MERRIES UNI-OSTEO, MODEL CS30250-CS10102

K051698 · Merries International, Inc. · MQV · Sep 29, 2005 · Orthopedic

Device Facts

• Record ID: K051698
• Device Name: MERRIES UNI-OSTEO, MODEL CS30250-CS10102
• Applicant: Merries International, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.

Device Story

Merries UNI-OSTEO Pellets are a resorbable bone void filler composed of calcium sulfate (CaSO4). The device acts as an osteoconductive scaffold to facilitate new bone growth in non-structural bony defects. It is intended for surgical use by clinicians to fill voids resulting from trauma or surgical procedures. The pellets are radiopaque, allowing for identification and monitoring of implant location via radiographs. The material dissolves in the body over 30-60 days, with the resorption rate corresponding to new bone formation. The device provides a mechanical filler to support bone healing without providing structural stability to the skeletal system.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, intracutaneous reactivity, maximization sensitization, genotoxicity, and implantation) confirmed the device is non-cytotoxic, non-sensitizing, and non-mutagenic. Mechanical testing demonstrated strength equivalent to predicate devices. Sterility was validated via dose auditing.

Technological Characteristics

Material: Calcium sulfate (CaSO4) conforming to USP/NF monograph. Form factor: Pellets. Principle: Osteoconductive scaffold. Resorption: 30-60 days. Radiopaque. Sterilization: Validated dose auditing.

Indications for Use

Indicated for filling bony defects (surgically created or traumatic) in the skeletal system that are not intrinsic to structural stability.

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

• Osteoset™ Pellets (K963587, K963562)
• Jax™ (K010555)

Submission Summary (Full Text)

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K051698 p1/2

## SEF 2 9 2005

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Merries International Inc. 2F 3-1, Bau-Hung Rd., Shin-Tien Taipei, Taiwan,

# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of 21CFR 807.92

### Merries UNI-OSTEO Pellets Bone Graft Substitute

#### 1. Submitted by:

Merries International Inc. 2F 3-1, Bau-Hung Rd., Shin-Tien Taipei, Taiwan, R.O.C. Tel: [phone] Fax: [phone] Contact person: Jessica Li

- 2. Date prepared: May 23, 2005
- 3. Trade name: Merries UNI-OSTEO Pellets Bone Graft Substitute
- 4. Product classification: Unclassified
- ર. Device product code and panel code: 87MQV/Orthopedic
- 6. Common name: Resorbable calcium salt bone void filler device (21 CFR 888.3045)

#### 7. Indications for use:

Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.

#### 8. Device description:

Merries UNI-OSTEO pellets are made of calcium sulfate (CaSO4). These pellets dissolve safely and completely in the body in approximately 30-60 days and resorption rate corresponds with new bone growth. The product is visible on radiographs so that the implant location can be easily identified and monitored.

Merries UNI-OSTEO pellets are osteoconductive meaning that these pellets act as a scaffold and facilitate new bone growth.

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i 051698 1/2

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Merrics International Inc. 2F 3-1, Bau-Hung Rd., Shin-Tien Taipei, Taiwan,

#### 9. Statement of substantial equivalence:

Merries UNI-OSTEO Pellets Bone Graft Substitute is substantially equivalent in base materials, function and intended use to the following devices:

- Osteoset™ Pellets (K963587, K963562) . Manufactured by Wright Medical Technology, Inc.
- Jax™ (K010555) . Manufactured by Smith & Nephew, Inc.
- 10. Material: The raw material, calcium sulfate, conforms to the requirements of United States Pharmacopoeia(USP) National Formulary(NF) "Official Monograph for Calcium Sulfate"

### 11. Testing summary:

- After taking into account the intended use and the device contact . duration(>30days), the following biocompatibility tests have been completed and results support that Merries UNI-OSTEO is non-cytotoxic, non-sensitizing, non-mutagenic, and compatible with surrounding tissues.

| Biocompatibility Tests | Results |
|---------------------------------|---------|
| Cytotoxicity | Pass |
| Intracutaneous Reactivity Test | Pass |
| Maximization Sensitization Test | Pass |
| Genotoxicity | Pass |
| Implantation | Pass |

- Merries UNI-OSTEO has been tested of sterilization dose auditing for sterility. .
- The mechanical testing showed equivalent strength to the predicate device. .

Summaries and reports of all data are contained in the Premarket Notification Submission.

### 12. Summary of technological characteristics:

The device is substantial equivalence to the predicate devices based on the same material characteristics and intended use. In additional, biocompatibility tests and well documented material support its safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2005

Ms. Jessica Li Merries International Inc. 2F 3-1, Bau-Hung Road Shin-Tien, Taipei, Taiwan, R.O.C.

Re: K051698

Trade/Device Name: Merries UNI-OSTEO Pellets Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: September 8, 2005 Received: September 8, 2005

Dear Ms. Li:

We have reviewed your Scction 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 IDA'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. Karen L. Baker

This letter will allow you to begin marketing your device as described in your Scction 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/dsma/dsmamain.html

Sincerely yours,

Mark N-Melkison

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.3 Statement of indication for use

510(k) Number:

Device Name: Merries UNI-OSTEO Pellets Bone Graft Substitute

ndications For Use:

Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.

Mark H. Milliman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

K051698'

X Prescription Use (Part21 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)