ROTORBLADE

K983435 · Li Medical Technologies, Inc. · MAI · Apr 29, 1999 · Orthopedic

Device Facts

• Record ID: K983435
• Device Name: ROTORBLADE
• Applicant: Li Medical Technologies, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Apr 29, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Shoulder - rotator cuff repair

Device Story

The Li Medical RotorBlade™ (LM Anchor) is a bone anchor device used for soft tissue to bone attachment during rotator cuff repair. It features a horizontal propeller blade design to achieve bony purchase. Suture is passed through the anchor to secure soft tissue. The device is intended for use by surgeons in a clinical setting.

Clinical Evidence

Bench testing only. Pre-clinical testing in cadaver specimens compared the mean pullout strength of the LM Anchor to the Mitek PanaLok™ RC, demonstrating substantial equivalence.

Technological Characteristics

Material: Surgical grade PLL (homopolymer poly(L(-)-lactide)). Design: Horizontal propeller blade type anchor. Function: Bone anchor for soft tissue to bone attachment.

Indications for Use

Indicated for rotator cuff repair in the shoulder.

Regulatory Classification

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.

Predicate Devices

• Mitek Surgical Products PanaLok™ RC (K950272)

Submission Summary (Full Text)

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4/29/99

Li Medical Technologies Inc. 4 Armstrong Road Shelton, Connecticut 06484 203-944-2800

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K9834-35

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Li Medical

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| Device Sponsor:<br>Contact:<br>Date: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,<br>203-944-2800<br>Rhodemann Li, Vice President<br>September 28, 1998 |
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| Classification Name:<br>Common Name:<br>Proprietary Name: | Unclassified<br>Bone anchor<br>Li Medical RotorBlade™ |
| Predicate Device: | Mitek Surgical Products PanaLok™ RC (K950272) |
| Device Description: | Made from surgical grade PLL (homopolymer poly<br>(L(-)-lactide), the LM Anchor is designed as a propeller blade<br>type anchor device through which suture is passed to provide a<br>means for soft tissue to bone attachment. |
| Intended Use: | Shoulder - rotator cuff repair |
| Technical Comparison: | The LM Anchor is similar to the Mitek anchors in its<br>intended use, however, the bony purchase is accomplished by<br>the LM Anchor through a horizontal propeller blade design<br>versus a tapered rod design with the Mitek anchors. |
| Performance Data: | Pre-clinical testing in cadaver specimen showed that the mean<br>pullout strength of the LM Anchor was substantially equivalent<br>to the mean pullout strength of the Mitek anchors. |

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510(K) SUMMARY

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Mr. Rhodemann Li Vice President Li Medical Technologies, Inc. 4 Armstrong Road Shelton, Connecticut 06484

K983435 Re: RotorBlade™ Suture Anchor Trade Name: Regulatory Class: II Product Codes: MAI and GAS Dated: February 2, 1999 February 4, 1999 Received:

Dear Mr. Li:

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 Quality System Requlation (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 requlation may result in requlatory 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. Rhodemann Li

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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known):

## K98, 3435

Device Name:

LM Anchor

Indications For Use: Shoulder: rotator cuff repair

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices

Division of General Restorative Devices
510(k) Number L983435

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use ___________

(Optional Format 1-2-96)