CEMSTOP CEMENT RESTRICTOR

K993841 · Encore Orthopedics, Inc. · LZN · May 4, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K993841
• Device Name: CEMSTOP CEMENT RESTRICTOR
• Applicant: Encore Orthopedics, Inc.
• Product Code: LZN · General, Plastic Surgery
• Decision Date: May 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation.

Device Story

CEMSTOP Cement Restrictor is a diaphyseal plug used during total hip arthroplasty. Device is inserted into the medullary cavity to occlude the space before introduction of acrylic bone cement. By preventing cement from flowing down the diaphysis, the device facilitates cement pressurization. The device is biocompatible, resorbs within several days at 37°C, and resists temperature increases caused by acrylic cement polymerization. Available in diameters ranging from 6mm to 20mm. Used by orthopedic surgeons in the operating room.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material comparison to the predicate device.

Technological Characteristics

Diaphyseal plug available in 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, and 20mm diameters. Material is biocompatible and resorbable at 37°C. Designed to withstand heat generated by acrylic cement polymerization.

Indications for Use

Indicated for use as a diaphyseal plug to occlude the medullary cavity during total hip arthroplasty to facilitate cement pressurization.

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.

Predicate Devices

• BIOSTOP G Cement Restrictor (Landos, Inc.)

Submission Summary (Full Text)

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# MAY = 4 2000

K 993841

## 510(k) Summary of Safety and Effectiveness

- (1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin. TX 78758 512) 834-6237 Debbie De Los Santos November 3, 1999

- Trade or proprietary device name: CEMSTOP Cement Restrictor (2) Common or usual name: Cement restrictor Class II Classification name:
- Legally marketed predicate device: BIOSTOP G Cement Restrictor (Landos, Inc.) (3)

### (4) Subject device description:

The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement.

The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.

### (ર) Subject device intended use:

The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation.

### (6) Technological characteristics:

The CEMSTOP cement restrictor has the same technological characteristics (i.e., design and material) when compared to the predicate devices.

### (7) Basis for substantial equivalence:

Features comparable to predicate devices include material, design and indications.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a series of flowing lines, possibly representing human profiles. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2000

Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore 9800 Metric Boulevard Austin, Texas 78758

Re: K993841 Trade Name: CEMSTOP Cement Restictor Regulatory Class: II Product Code: LZN Dated: March 3, 2000 Received: March 6, 2000

Dear Ms. De Los Santos:

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 control provisions of the Act. The general control 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 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.

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 - Ms. Debbie De Los Santos

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific an invitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 1010-11-21 questions on the promotion and advertising of your device, [phone]. Truuntonally, 101 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 monifacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Donne R. Kirchner

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

CEMSTOP Cement Restrictor_ Device Name: _

Indications For Use:

## CEMSTOP Cement Restrictor Indications For Use

The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medulary carity The CEMS I OF cement restrictor is a diaplyson progetting arthroplasty. The CEMSTOP restrictor before the introduction of acryne commit daring tour any would be facilitates cement pressurisation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96)_

Dmn R. Lochner.

(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices S10(k) Number L99384