OSTEO-LINK BONE VOID FILLER PELLETS

K060809 · Promed Advance Technology Co., Ltd. · MQV · Jul 3, 2006 · Orthopedic

Device Facts

• Record ID: K060809
• Device Name: OSTEO-LINK BONE VOID FILLER PELLETS
• Applicant: Promed Advance Technology Co., Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osteo-Link Bone Void Filler Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. Theses defects may be surgically created the defects or osseous defects created from traumatic injury to the bone. The pelleds provide the bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

Osteo-Link Bone Void Filler Pellets consist of high-purity, pharmaceutical-grade calcium sulfate. Device is provided sterile for single-patient use. Clinician packs pellets into non-structural bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by surgery or trauma. Pellets act as a resorbable scaffold, filling the void and gradually resorbing over approximately 14 weeks as they are replaced by natural bone during the healing process. Device is intended for use by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Device conforms to ISO 10993 (biological evaluation) and ASTM F2224-03 (calcium sulfate for surgical implants).

Technological Characteristics

Material: High-purity pharmaceutical-grade calcium sulfate. Conforms to ASTM F2224-03. Sterilization: Radiation (ANSI/AAMI/ISO 11137). Form factor: Pellets. Resorbable.

Indications for Use

Indicated for patients with non-structural bony voids or gaps in the skeletal system, including extremities, spine, and pelvis, resulting from surgical procedures or traumatic injury.

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

• Wright Plaster of paris pellets (K963562)

Submission Summary (Full Text)

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K060809

# 510(K) SUMMARY

JUL - 3 2006

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: | PROMED Advance Technology Co., Ltd. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2F-5, No. 289, Sec. 1, Dunhua S. Rd., Taipei 10689,<br>TAIWAN |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Mr. Wilson Yeh / Vice President |
| 2. Device Name : | |
| Trade Name: | Osteo-Link Bone Void Filler Pellets |
| Common Name: | Calcium sulfate |
| Classification name | filler, bone void, calcium compound |
| 3. DEVICE CLASS | Osteo-Link Bone Void Filler Pellets have been classified as<br>Regulatory Class: II<br>Product Code: MQV<br>Panel : Orthopedic<br>Regulation Number: 21CFR 888.3045 |
| 4. Predicate Device: | The predicate device is the<br>• Wright Plaster of paris pellets(K963562) marketed by<br>WRIGHT MEDICAL TECHNOLOGY, INC. |
| 5. Device Description: | Osteo-Link Bone Void Filler Pellets are made of high purity pharmaceutical grade calcium sulfate. The biodegradable, radiopaque pellets are resorbed in approximately 14 weeks when used according to labeling. Osteo-Link Bone Void Filler Pellets are provide sterile for single patient use. |

Osteo-Link Bone Void Filler Pellets Product: Page 1 of 2 Section 4 – 510(k) Summary REV.uCu

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- Osteo-Link Bone Void Filler Pellets are indicated only for 6. Intended Use: bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. Theses defects may be surqically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide the bone void filler that resorbs and is replaced with bone during the healing process.
- The device conforms to applicable standards includes ISO 7. Performance 10993 series : Biological evaluation of medical devices , Summary: ASTM 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 Osteo-Link Bone Void Filler Pellets has the same intended use and similar technological characteristics as the Wright Plaster of paris pellets(K963562) marketed by WRIGHT MEDICAL TECHNOLOGY, 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 Osteo-Link Bone Void Filler Pellets 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 three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

PROMED Advance Technology Co., Ltd. % Harvest Consulting Corporation Ms. Jennifer Reich 2904 N. Boldt Drive Flagstaff, Arizona 86001

Re: K060809

Trade/Device Name: Osteo-Link Bone Void Filler Pellets Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulation Class: II Product Code: MQV Dated: June 16, 2006 Received: June 19, 2006

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 Office 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 vours.

Barbara Muchus

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

X 060 809 510(k) Number (if known):

### Device Name: Osteo-Link Bone Void Filler Pellets PROMED Advance Technology Co., Ltd.

Indications For Use:

Osteo-Link Bone Void Filler Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. Theses defects may be surgically created the defects or osseous defects created from traumatic injury to the bone. The pelleds provide the bone void filler that resorbs and is replaced with bone during the healing process.

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)

**(Division Sign-Off)**

Division of General, Restorative.

and Neurological Devices

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510(k) Number K041809