5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235

K974847 · Arthrex, Inc. · MBI · Aug 6, 1998 · Orthopedic

Device Facts

• Record ID: K974847
• Device Name: 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Parachute Corkscrew Suture Anchor is intended for fixation of tissue 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 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

Device Story

Parachute Corkscrew Suture Anchor is a two-component orthopedic fixation device; consists of titanium alloy anchor and Poly (L-lactide) (PLA) disc connected by #4 non-absorbable braided polyester suture. Device is inserted through soft tissue into bone until apposition is achieved; disc design prevents anchor head from protruding above bone surface. Used by surgeons in clinical settings for various soft tissue-to-bone repairs across shoulder, foot/ankle, knee, hand/wrist, and elbow. Provides mechanical fixation to facilitate tissue healing.

Clinical Evidence

Bench testing only. Failure strength testing performed using 20 lb. density foam block to simulate poor quality bone. Results showed 40.98 lbs. failure strength.

Technological Characteristics

Anchor: Titanium 6Al-4V alloy (ASTM F136-96). Disc: Poly (L-lactide). Suture: #4 non-absorbable braided polyester. Insertion: Screw-in. Dimensions: 3.5mm or 5.0mm anchor with 8mm PLA disc.

Indications for Use

Indicated for fixation of soft tissue to bone in shoulder, foot/ankle, knee, hand/wrist, and elbow orthopedic repairs. Applicable to patients requiring ligament, tendon, or capsular reconstruction/repair.

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

• Arthrex FASTak
• Linvatec Bio-Anchor

Submission Summary (Full Text)

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AUG 6 1998

K974847

## 510(k) Summary

## 12/24/97

| 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 Parachute Corkscrew Suture Anchor |
| Common Name: | Suture Anchor |
| Classification: | Fastener, Fixation, Nondegradable, Soft Tissue (per 21 CFR 888.3030) |
| | Fastener, Fixation, Biodegradable, Soft Tissue |

### Description:

The Parachute Corkscrew Suture Anchor is a 2 component product consisting of a titanium alloy anchor with a PLA disc attached by a #4 non-absorbable braided polyester suture. Once the tissue is in the desired position, the Parachute Corkscrew is inserted through the tissue and into bone. The insertion is discontinued when the soft tissue/bone apposition has been achieved. The distance between the disk and anchor ensures that the head of the anchor is not protruding from the surface of the bone.

The anchor is made of Titanium 6AI-4V alloy (ASTM F136-96), the biocompatibility of which has been well documented. In regards to the material for the disc, Poly (L-lactide), it is currently being used in the Arthrex Bio-Interference Screw, which has received clearance for both bone and soft tissue fixation.

#### Intended Use:

The Parachute Corkscrew Suture Anchor is intended for fixation of tissue 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 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

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

# 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.

A substantial equivalence comparison is given in Table A. Although there are slight differences in design and failure strength between the various anchors, the critical value for the FASTak and Bio-Anchor is the tensile strength of the suture. Since the failure strength of the Parachute Corkscrew is greater than the knot tensile strength of size 2 suture (i.e. the maximum recommended size of suture for both the FAStak and the Bio-Anchor), none of the aforementioned differences make it any less safe and effective than the predicate devices. Furthermore, they do not raise any different questions regarding safety and effectiveness from the predicate devices.

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# Table A: Substantial

| Company | Device | Intended Use | Material |
|----------|------------------------|---------------------------------|--------------------------------------------------|
| Arthrex | Parachute<br>Corkscrew | Soft tissue to<br>bone fixation | Anchor: titanium a<br>Disc: Poly (L-lactic) acid |
| Arthrex | FASTak | Soft tissue to<br>bone fixation | Titanium Alloy |
| Linvatec | Bio-Anchor | Soft tissue to<br>bone fixation | Poly (L-lactic) acid |

* Testing performed using a 20 lb. density foam block to simulat
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# Equivalence Comparison

(

: 上一篇:

| | Size(s) | Insertion | Failure Strength |
|-------------|----------------------------------------------|-----------|----------------------------------------------------------------------|
| lloy<br>de) | 3.5mm w/8mm PLA disc<br>5.0mm w/8mm PLA disc | Screw in | 40.98 lbs.* |
| | 2.4mm w/#2 suture | Screw in | 55.40 lbs.* |
| ð | 3.5mm w/#0 to #2 suture | Impact | Diaphyseal: 33 lbs.**<br>Metaphyseal: 49 lbs.<br>Cancellous: 29 lbs. |

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract emblem featuring an eagle with its wings spread, with three human profiles incorporated into the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

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

K974847 Re: Arthrex Parachute Corkscrew Suture Anchor Trade Name: Requlatory Class: II Product Codes: MBI and GAT Dated: May 21, 1998 Received: June 2, 1998

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, 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 vour 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. ਖ 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 (QS) 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 - 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 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,

S. Curtis McWhirter, Ph.D., M.

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/6/Picture/0 description: The image shows the word "Arthrex" in bold, black letters. To the right of the word is a graphic of a surgical instrument, possibly scissors or forceps. The instrument is also in black and appears to be cutting or manipulating something.

# Indications for Use

The Parachute Corkscrew Suture Anchor is intended for fixation of tissue 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

**Prescription Use**
(Per 21 CFR 801.109)

signature

Sign-Off) (Division Pieneral Restore 510(k) Number .

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