidence

Bench testing only. Mechanical testing, including ultimate tensile strength and load at 2mm elongation, demonstrated performance equivalent to predicate devices. No clinical data required.

Technological Characteristics

Materials: PEEK implants, UHMWPE suture, stainless steel needle, Pebax depth limiter, Nylon 101 suture retaining tube. Principle: Suture retention/fixation. Form factor: Needle delivery system with split cannula. Sterilization: 100% EtO (SAL 10-5). Single-use.

Indications for Use

Indicated for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures in patients requiring such surgical intervention.

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

• FAST-FIX 360 Meniscal Repair System (K092508)
• ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems (K072322)

Submission Summary (Full Text)

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# Smith & Nephew TFCC FAST-FIX Kit 510(k) Summary of Safety and Effectiveness

### Date prepared: November 13, 2013

| Submitter Information | Contact Information |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Smith & Nephew, Inc., Endoscopy Division<br>150 Minuteman Road<br>Andover, MA 01810 | Jason Sells<br>Group Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |

| Device Name (Unmodified) | |
|---------------------------|------------------------------------------------------------------|
| Trade or proprietary name | TFCC FAST-FIX Kit |
| Common or usual name | Suture retention device |
| Classification name | 21 CFR §878.5000 Suture, Non-absorbable, Synthetic, Polyethylene |
| Product code | GAT |

# Legally Marketed Predicate Device

The Smith & Nephew TFCC FAST-FIX Kit is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:

- K092508 FAST-FIX 360 Meniscal Repair System (Cleared January 28, 2012)
- K072322 ULTRA FAST-FIX and ULTRA FAST-FIX AB Meniscal Repair Systems (Cleared September 18, 2007)

# Device Description

The TFCC FAST-FIX Kit is an all-inside Triangular Fibrocartilage Complex (TFCC) repair system. The kit consists of the delivery device pre-assembled with a disposable split cannula and also packaged with a knot pusher/ suture cutter. The delivery device includes two non-absorbable polymer implants (Polyetheretherketone (PEEK)), pre-tied with #2-0 non-absorbable suture (Ultra High Molecular Weight Polyethylene (UHMWPE)) and preloaded into a needle delivery system.

#### Indications For Use

The Smith & Nephew TFCC FAST-FIX Kit is intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

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# Technological Characteristics

ﺗﺮ

The Smith & Nephew TFCC FAST-FIX Kit is substantially equivalent in design and fundamental scientific technology to the defined predicate devices and raise no new issues of safety and efficacy. Further detail is provided in the table below.

| | FAST-FIX 360<br>(Predicate Device) | TFCC FAST-FIX Kit<br>(Subject Device) |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K092508 | K132079 |
| Description | The FAST-FIX 360 Meniscal Repair System is<br>an all-inside meniscal repair device. Each<br>device includes two non-absorbable polymer<br>implants, pre-tied with #2-0 non-absorbable<br>suture and preloaded into a needle delivery<br>system. The adjustable depth penetration<br>limiter is preset to approximately 18 mm from<br>the tip of the needle. It can be adjusted down<br>in 2 mm increments to approximately 10 mm. | The TFCC FAST-FIX Kit is an all-inside TFCC<br>repair system. The kit consists of the delivery<br>device pre-assembled with a disposable split<br>cannula and also packaged with a Knot<br>pusher/ Suture cutter. The delivery device<br>includes two non-absorbable polymer<br>implants, pre-tied with #2-0 non-absorbable<br>suture and preloaded into a needle delivery<br>system |
| Implant Material | Polyetheretherketone (PEEK) | Same |
| T1 Implant<br>dimensions: | 0.200 x 0.040 inches | Same |
| T2 Implant<br>dimensions | 0.190 x 0.059 inches | Same |
| Suture | Ultra high molecular weight polyethylene<br>(UHMWPE) | Same |
| Suture Knot | Patented one-way self-locking sliding knot tied<br>with 2 suture retention bar implants | Same |
| Suture Size | #2-0 | Same |
| Delivery Needle | Stainless Steel | Same |
| Needle shaft OD | Outer Diameter 0.058" | Same |
| Depth Limiter<br>Tube | Pebax (White) | Same |
| Depth Limiter<br>Tube length | 5.399" | 3.94" |
| Suture<br>Retaining Tube | Nylon 101 | Same |
| Sterilization | 100% EtO (SAL 10-5) | Same |
| How provided | Sterile, Single Use Only | Same |
| Packaging<br>Configuration | Carton, Paper Carrier, Two pouches (inner<br>and outer) | Carton and Paper Carrier identical. One pouch only (same as inner pouch of predicate) Device has Split Cannula pre-assembled. There is additional pouch with Knot Pusher/Suture Cutter. |
| Shelf Life | 3 Years | Same |

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# Performance Data

Mechanical testing was conducted and the results were compared to the testing conducted on predicate devices. The Ultimate tensile strength tests and tests to determine load at 2mm elongation confirmed that the TFCC FAST-FIX construct is at least equivalent to the predicate devices and that there are no new issues related to safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject device.

## Conclusion

The subject TFCC FAST-FIX Kit may be considered substantially equivalent to the identified predicate devices based on similarities in design and indications for use. The results of mechanical testing performed on the subject device did not raise any new issues of safety or effectiveness, and the TFCC FAST-FIX Kit performed at least equivalent to the identified predicates.

ﺗ

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Incorporated Mr. Jason Sells Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

December 5, 2013

Re: K132079

Trade/Device Name: TFCC FAST-FIX Kit Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: November 14, 2013 Received: November 15, 2013

Dear Mr. Sells:

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. 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 11 (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 (reporting of medical

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Page 2 - Mr. Jason Sells

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(k) Number (if known): K132079

Device Name: TFCC FAST-FIX Kit

#### Indications for Use:

The Smith & Nephew TFCC FAST-FIX Kit is intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

. .

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132079

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