WELLGRAFT PE I

K072444 · Gwowei Technology Co., Ltd. · MQV · Apr 4, 2008 · Orthopedic

Device Facts

• Record ID: K072444
• Device Name: WELLGRAFT PE I
• Applicant: Gwowei Technology Co., Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Apr 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

WELLGRAFT PE I Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine 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. Wellgraft PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.

Device Story

Wellgraft PE I is a resorbable bone void filler composed of high-purity calcium sulfate hemihydrate powder and a mixing solution. Upon mixing, it forms a radiopaque paste or putty applied digitally or via injection into bone defects. It acts as an osteoconductive scaffold to facilitate new bone growth; it resorbs in approximately 60-90 days, replaced by native bone. Used by surgeons in clinical settings for orthopedic procedures. Supplied sterile for single-patient use.

Clinical Evidence

Bench testing only. Device conforms to ISO 10993 (biological evaluation) and ASTM F2224-03 (standard specification for high purity calcium sulfate hemihydrate).

Technological Characteristics

Material: High purity calcium sulfate hemihydrate. Form: Powder and mixing solution forming a radiopaque paste/putty. Standards: ASTM F2224-03, ISO 10993, ANSI/AAMI/ISO 11137. Sterilization: Radiation.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to bone stability. Applicable to surgically created osseous defects or traumatic bone injuries. In the spine, limited to posterolateral fusion procedures. 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

• OSTEO-G BONE VOID FILLER SYSTEM (K031319)

Submission Summary (Full Text)

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K072444

## 510(K) SUMMARY

APR - 4 2008

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

| 1. Submitter's Name: | GWOWEI Technology CO., LTD. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 5F, No. 99, Sec. 1, Jhongcheng Rd., Shilin District , Taipei City , |
| | TAIWAN |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Mr. Wilson Yeh / Manager |
| 2. Device Name : | |
| Trade Name: | WELLGRAFT PE I Resorbable Bone Void Filler |
| Common Name: | Bone Void Filler |
| Classification name | filler, bone void, calcium compound |
| 3. DEVICE CLASS | WELLGRAFT PE I Resorbable Bone Void Filler have been |
| | classified as |
| | Regulatory Class: II |
| | Product Code: MQV |
| | Panel : Orthopedic |
| | Regulation Number: 21CFR 888.3045 |
| 4. Predicate Device: | The predicate device is the |
| | • OSTEO-G BONE VOID FILLER SYSTEM (K031319) |
| | marketed by ASPINE USA, INC. |
| 5. Device Description: | The WELLGRAFT PE I Resorbable Bone Void Filler<br>consists of high purity grade calcium sulfate hemihydrate<br>powder and mixing solution. When mixed according to the<br>directions, WELLGRAFT PE I Resorbable Bone Void Filler forms<br>the biodegradable, biocompatible and rediopaque paste or<br>putty, and can then be digitally applied directly or by injection<br>into the defect site. |
| | WELLGRAFT PE I Resorbable Bone Void Filler is<br>osteoconductive which acts as a scaffold and facilitate new<br>bone growth. After implanted, it will be resorbed in<br>approximately 60~90 days and be replaced by new bone<br>during the healing process. This product is supplied sterile<br>for single patient use. |
| Product:<br>Page 1 of 2 | WELLGRAFT PE I Resorbable Bone Void Filler<br>Section 4 - 510(k) Summary<br>REV. (C) |

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- WELLGRAFT PE I Resorbable Bone Void Filler is indicated 6. Intended Use: to fill bony void or gaps of the skeletal system (i.e., the extremities, spine 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. WELLGRAFT PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
- 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 ----etc.

## 8. Conclusions:

The WELLGRAFT PE I Resorbable Bone Void Filler has the same intended use and similar technological characteristics as the OSTEO-G BONE VOID FILLER SYSTEM (K031319) marketed by ASPINE USA, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the WELLGRAFT PE I Resorbable Bone Void Filler is substantially equivalent to 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 and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GWOWEI Technology Co., Ltd. % Harvest Consulting Corporation Ms. Jennifer Reich 2904 N. Boldt Drive Flagstaff, AZ 86001

APR - 4 2008

Re: K072444

Trade/Device Name: Wellgraft PE I Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 2, 2008 Received: April 3, 2008

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.

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 - Ms. Jennifer Reich

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson 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): K#072444

## Device Name: WELLGRAFT PE I Resorbable Bone Void Filler GWOWEI Technology CO., LTD.

Indications for Use:

WELLGRAFT PE I Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine 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. Wellgraft PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.

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)

Neith R.P. Gohm for mx

Division S Division of General, Restorative, and Neurological Devices

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**510(k) Number** K072444