CEMENT RESTRICTOR, SMALL AND LARGE

K021765 · Exactech, Inc. · JDK · Aug 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021765
• Device Name: CEMENT RESTRICTOR, SMALL AND LARGE
• Applicant: Exactech, Inc.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Aug 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tecres Cement Restrictor is inserted into the femoral medullary canal to limit the flow of bone cement and to aid in cement pressurization during primary or revision hip arthroplasty surgery.

Device Story

Single-component molded cement restrictor; used in femoral medullary canal during primary or revision hip arthroplasty. Positioned distal to prosthesis stem or centralizer using insertion instrument; prevents bone cement migration beyond proximal femoral canal; aids cement pressurization. Operated by orthopedic surgeons in OR. Available in small (12-18 mm) and large (18-24 mm) sizes. Provided in bone cement preparation kits or as standalone units with disposable ABS insertion instruments. Benefits patient by ensuring proper cement containment and fixation during hip replacement.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Radiolucent UHMWPE (ASTM F648-00, ISO 5834-1:1998, ISO 5834-2:1998). Insertion instrument: ABS. Sterilization: Gamma irradiation (SAL 10^-6). Form factor: Molded plug in two sizes (Small: 12-18mm, Large: 18-24mm).

Indications for Use

Indicated for blockage of femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty. Contraindicated for non-cemented procedures, spinal applications, patients with UHMWPE allergies, infectious arthritis, active joint infection, or neuromuscular compromise rendering surgery unjustifiable.

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

• Tornier Cement Restrictor (K001932)
• Orthoplug Hard Bone Plug (K955631)
• Orthoplug Soft Bone Plug (K955632)
• Allen Medullary Cement Plugs, Zimmer Poly Plug Medullary Plugs (K001733)
• Omniflex-C UHMPE Mid-Shaft Restrictor (K923616)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

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Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

| Phone: | (352) - 377 - 1140 |
|--------|--------------------|
| Fax: | (352) - 378 - 2617 |

FDA Establishment Numbers:

Applicant/Sponsor – Exactech # 1038671 Manufacturer – Tecres #1526534

- Gary J. Miller, PH.D. Contact: Executive Vice President of Research & Development Exactech, Inc.
- Date: May 24, 2002

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### 510(k) Summary of Safety and Effectiveness

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#### Classifications / Proprietary Names

| Classification Name: | Prosthesis, Hip, Cement Restrictor |
|----------------------------------|--------------------------------------------------------|
| Product Code: | JDK |
| C.F.R. Section: | 878.3300 |
| Device Class: | II |
| Classification Panel: | General and Plastic Surgery |
| Common Name(s): | Cement Restrictor, Cement Plug |
| Trade / Proprietary Model Names: | Cement Restrictor - Small<br>Cement Restrictor - Large |

### Legally Marketed Devices for Substantial Equivalence Comparison

The Tecres Cement Restrictor is substantially equivalent to the following legally marketed devices that were cleared for marketing via the premarket approval (510(k)) numbers listed below.

| Manufacturer | Model | Product Code | 510(k) Number |
|-----------------|----------------------------------------------------------------------|--------------|---------------|
| Tornier | Tornier Cement Restrictor | JDI | K001932 |
| Sunmed, Inc. | Orthoplug Hard Bone Plug | LZN | K955631 |
| Sunmed, Inc. | Orthoplug Soft Bone Plug | LZN | K955632 |
| Zimmer, Inc. | Allen Medullary Cement<br>Plugs, Zimmer Poly Plug<br>Medullary Plugs | JDI | K001733 |
| Osteonics Corp. | Omniflex-C UHMPE Mid-<br>Shaft Restrictor | JDK | K923616 |

### Device Description

The cement restrictor is a single, molded component intended to be used for blocking the diaphysis of the femoral canal. It is positioned a few centimeters distal to the distal tip of the prosthesis stem or the stem's centralizer to prevent migration of bone cement beyond the proximal zone of the femoral medullary canal. The cement restrictor is positioned with the aid of an insertion instrument.

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### 510(k) Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The restrictors are manufactured of radiolucent medical grade Ultra-High Molecular-Weight Polyethylene (UHMWPE) per ASTM standard F648-00, and ISO standards ISO 5834-1:1998 and ISO 5834-2:1998. They are manufactured in two sizes: "Small" and "Large." The small restrictors are to be used for femoral medullary canals ranging from 12 to 18 mm. The large restrictors are to be used for femoral medullary canals ranging from 18 to 24 mm.

One of each size restrictor is packaged in a bone cement preparation kit with other bone cement accessories, including:

- The cement restrictor inserter .
- A femoral canal brush .
- A femoral canal sponge ●
- A cement pressurizer, and ●
- Two curettes to aid in removal of excess bone cement. .

The kit's packaging consists of a two-tray system with Copolyester (PETG) blister packs and Tyvek lids.

An alternative packaging is available in which a single restrictor is loaded onto its disposable, medical-grade Acrylonitrile Butadiene Styrene (ABS) insertion instrument. This assembly is packaged in double pouch system consisting of a laminate of polyethylene and polyamide. The final packaging for this version consists of a cardboard box.

### Intended Use

The Tecres Cement Restrictor is inserted into the femoral medullary canal to limit the flow of bone cement and to aid in cement pressurization during primary or revision hip arthroplasty surgery.

### Indications

Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

### Contraindications

Tecres Cement Restrictors are contraindicated for non-cemented total hip procedures and for applications other than those which are indicated.

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# 510(k) Summary of Safety and Effectiveness

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Tecres Cement Restrictors are contraindicated in infectious arthritis and in active infection of the joint(s) to be replaced. Use of the cement restrictors is also contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.

The Tecres Cement Restrictors are NOT indicated for any spinal applications.

The Tecres Cement Restrictors are contraindicated for any patients exhibiting allergies to UHMWPE implant materials.

### Sterilization

Tecres Cement Restrictors, whether in the kit or pouch packaging, are sterilized by gamma ray irradiation to a Sterility Assurance Level (SAL) of 10 6.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2002

Gary J. Miller, Ph.D. Executive Vice President of Research and Deveopment Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K021765

Trade/Device Name: Tecres Cement Restrictors -- Small and Large Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: May 24, 2002 Received: May 29, 2002

Dear Dr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Gary J. Miller, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

b. Mark A. Mclennan

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

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K021765 510(k) Number:

Cement Restrictors Device Name:

Indications:

Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

#### Contraindications:

Tecres Cement Restrictors are contraindicated for non-cemented total hip procedures and for applications other than those which are indicated.

Tecres Cement Restrictors are contraindicated in infectious arthritis and in active infection of the joint(s) to be replaced. Use of the cement restrictors is also contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.

The Tecres Cement Restrictors are NOT indicated for any spinal applications.

The Tecres Cement Restrictors are contraindicated for any patients exhibiting allergies to UHMWPE implant materials.

Please do not witte below this line - use another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use

X

Over the Counter Use

Mark M. Melvern

General, Restorative Section 3 Page 1 of 1