MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004

K050699 · Amedica Corp. · JDK · Apr 15, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050699
• Device Name: MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
• Applicant: Amedica Corp.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following: - Total Hip Arthroplasty . - Total Knee Arthroplasty . - Total or Hemi Shoulder Arthroplasty . The device is not intended for use in spinal surgeries.

Device Story

Vented Cement Restrictor used in cemented orthopedic procedures (hip, knee, shoulder arthroplasty). Device features ball valve mechanism to alleviate distal intra-medullary air pressure during cement application. Used by orthopedic surgeons in clinical settings. Benefits include pressure reduction within the medullary canal during surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from polymer or ceramic materials. Features a ball valve for venting intra-medullary air pressure. Designed for use in cemented arthroplasty.

Indications for Use

Indicated for patients undergoing total hip, total knee, or total/hemi shoulder arthroplasty requiring a cement restrictor. Contraindicated for spinal surgeries.

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

• Amedica Vented Cement Restrictor (K022729)
• Quantum Orthopedics Cement Restrictor (K040276)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

| SPONSOR NAME: | Amedica Corp.<br>615 Arapeen Drive<br>Suite 302<br>Salt Lake City, Utah 84108 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth<br>Phone: [phone]<br>E-Mail: [e-mail] |
| TRADE NAME: | Vented Cement Restrictor |
| COMMON NAME: | Instrument, Surgical, Sonic and Accessory/Attachment |
| CLASSIFICATION: | Instrument, Surgical, Sonic and Accessory/Attachment (Product<br>Code 87 JDX) are Class II per 21 CFR §888.4580, reviewed by the<br>Orthopedic Devices panel. |

#### PREDICATE DEVICES:

- Amedica Vented Cement Restrictor (K022729) .
- Quantum Orthopedics Cement Restrictor (K040276) .

## DEVICE DESCRIPTION:

The Vented Cement Restrictor used in cemented applications for hip, knee, and shoulder THE Vented Outlier (Sollieter Less The Vented Cement Restrictor features a ball valve which arthropiasty, is a polymorio abothe e stem, thus alleviating distal intra-medullary air pressure Surely Vonto an trapped chanufactured from either the above material or from a ceramic material.

#### INTENDED USE:

The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:

- Total Hip Arthroplasty .
- Total Knee Arthroplasty .
- Total or Hemi Shoulder Arthroplasty .

The device is not intended for use in spinal surgeries.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance tests, design comparisons, and functional analyses conducted on the Vented r Chomiano total device that it is substantially equivalent to the predicate devices.

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APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert M. Wolfarth Director of Quality Assurance and Regulatory Affairs Amedica Corporation 615 Arapeen Drive, Suite 302 Salt Lake City, Utah 84108

Re: K050699

Trade/Device Name: Vented Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: March 17, 2005 Received: March 18, 2005

Dear Mr. Wolfarth:

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 assumer 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 r trass be actived a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or uny I 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 Of It Fatt 6077, laceming (QS) regulation (21 CFR Part 820); and if applicable, the electronic rord in the quant) 35000 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Robert M. Wolfarth

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and n yourse FDA finding of substantial equivalence of your device to a legally prematic licultuation " " = " = " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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 active of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Stipt Rurls

Miriam C. Provost, Ph.D. Acting 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): K650699

Device Name: _Vented Cement Restrictor

Indications for Use:

The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:

- Total Hip Arthroplasty .
- Total Knee Arthroplasty .
- Total or Hemi Shoulder Arthroplasty .

The device is not intended for use in spinal surgeries.

Prescription Use
(Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styph Purda

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(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number

(Posted November 13, 2003)