TALON ANCHOR SNAP-PAK

K993261 · Mitek Products · MBI · Dec 2, 1999 · Orthopedic

Device Facts

• Record ID: K993261
• Device Name: TALON ANCHOR SNAP-PAK
• Applicant: Mitek Products
• Product Code: MBI · Orthopedic
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications: - Repair/reconstruction of collateral ligaments, Flexor and Extensor Hand: tendons at the PIP (Proximal Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal Interphalangeal) joints for all digits. - Repair/reconstruction of ligaments and tendons on the dorsal and Wrist: volar aspects of the carpal bones.

Device Story

Sterile implant device used to anchor or lock suture within pre-drilled bone sites; secures soft tissue to bone. Used in orthopedic surgical procedures for hand and wrist ligament/tendon repair. Operated by surgeons in clinical settings. Device provides mechanical fixation of suture to bone, facilitating tissue healing. Benefits include stable attachment of soft tissue to bone during reconstruction.

Clinical Evidence

Bench testing only. Performance evaluated via pull-out force testing using preserved human cadaver hand and wrist specimens to compare strength against the predicate Mitek Micro Anchor.

Technological Characteristics

Sterile bone fixation anchor. Mechanical device for suture anchoring. Materials and sterilization methods are consistent with predicate devices.

Indications for Use

Indicated for patients requiring fixation of non-absorbable braided surgical suture to bone for repair/reconstruction of collateral ligaments, flexor and extensor tendons at PIP, DIP, and MCP joints of all digits, and ligaments/tendons on dorsal and volar aspects of carpal bones.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Mitek LS Anchor (K931782)
• Mitek Micro Anchor (K962511)
• Mitek Micro Anchor (K982420)

Submission Summary (Full Text)

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DEC - 2 1999

Mitek Products TALONTM Anchor Snap-Pak 510(k) Premarket Notifi September 28, 1999

# 510(k) Summary

| Trade Name: | TALON™ Anchor Snap-Pak |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Mitek Products<br>60 Glacier Drive<br>Westwood, MA 02090<br>Registration #1221934 |
| Contact: | Paula E. Bulger<br>Regulatory Affairs Project Manager<br>Mitek Products<br>60 Glacier Drive<br>Westwood, MA 02090<br>Phone: [phone]<br>Fax: [phone] |
| Device Generic Name: | Staple, Fixation, Bone |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Product Code: | JDR (21 CFR 888.3030) |
| Predicate Devices: | K931782 - Mitek LS Anchor<br>K962511, K982420 - Mitek Micro Anchor |

Product Description: The device described in this 510(k) is a sterile implant used to anchor or lock suture within pre-drilled bone sites and firmly secure soft tissue to bone.

## Indications for Use:

The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications:

- Repair/recosntruction of collateral ligaments, Flexor and Extension tendons at the PIP (Proximalo Hand: Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal interphalangeal) joints for all digits.
- Repair/reconstruction of ligaments and tendons on the dorsal and volar aspects of the carpal bones. Wrist:

#### Safety and Performance:

The following safety and performance data has been provided to support substantial equivalence of TALONTM Anchor Snap-Pak:

Performance testing: Pull-out force (preserved human cadaver hand and wrist) Strength comparison (TALON vs. Mitek Micro Anchor)

### Conclusion:

Based on safety and performance data, similarities in design, operating principle, materials, biocompatibility and sterilization method, the TALON™ Anchor Snap-Pak has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Ms. Cynthia A. Sinclair Requlatory Consultant Mitek Products 60 Glacier Drive 02090 Westwood, Massachusetts

Re: K993261 TALON™ Anchor Snap-Pak Regulatory Class: II Product Codes: MBI and GAT Dated: September 28, 1999 September 29, 1999 Received:

Dear Ms. Sinclair:

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 The general controls provisions of the Act 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 requlation (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 In addition, FDA may publish further announcements action. 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 requlations.

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# Page 2 - Ms. Cynthia A. Sinclair

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,

Neil RP Ogden
James E. Dillard III for

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Mitek Products TALONTM Anchor Snap-Pak 510(k) Premarket Notification September 28, 1999

Page __ 1___ of ___ 1___

510(k) Number (if known): ا

Device Name: ___TALON™ Anchor Snap-Pak_

Indications for Use:

The TALON™ Anchor Snap-Pak is used for the fixation of non-absorbable braided surgical suture to bone. This product is intended for the following indications:

- Repair/reconstruction of collateral ligaments, Flexor and Extensor Hand: tendons at the PIP (Proximal Interphalangeal), DIP (Distal Interphalangeal) and MCP (Metacarpal Interphalangeal) joints for all digits.
- Repair/reconstruction of ligaments and tendons on the dorsal and Wrist: volar aspects of the carpal bones.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | NRO |
|---------------------------------|---------|
| Division of General Restorative | |
| 510(k) Number | K993261 |

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-the-Counter Use | |
|----------------------|--|
|----------------------|--|