INTERBODY INNOVATIONS CEMENT RESTRICTOR

K051371 · Interbody Innovations, Llp · JDK · Dec 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051371
• Device Name: INTERBODY INNOVATIONS CEMENT RESTRICTOR
• Applicant: Interbody Innovations, Llp
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Dec 6, 2005
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictor is designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement. This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

Device Story

Hollow, curved, rectangular frame device; machined from PEEK-Optima; includes tantalum wire markers for radiographic visualization. Used in total hip or knee arthroplasty to occlude medullary canal prior to PMMA bone cement introduction. Operated by orthopedic surgeons in clinical settings. Device acts as physical barrier to prevent cement migration beyond desired site. Benefits include improved cement mantle containment and stability in joint replacement procedures.

Clinical Evidence

Bench testing only. Material biocompatibility certified to ISO 10993-1 requirements for implantable contact >30 days. No clinical data presented.

Technological Characteristics

Hollow curved rectangular frame; material: PEEK-Optima (ASTM F2026); markers: Tantalum wires (ASTM F560); non-sterile; intended for user sterilization; mechanical occlusion principle.

Indications for Use

Indicated for occlusion of the medullary canal prior to PMMA introduction during total hip or knee replacement. Contraindicated for spinal applications.

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

• Fortitude Cement Restrictor (K031837)
• FIDJI Large Cement Restrictor (K030871)
• RABEA Cement Restrictor (K020836)

Submission Summary (Full Text)

{0}------------------------------------------------

K051371 p/2

DEC 6 2005

Image /page/0/Picture/2 description: The image shows the logo for Interbody Innovations. The logo is black and white and features the company name in a bold, sans-serif font. The word "INTERBODY" is on the top line, and the word "INNOVATIONS" is on the bottom line. To the left of the text is a stylized "I" that is made up of three horizontal lines and two vertical lines.

## 510(k) Summary

#### Submitter Information:

Interbody Innovations 24 Smith Road, Suite 503 Midland, TX 79705

#### Contact:

Todd Stanaford Phone: [phone] Fax: [phone]

#### Date Prepared:

May 12, 2005

#### Product Name:

Classification Name: Surgical Mesh Trade Name(s): Interbody Innovations Cement Restrictor Panel: DCRND. Orthopedic Classification Regulation: 21 CFR 878.3300 Product Code: JDK

### Predicate Device:

This device is substantially equivalent to the following predicate devices:

#### Fortitude Cement Restrictor, marketed under K031837 FIDJI Large Cement Restrictor, marketed under K030871 RABEA Cement Restrictor, marketed under K020836

Interbody Innovations Cement Restrictors and predicated devices listed above, are devices that are used to occlude the medullary canal prior to the introduction of PMMA in total joint arthroplasty. None of the devices are intended for use in spine surgery. Technologically they are all virtually identical in their function and principle of operation.

#### Comparison to Predicates:

| PROPOSED<br>DEVICE | FORTITUDE<br>(K031837) | FIDJI (K030871) | RABEA<br>(K020836) |
|--------------------|------------------------|-----------------|--------------------|
|--------------------|------------------------|-----------------|--------------------|

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains a series of alphanumeric characters, seemingly handwritten. The characters appear to be "KOS 1371 1/2". The writing style is somewhat cursive, with some characters connected and others distinct.

| Intended<br>use | Occlusion of<br>medullar canal<br>prior to PMMA | Occlusion of<br>medullar canal<br>prior to PMMA | Occlusion of<br>medullar canal<br>prior to PMMA | Occlusion of<br>medullar canal<br>prior to PMMA |
|---------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|
| Anatomical<br>sites | Hip, knee | Hip, knee | Hip, knee | Hip, knee |
| Sterility | Nonsterile; to be<br>sterilized by<br>user | Nonsterile; to be<br>sterilized by<br>user | Nonsterile; to be<br>sterilized by user | Nonsterile; to be<br>sterilized by user |
| Material | PEEK-Optima<br>(ASTM F2026) | PEEK-Optima<br>(ASTM F2026) | PEEK-Optima<br>(ASTM F2026) | PEEK-Optima<br>(ASTM F2026) |
| Markers | Tantalum wires<br>(ASTM F560) | Tantalum wires<br>(ASTM F560) | Tantalum wires<br>(ASTM F560) | Tantalum wires<br>(ASTM F560) |

#### Description:

The Interbody Innovations Cement Restrictors is a hollow curved rectangular frame that is machined from extruded Polyetheretherketone (PEEK). It contains tantalum inserts that serve as location and orientation markers for radiographs. The device is intended to be used in conjunction with standard PMMA

#### Intended Use:

This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement.

This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

#### Performance Data:

This device is constructed of the same material (polyetheretherketone, or PEEK-Optima) as the predicate device(s). This material complies with ASTM F2026. The manufacturer of this material has an FDA Device Master File, and has certified biocompatibility to ISO 10993-1 requirements for implantable contact greater than 30 days.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a staff with three snakes entwined around it.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC & 2005

Interbody Innovations LLP c/o Mr. Ian P. Gordon Senior Vice President Emergo Group, Inc. 2454 McMullen Booth Road Suite 427 Clearwater, Florida 33759

Re: K051371

Trade/Device Name: Interbody Innovations Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: JDK Dated: September 15, 2005 Received: September 19, 2005

Dear Mr. Gordon:

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 for use surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to econments 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 and Cosment 100 (The Act and the limitations described below. The general controls provisions of the provisions of the Act annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Deed for an intended use not identified in the proposed labeling and that such use acould cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following United cause in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

Furthermore, the indication for use -- occlusion of the medullary canal before the introduction of PMMA in total hip or knee replacement – must be prominently displayed in all labeling,

{3}------------------------------------------------

# Page 2 -- Mr. Ian P. Gordon

including pouch box, and carton labels, instructions for use, and other promotional materials, in metuding pouch box, and careme, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act Please note that the above labeling innitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device. The FDA finding of substantial equivalence or your device in the market. This results in a classification for your device and period in your Section 510(k) premarket in notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
effecting vour device officating vour device and e If your device is classified (sec above) and vince sited in affecting your device can be
may be subject to additional controls. Existed on 800 - 800 - 800 - RDA may may be subject to addinonal confrois: Existing major regarded on 898. In addition, FDA may lound in the Code of I ederal Regarments your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised inal FDA s Issualice of a substitive only other requirements of the Act
that FDA has made a determination that your device and comples . You must compl that FDA has made a delefinination underican by other Federal agencies. You must comply
or any Federal statutes and regulations administered by other Poderal issing (21 CFR or any Federal statues and regulations administer of to: registration and listing (2 CFR Part
with all the Act's requirements, including, but not limited to: set forth in th with all the Act s requirements, mediating outscturing practice requirements as set forth in the 807); labelling (21 CFR Part 801); good manal.820); and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if an 1990-1050 quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your If you desire specific information about the upplication of Compliance at [phone]. Also,
device (21 CFR Part 801), please contact the Office of Compliance at (240) 27 device (21 CFR Part 801), picase condecting by reference to premarket notification' (21 CFR
please note the regulation entitled, "Misbranding by reference to premarkilities u please note the regulation chilities, "Misoranants" of the mation on your responsibilities under the Act to the toll f Part 807.97). You may outain outler general international, and Consumer Assistance at its toll-free Ironi the Drvision of Billian [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Murton MD for

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

#### Indications for Use

510(k) # (if known): _ _ < 0 5 13 7 1 ________________________________________________________________________________________________________________________________________

Device Name: Interbody Innovations Cement Restrictor

Indications for Use:

This device is intended for use in conjunction with Standard PMMA cement. The Interbody
out of the may and the may and to the made to the madellar canal before the This device is intended for use in codigned to occlude the medullar canal before the introvations Ochons Ocholine in total hip or knee replacement.

This device is not intended for use in spine applications. The safety and effectiveness have I ms device is to is to is implanted into the spine.

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

Over-the-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General. Restorative,
Neurological Devices
Number K051371