LM ANCHOR

K981764 · Li Medical Technologies, Inc. · MBI · Jul 13, 1998 · Orthopedic

Device Facts

• Record ID: K981764
• Device Name: LM ANCHOR
• Applicant: Li Medical Technologies, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 13, 1998
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Shoulder (bankart repair), Hand/Wrist (ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment), Skull (lateral canthoplasty), Foot/Ankle (hallux valgus reconstruction, midfoot reconstructions.

Device Story

LM Anchor; surgical grade 316L stainless steel bone anchor; features crown and center pin for suture passage; facilitates soft tissue to bone attachment. Used in orthopedic and reconstructive surgical procedures; operated by surgeons. Device provides mechanical fixation; bony purchase achieved via cantilevered beams. Benefits patient by securing soft tissue during ligament/tendon repair.

Clinical Evidence

Bench testing only. Pre-clinical pullout strength testing performed in cadaver specimens. Results showed mean pullout strength of the LM Anchor was substantially equivalent to or exceeded the mean pullout strength of the Mitek anchor.

Technological Characteristics

Material: 316L surgical grade stainless steel. Design: Cylindrical anchor with crown and center pin for suture passage. Fixation mechanism: Cantilevered beams. Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for soft tissue to bone attachment in shoulder (Bankart repair), hand/wrist (ligament/tendon reconstruction/reattachment), skull (lateral canthoplasty), and foot/ankle (hallux valgus/midfoot reconstruction) procedures.

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 Surgical Products Mini Anchor (K930892)

Submission Summary (Full Text)

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JUL 1 3 1998

## 510(K) SUMMARY

:

| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484,<br>203-944-2800 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Rhodemann Li, Vice President |
| Date: | May 18, 1998 |
| Classification Name: | Staple, Fixation, Bone |
| Common Name: | Bone anchor |
| Proprietary Name: | LM Anchor or other proprietary name |
| Predicate Device: | Mitek Surgical Products Mini Anchor (K930892) |
| Device Description: | Made from surgical grade stainless steel (316L), the<br>LM Anchor is designed with a crown and a center pin<br>through which suture is passed to provide a means for<br>soft tissue to bone attachment. |
| Intended Use: | Shoulder (bankart repair), Hand/Wrist (ulnar or lateral<br>collateral ligament reconstruction, scapholunate ligament<br>reconstruction, PIP collateral ligament, profundus tendon<br>reattachment), Skull (lateral canthoplasty), Foot/Ankle<br>(hallux valgus reconstruction, midfoot reconstructions. |
| Technical Comparison: | The LM Anchor is similar to the Mitek anchors in its<br>cylindrical shape, however, the bony purchase is<br>accomplished by the LM Anchor through cantilevered<br>beams versus nitinol arcs with the Mitek anchors. |
| Performance Data: | Pre-clinical testing in cadaver specimen showed that<br>the mean pullout strength of the LM Anchor was<br>substantially equivalent to or exceeded the mean pullout<br>strength of the Mitek anchor. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 1998

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

Re: K981764 Trade Name: LM Anchor Requlatory Class: II Product Codes: MBI, HWC, and GAT Dated: May 18, 1998 Received: May 19, 1998

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good 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 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 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.,

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

Enclosure

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510(k) Number (if known): K981764

LM Bone Anchor Device Name:

Indications For Use:

Shoulder - bankart repair

Hand/wrist - ulnar or lateral collateral ligament reconstruction, scapholunate ligament reconstruction, PIP collateral ligament, profundus tendon reattachment

Skull - lateral canthoplasty

Foot/ankle - hallux valgus reconstruction, midfoot reconstructions

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Concurrence of CDRH, Office of Device Evaluation (ODE)

pcoolo

(Divest Sign Off)
D general
510(k) number K9821764

Prescription Use X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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(Optional Format 1-2-96)

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