OSFERION

K080065 · Olympus Terumo Biomaterials Corporation · MQV · May 2, 2008 · Orthopedic

Device Facts

• Record ID: K080065
• Device Name: OSFERION
• Applicant: Olympus Terumo Biomaterials Corporation
• Product Code: MQV · Orthopedic
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Story

OSferion is a porous, synthetic bone void filler composed of beta-tricalcium phosphate (ß-TCP). Supplied in various forms—blocks, cylinders, granules, and wedges—with porosities of 60% or 75%. Intended for surgical or trauma-related bony voids not critical to structural stability. Implanted by surgeons; acts as a scaffold for osteoconduction; resorbs over time and is replaced by autogenous bone during the natural healing process. Benefits include providing a temporary structural matrix to facilitate bone regeneration.

Clinical Evidence

No clinical trials were conducted for this specific submission; safety and efficacy were supported by provided clinical literature.

Technological Characteristics

Material: ß-tricalcium phosphate (ß-TCP). Porosity: 60% or 75%. Form factors: blocks, cylinders, granules, wedges. Resorbable calcium salt bone void filler. Non-software device.

Indications for Use

Indicated for patients requiring bone void filling in the skeletal system (extremities, spine, pelvis) for voids/gaps not intrinsic to bony 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

• Synthes (USA) chronOS ™ (K043045)
• Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409)
• OSferion (K061499)

Submission Summary (Full Text)

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K080065

ੇ ਹੋ ਹੈ

## 510(k) SUMMARY

## OSferion

# MAY - 2 2008

## November 30th, 2007

#### 1 General Information

| | Applicant: | OLYMPUS TERUMO BIOMATERIALS CORP.<br>34-3 Hirai, Hinode-machi, Nishitama-gun,<br>Tokyo 190-0182, Japan<br>Establishment Registration No:<br>Active; awaiting assignment of registration number |
|---|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Official Correspondent: | Laura Storms-Tyler<br>Regulatory Affairs & Quality Assurance<br>Olympus America Inc.<br>3500 Corporate Parkway<br>PO Box 610<br>Center Valley PA18034-0610,<br>Phone: [phone]<br>Facsimile: [phone]<br>Email:[e-mail]<br>Establishment Registration No: 2429304 |
| | | |
| ■ | Manufacturer:<br>(Sterilization site) | OLYMPUS TERUMO BIOMATERIALS CORP.<br>Hinode Factory<br>34-3 Hirai, Hinode-machi, Nishitama-gun,<br>Tokyo 190-0182, Japan<br>Establishment Registration No: |

#### 2 Device Identification

| ■ | Device Trade Name: | OSferion |
|---|-----------------------|-------------------------------------------------|
| ■ | Common Name: | Bone void filler |
| ■ | Regulation Number: | 21 CFR 888.3045 |
| ■ | Regulation Name: | Resorbable calcium salt bone void filler device |
| ■ | Regulatory Class: | II |
| ■ | Classification Panel: | Orthopedic |
| ■ | Product Code: | MQV |

Active; awaiting assignment of registration number

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K060065

#### 87 Predicate Device Information

| | Predicate Device | | |
|---------------|-------------------------|--------------------------------------------------------------|-----------------------------------------|
| Device Name: | Synthes (USA) chronOS ™ | Vitoss® Scaffold<br>Synthetic Cancellous<br>Bone Void Filler | OSferion |
| Common Name: | Bone void filler | Bone void filler | Bone void filler |
| Manufacturer: | Synthes | Orthovita | OLYMPUS TERUMO<br>BIOMATERIALS<br>CORP. |
| 510(k) No. | K043045 | K032409 | K061499 |

#### 4 Device Description

OSferion is a white porous material composed of ß-tricalcium phosphate(ß-TCP). It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSfenon is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation.

The OSferion product range consists of two product types with porosities of 75% and 60%. Products are supplied in blocks, cylinders, granules and wedges.

#### ട് Indications for Use

OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

#### 6 Comparison of Technological Characteristics

OSferion is basically identical to the predicate devices in indication for use, and is similar in specifications of the material.

The clinical literatures provided in this submission supports the safety and efficacy of OSferion.

#### 7 Conclusion

When compared to the predicate device, this subject device "OSferion" does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Terumo Biomaterials Corporation % Olympus America Inc. Ms. Laura Storms-Tyler 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034

Re: K080065

Trade/Device Name: OSferion Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone filler device Regulatory Class: II Product Code: MQV Dated: April 24, 2008 Received: April 25, 2008

Dear Ms. Storms-Tyler:

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.

MAY - 2 2008

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. Laura Storms-Tyler

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 N. Millican

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 Statement

510(k) Number (if known): K040065

Device Name: OSferion

Indications for Use:

OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure.

Following placement in the bony void or gap, the calcium phosphate scaffold 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)

Neil RP Ogden for man

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

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K080065 510(k) Number_