LINK CEMENT PLUG

K972411 · Turnkey Intergration USA, Inc. · LZN · Aug 29, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972411
• Device Name: LINK CEMENT PLUG
• Applicant: Turnkey Intergration USA, Inc.
• Product Code: LZN · General, Plastic Surgery
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Link femoral cement restrictor plug system is used to constrict the flow of bone cement (PMMA) into the distal section of the femoral canal during a cemented total hip arthoplasty.

Device Story

Link femoral cement restrictor plug system; used during cemented total hip arthroplasty. Device inserted into femoral canal to act as physical barrier; constricts flow of bone cement (PMMA) into distal section of canal. Operated by orthopedic surgeons in OR setting. Prevents distal migration of cement; ensures proper cement mantle formation around femoral implant stem. Benefits patient by optimizing cement distribution and fixation stability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Femoral cement restrictor plug; material: PMMA (bone cement) compatible; form factor: plug designed for femoral canal constriction; mechanical barrier principle.

Indications for Use

Indicated for use in patients undergoing cemented total hip arthroplasty to constrict bone cement (PMMA) flow into the distal femoral canal.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Douglas W. Stuart ·President Surgical Implants, Inc. -Representing Link America, Inc. 962 South Tamiami Trail, Suite 203 Sarasota, Florida 34326

AUG 29 1551

Re: K972411 Link, Cement Plug Requlatory Class: II Product Code: LZN Dated: June 13, 1997 Received: June 26, 1997

Dear Mr. Stuart:

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 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 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 requlations.

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## Page 2 - Mr. Douglas W. Stuarts

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 requlation 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 not known Femoral Cement Restrictor Plug System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## Statement of Intended Use

The Link femoral cement restrictor plug system is used to constrict the flow of bone cement (PMMA) into the distal section of the femoral canal during a cemented total hip arthoplasty.

Signed: DhStuart

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Divi.

Division of General Restorative Devices
510(k) Number K972441