(82 days)
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
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.
Here's an analysis of the provided 510(k) summary regarding the Arthrex FASTak Suture Anchor, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance (FASTak 11.7mm) | Reported Device Performance (FASTak 7.5mm) |
|---|---|---|---|
| Pull-out Strength (Cortical Bone) | > 15 lbs (tensile strength of #2 suture) | 91 lbs | 68 lbs |
| Pull-out Strength (Cancellous Bone) | > 15 lbs (tensile strength of #2 suture) | 95 lbs | 71 lbs |
| Factor of Safety | Acceptable (pull-out strength > suture tensile strength) | At least 90 lbs (vs ~15 lbs suture strength) | At least 60 lbs (vs ~10 lbs suture strength) |
| Elimination of Predrilling | Device eliminates need for predrilling | Eliminates need for predrilling | Eliminates need for predrilling |
| Biocompatibility | Made of biocompatible material | Titanium 6Al-4V alloy (ASTM F136-92) - well documented biocompatibility | Titanium 6Al-4V alloy (ASTM F136-92) - well documented biocompatibility |
Study Proving Device Meets Acceptance Criteria:
The document describes material and mechanical testing performed on the FASTak Suture Anchor. The study's objective was to demonstrate that the pull-out strength of the FASTak anchor in both cortical and cancellous bone exceeds the tensile strength of the suture it is designed to hold, thus providing an "acceptable factor of safety."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size (e.g., number of anchors tested) for the pull-out strength tests. It provides average or minimum "at least" pull-out strength values.
- Data Provenance: The document implies laboratory testing (mechanical and material characterization). There is no information provided about the country of origin of the data or whether it was retrospective or prospective. It is assumed to be prospective, specifically designed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is objective physical properties (pull-out strength, material composition) determined through mechanical and material science testing, not through expert interpretation of biological data.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the assessment is based on objective physical measurements, not on expert consensus or adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The device is a physical surgical implant (suture anchor), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating compliance with acceptance criteria is:
- Mechanical Testing Results: Direct measurements of pull-out strength using laboratory-controlled tests.
- Material Characterization: Verification of the device's material composition against established standards (Titanium 6Al-4V alloy, ASTM F136-92).
- Suture Tensile Strength: Known industry standards for the tensile strength of specific suture sizes.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set, there is no ground truth for it to be established.
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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: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Scott M. DurlacherDirector 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
-
- Surgeries other than those indicated.
-
- Insufficient quantity or quality of bone.
-
- Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
-
- Active infection.
-
- Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
-
- Pelvis: patients planning future pregnancies.
-
- 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.