COONRAD/MORREY ELBOW CEMENT RESTRICTOR

K040389 · Zimmer, Inc. · JDC · May 17, 2004 · Orthopedic

Device Facts

• Record ID: K040389
• Device Name: COONRAD/MORREY ELBOW CEMENT RESTRICTOR
• Applicant: Zimmer, Inc.
• Product Code: JDC · Orthopedic
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement. The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.

Device Story

Coonrad/Morrey Elbow Cement Restrictor is a polyethylene plug designed for total elbow arthroplasty. Device is inserted into the intramedullary canal prior to bone cement introduction and prosthesis insertion. Function is to impede distal flow of bone cement within the canal. Used by surgeons in clinical settings. Benefits include improved control of cement placement during joint replacement procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Molded polyethylene intramedullary plug. Designed for insertion into the intramedullary canal to restrict bone cement flow.

Indications for Use

Indicated for patients undergoing total joint arthroplasty requiring control, restriction, or impedance of bone cement flow within the intramedullary canal. Larger plugs are indicated for revision surgery involving wide, smooth intramedullary canals.

Regulatory Classification

Identification

An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,” (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Zimmer Allen Medullary Plugs (K001733)
• Zimmer Poly-Plug™ Intramedullary System (K950312)

Submission Summary (Full Text)

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# MAY 1 7 2004

## Summary of Safety and Effectiveness

:

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Noah J. Bartsch, MS<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | February 13, 2004 |
| Trade Name: | Coonrad/Morrey Elbow Cement Restrictor |
| Common Name: | Cement Obturator |
| Classification Name<br>and Reference: | Orthopaedic Surgical Mesh<br>21 CFR § 878.3300 |
| Predicate Devices: | Zimmer Allen Medullary Plugs, K001733, cleared<br>June 20, 2000.<br><br>Zimmer Poly-Plug™ Intramedullary System,<br>K950312, cleared May 17, 1995 |
| Device Description: | The Coonrad/Morrey Elbow Cement Restrictor is<br>designed to impede the flow of bone cement distal<br>to the prosthesis in the intramedullary canal during<br>total elbow arthroplasty. The plugs are molded<br>from polyethylene, and they are inserted into the<br>intramedullary canal prior to the introduction of<br>bone cement and insertion of the appropriate<br>prosthesis. |
| Intended Use: | Intramedullary cement plugs are indicated for use in<br>total joint arthroplasty to control, restrict or impede<br>the flow of cement.<br><br>The larger intramedullary cement plugs are useful<br>in revision surgery where a wide, smooth<br>intramedullary canal must be plugged. |
| Comparison to Predicate Device: | The Coonrad/Morrey Elbow Cement Restrictor is<br>equivalent to other commercially available<br>intramedullary cement plugs currently on the<br>market, by virtue of design and functionality. The<br>device has the same intended use as the predicate<br>devices, and has demonstrated the ability to<br>functionally perform the intended use. |
| Performance Data (Non-clinical): | Non-Clinical Performance and Conclusions: |
| | Non-clinical testing demonstrated that the<br>Coonrad/Morrey Elbow Cement Restrictor meets<br>performance requirements and is as safe and<br>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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2004

Noah J. Bartsch, MS Specialist, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Rc: K040389

Trade/Device Name: Coonrad/Morrey Elbow Cement Restrictor Regulation Number: 21 CFR 878.3150, 888.3160 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDC, JDB Dated: February 13, 2004 Received: February 17, 2004

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your became 910(t) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard want date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recalsmod in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciore, market the act include requirements for annual registration, listing of general controls provisions of the 120 labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aborve) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controllar Chile 21, Parts 800 to 898. In addition, FDA may be found in the Outs or enents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 177A s issuated of a backainments with other requirements of the Act
that FDA has made a determination that your device complies with other requirement that FDA has made a determination and Jointer Federal agencies. You must or any Federal statures and regulations damindiver, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as schoolenge CFR Part 807), fabening (21 CFRT at 001), good fif applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Noah J. Bartsch, MS

This letter will allow you to begin marketing your device as described in your Section 510(k) This icler with anow you to ogen maning of substantial equivalence of your device to a legally premailed notincation: The PDF intembly 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), please If you desire spoonly at [phone]. Also, please note the regulation entitled, Contact the Office of Compliance in (bet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millhussen

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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#### Indications for Use

### 510(k) Number (if known):

Device Name:

Coonrad/Morrey Elbow Cement Restrictor

#### Indications for Use:

Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement.

The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milleson

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K040384

0017