FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)

K971723 · Arthrex, Inc. · MBI · Jul 30, 1997 · Orthopedic

Device Facts

• Record ID: K971723
• Device Name: FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FASTak Suture Anchor is intended for fixation of suture to bone. The 11.7mm FASTak is intended for the following uses: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction Pelvis: Bladder Neck Suspension for female unnary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency The 7.5mm FASTak is intended for the same uses except Rotator Cuff Repair, Bankart Repair, and SLAP Lesion Repair

Device Story

Threaded suture anchor with eyelet; secures suture to bone for soft tissue repair. Eliminates need for pre-drilling; single-motion insertion grasps tissue and anchors simultaneously. Used by surgeons in orthopedic and pelvic procedures. Pull-out strength exceeds tensile strength of attached suture (#2 for 11.7mm, size 0 for 7.5mm), ensuring suture failure occurs before anchor pull-out. Provides reproducible fixation; benefits patient through stable tissue-to-bone attachment.

Clinical Evidence

Bench testing only. Pull-out strength testing performed in cortical and cancellous bone models to compare against predicate devices. Results demonstrate pull-out strength of 90+ lbs (11.7mm) and 60+ lbs (7.5mm), exceeding tensile strength of specified sutures.

Technological Characteristics

Threaded suture anchor; Titanium 6Al-4V alloy (ASTM F136-92); 11.7mm and 7.5mm sizes; non-degradable; mechanical fixation.

Indications for Use

Indicated for fixation of suture to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvic surgeries (e.g., ligament/tendon repair, bladder neck suspension). Contraindicated in surgeries not listed, insufficient bone quality/quantity, foreign body sensitivity, active infection, inability to follow post-op restrictions, future pregnancy (pelvis), and renal insufficiency/upper urinary tract obstruction (pelvis).

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 GII
• Statak 3.5
• Questus 3.5
• Mainstay 3.5
• PeBA C
• Statak 2.5
• Questus 2.5
• Mainstay 2.7

Submission Summary (Full Text)

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JUL 30 1997

## 510(k) Summary

5/7/97

| Company: | Arthrex, Inc. |
|----------|---------------------------------------------------------------------------------------|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Scott M. Durlacher<br>Director of Regulatory Affairs and Quality Assurance (ext. 117) |

| Trade Name: | Arthrex FASTak Suture Anchor |
|-----------------|----------------------------------------------------------------------|
| Common Name: | Suture Anchor |
| Classification: | Fastener, Fixation, Nondegradable, Soft Tissue (per 21 CFR 888.3040) |

# Description:

The FASTak is a threaded anchor with an eyelet for holding suture. The largest suture size used with the 11.7mm FASTak is a single strand of #2. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of #2 suture (~ 15 lbs.). The pull-out strength of the FASTak in cortical bone, as well as cancellous, is at least 90 Ibs. and thus provides an acceptable factor of safety.

The largest suture size used with the 7.5mm FASTak is a single strand of size 0. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of size 0 suture (~ 10 lbs.). The pull-out strength of the FASTak in cortical bone as well as cancellous is at least 60 lbs. and thus provides an acceptable factor of safety.

In addition to fulfilling the requirements of a suture anchor, the FASTak eliminates the need for predilling. In a single motion, the tissue is grasped, shifted and the FASTak inserted. The result is a technique which is both easier and more reproducible.

The FASTak is made of Titanium 6Al-4V alloy (ASTM F136-92). The biocompatibility of this alloy has been well documented.

## Intended Use:

The FASTak Suture Anchor is intended for fixation of suture to bone. The 11.7mm FASTak is intended for the following uses:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

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Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck Suspension for female unnary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency

The 7.5mm FASTak is intended for the same uses except Rotator Cuff Repair, Bankart Repair, and SLAP Lesion Repair

# Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device. Although there are slight differences in design and pullout strength between the various anchors, the critical value is the tensile strength of the suture. Since the pull-out strength of the FASTak is greater than the tensile strength of the supplied suture, the suture will clearly fail prior to the anchor pulling out.

| Product | Indications | Pull-Out (lbs.)* | | Suture Size |
|-----------------|-------------|------------------|----------|-------------|
| | | Cancellous | Cortical | |
| FASTak (11.7mm) | same | 95 | 91 | 2 |
| Mitek GII | same | 105** | 43** | 2 |
| Statak 3.5 | same | 100 | 30 | 2 |
| Questus 3.5 | same | 95 | 104 | 0, 2 |
| Mainstay 3.5 | same | unknown | unknown | 0 |
| PeBA C | same | 129 | 143 | unknown |
| FASTak (7.5mm) | same | 71 *** | 68 *** | 0 |
| Statak 2.5 | same | 65 | 37 | 0 |
| Questus 2.5 | same | 35 | unknown | 2-0, 0, 2 |
| Mainstay 2.7 | same | unknown | unknown | 2-0 |

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### Contraindications

- 1. Surgeries other than those indicated.
- 2. Insufficient quantity or quality of bone.
- 3. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
- 4. Active infection.
- 5. Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- 6. Pelvis: patients planning future pregnancies.
- 7. Pelyis: renal insufficiency and upper urinary tract relative obstruction.

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Image /page/3/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human form, with three faces in profile, overlaid on top of each other. The graphic is surrounded by a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott M. Durlacher Director of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104

JUL 3 0 1997

Re : K971723 FASTak Suture Anchor Requlatory Class: II Product Code: MBI Dated: May 7, 1997 Received: May 9, 1997

Dear Mr. Durlacher:

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, Druq, 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 Requlations. 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. Please note: concerning your device in the Federal Reqister. 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. Scott M. Durlacher

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 requlation (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.

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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Image /page/5/Picture/4 description: The image shows the word "Arthrex" in a bold, sans-serif font. To the right of the word, there is a stylized graphic of a surgical instrument, possibly a type of forceps or clamp. The instrument is depicted in a simplified, almost cartoonish manner, with circular handles and a hinge mechanism.

K971723

#### Indications for Use

The FASTak Suture Anchor (11.7mm) is intended for fixation of suture to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency

The FASTak Suture Anchor (7.5mm) is intended for fixation of suture to bone. This product is intended for the following indications:

Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulmar or Radial Collateral Ligamant Reconstruction

Peivis: Bladder Neck Suspension for female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency

to colufo

(Division Sign-Off) Division of Cieneral Restora 510(к; Number

PRESCRIPTION USE: X