A-GRIX TE RESORABLE BONE VOID FILLER

K121453 · Ag Digital Technology Corp. · MQV · Feb 5, 2013 · Orthopedic

Device Facts

• Record ID: K121453
• Device Name: A-GRIX TE RESORABLE BONE VOID FILLER
• Applicant: Ag Digital Technology Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A-GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.

Device Story

A-GRIX TE is a resorbable bone void filler consisting of a pre-measured surgical grade calcium salt mixture and a mixing solution. Upon mixing, it forms a radiopaque paste or putty. The clinician applies the material directly into the bone defect site. Once applied, the material hardens in situ, acting as an osteoconductive scaffold to provide temporary intra-operative support and facilitate new bone growth. The filler is designed to resorb over time and be replaced by natural bone during the healing process. It is supplied sterile for single-patient use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Calcium salt mixture; radiopaque; osteoconductive scaffold; conforms to ASTM F2224-03 (High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants) and ISO 10993 series (biological evaluation). Sterilized via radiation (ANSI/AAMI/ISO 11137).

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis) not intrinsic to bone stability, including surgically created osseous defects from traumatic injury. May be used at infected sites.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• A-GRIX Resorbable Bone Void Filler (K091688)

Submission Summary (Full Text)

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

K121453\$_{1/2}\$

# 510(K) SUMMARY

### FEB 0 5 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

| Date of Prepare: Dec. 8, 2012 | |
|-------------------------------|------------------------------------------------------------------|
| 1. Submitter's Name: | AG DIGITAL Technology Corp. |
| Address: | 11F, No. 15, Chi-nan Rd., Sec.1, Taipei (10051), TAIWAN |
| Phone: | + 886-2-23575864 |
| Fax: | + 886-2-23575845 |
| Contact: | Frank Chou / Manager |
| 2. Device Name : | |
| Trade Name: | A-GRIX TE Resorbable Bone Void Filler |
| Common Name: | Bone Void Filler |
| Classification name | filler, bone void, calcium compound |
| 3. DEVICE CLASS | A-GRIX TE Resorbable Bone Void Filler has been |
| | classified as |
| | Regulatory Class: II |
| | Product Code: MQV |
| | Panel : Orthopedic |
| | Regulation Number: 21CFR 888.3045 |
| 4. Predicate Device: | The predicate device is the |
| | • A-GRIX Resorbable Bone Void Filler (K091688) |
| | marketed by AG DIGITAL Technology Corp. |
| 5. Device Description: | The A-GRIX TE Resorbable Bone Void Filler consists of 1 |
| | bottle of pre-measured surgical grade calcium salt mixture |
| | and 1 bottle of mixing solution. When mixed according to the |
| | direction, A-GRIX TE forms the biodegradable, biocompatible |
| | and radiopaque paste or putty for digitally applying directly or |
| | by dispensing into the defect site. |

Page 1 of 2

Product: A-GRIX TE Resorbable Bone Void Filler Section 4 - 510(k) Summary REV. 【B】

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

Then A-GRIX TE will harden in situ which acts as an osteoconductive scaffold and provides temporary intra-operative support to facilitate new bone growth. This product is supplied sterile for single patient use.

A-GRIX TE Resorbable Bone Void Filler is indicated to fill 6. Intended Use: bony void or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.

The device conforms to applicable standards includes ISO 7. Performance 10993 series : Biological evaluation of medical devices , ASTM Summary: F2224-03 : Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants & ANSVAAMI/ISO 11137 Sterilization of Health Care Products -Radiation Sterilization.

#### 8. Conclusions:

The A-GRIX TE Resorbable Bone Void Filler has the same intended use and technological characteristics as the A-GRIX Resorbable Bone Void Filler (K091688) marketed by AG DIGITAL Technology Corp.. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the A-GRIX TE Resorbable Bone Void Filler is substantially equivalent to the predicate device.

Product: Page 2 of 2

A-GRIX TE Resorbable Bone Void Filler Section 4 - 510(k) Summary REV. 【B】 2/2

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

Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.

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 a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

Letter dated: February 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

AG Digital Technology Corporation % Harvest Consulting Corporation (USA) Ms. Jennifer Reich Senior Consultant 2904 North Boldt Drive Flagstaff, Arizona 86001

Re: K121453

Trade/Device Name: A-GRIX TE Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 10, 2012 Received: December 14, 2012

Dear Ms. Reich:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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

#### Page 2 - Ms. Jennifer Reich

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

## Mark N. Melkerson

- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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

## Indications for Use

K121453 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: A-GRIX TE Resorbable Bone Void Fiiller

Indications for Use:

A- GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.

V 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)

Laurence D. Coyne

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121453

Page 1 of 1