← Product Code [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI) · K990987

# BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B (K990987)

_Arthrex, Inc. · MAI · Jan 13, 2000 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K990987

## Device Facts

- **Applicant:** Arthrex, Inc.
- **Product Code:** [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI.md)
- **Decision Date:** Jan 13, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3030
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Bio-Absorbable Corkscrew Suture Anchor is intended for fixation of soft 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, Ultar or Radial Collateral Ligamant Reconstruction Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

## Device Story

Bio-Absorbable Corkscrew Suture Anchor; threaded design; manufactured from poly (L, DL-lactide); features two strands of #2 braided polyester suture insert-molded through center. Used by surgeons in clinical settings for soft tissue-to-bone reattachment. Procedure requires bone preparation with a tap; anchor seated via disposable driver. Suture ends used to secure tissue. Benefits include secure fixation using biodegradable material.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Material: poly (L, DL-lactide). Design: threaded suture anchor with hex head. Components: #2 braided polyester suture. Accessories: disposable driver, bone tap. Mechanical fixation principle.

## Regulatory Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Submission Summary (Full Text)

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K990987

JAN 1 3 2000

## 510(k) Summary

1052

## 01/12/00

| Company: | Arthrex, Inc.                             |
|----------|-------------------------------------------|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone:   | (941) 643-5553                            |
| Fax:     | (941) 643-6218                            |
| Contact: | Vernon C. Brown                           |
|          | Manager of Regulatory Affairs (ext. 117)  |

| Trade Name:     | Arthrex Bio-Absorbable Corkscrew Suture Anchor |
|-----------------|------------------------------------------------|
| Common Name:    | Suture Anchor                                  |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |

#### Description:

The Bio-Absorbable Corkscrew Suture Anchor is manufactured using poly (L, DL-lactide). It is a threaded design with two strands of #2 braided polyester suture insert molded through the center of the device. The anchor has a hex head, which is seated in a disposable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a tap. Once in place, the free ends of the suture are used to reattach soft tissue to the bone.

#### Intended Use:

The Bio-Absorbable Corkscrew Suture Anchor is intended for fixation of soft 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, Ultar or Radial Collateral Ligamant Reconstruction

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

# 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

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K990787 20
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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.

The differences between the Bio-Absorbable Corkscrew and the predicate devices cited do not raise any different questions regarding safety and effectiveness. Furthermore, the material is well characterized, and has been used in a predicate device with a similar indication. The device, as designed, is as safe and effective as the predicate devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or abstract human figure with three curved lines forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Mr. Vernon C. Brown Manager of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104

Re: K990987 Bio-Absorbable Corkscrew Regulatory Class: II Product Code: MAI and HWC Dated: October 11, 1999 Received: October 19, 1999

Dear Mr. Brown:

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 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.

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 Ouality System Regulation (OS) 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.

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.

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Page 2 - Mr. Vernon C. Brown

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 (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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Russell Sager

Gr James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K990987

# Indications for Use

The Bio-Absorbable Corkscrew 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 hypermobility or intrinsic sphincter deficiency

Neville Sawyer Sutor

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

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K990987](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K990987)

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