OSFERION

K061499 · Olympus America, Inc. · MQV · Jan 26, 2007 · Orthopedic

Device Facts

• Record ID: K061499
• Device Name: OSFERION
• Applicant: Olympus America, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

OSferion is a synthetic, porous bone void filler composed of β-tricalcium phosphate. Supplied as blocks, cylinders, granules, or wedges with 60% or 75% porosity. Intended for surgical or trauma-related bony voids in extremities, spine, or pelvis. Placed by surgeons to fill gaps; scaffold resorbs over time and is replaced by autogenous bone during healing. Does not provide mechanical structural support. Benefits include osteoconductive bone replacement.

Clinical Evidence

No clinical data provided. Safety and efficacy supported by clinical literature and bench testing comparisons to predicate devices.

Technological Characteristics

Material: β-tricalcium phosphate. Porosity: 60% and 75%. Form factor: blocks, cylinders, granules, wedges. Sterilization: High-pressure steam. Single-use. Non-structural (does not impart mechanical strength).

Indications for Use

Indicated for individuals with bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by surgery or trauma, where the void is not intrinsic to the stability of the bony structure.

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

• chronOS (K013072)
• Vitoss (K994337)

Submission Summary (Full Text)

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KO61499

JAN 26 2007

## 510(k) SUMMARY

### OSferion

Regulatory Affairs & Quality Assurance

Email:[e-mail] Establishment Registration No: 2429304

34-3 Hirai, Hinode-machi, Nishitama-gun,

Establishment Registration No: Form 2891 to be submitted to FDA upon 510(k) clearance.

Olympus Biomaterial Corporation Hinode Factory

Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA

Phone: [phone] FAX: [phone]

Tokyo 190-0182. Japan

## January 25, 2007

### 1 General Information

- E Applicant: Olympus Biomaterial Corporation 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182, Japan Establishment Registration No: Form 2891 to : be submitted to FDA upon 510(k) clearance. 배 Official Correspondent: Official Correspondent: Laura Storms-Tyler Executive Director
■ Manufacturer: (Sterilization site)

### 2 Device Identification

- Device Trade Name:
- Common Name:
- Regulation Number:

Regulatory Class:

Classification Panel:

- Regulation Name: Resorbable calcium salt bone void filler device
OSferion

Bone void filler

21 CFR 888.3045

- ll
-
- Product Code: MQV
- Orthopedic
-

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#### 3 Predicate Device Information

| Device Name: | chronOS | Vitoss |
|---------------|------------------|------------------|
| Common Name: | Bone void filler | Bone void filler |
| Manufacturer: | Synthes | Orthovita |
| 510(k) No. | K013072 | K994337 |

### 4 Device Description

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

The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.

#### 5 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.

#### Comparison of Technological Characteristics e

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

Comparison between the subject and predicate devices is shown in Table1. The clinical literature provided in this submission supports the safety and efficacy of OSferion.

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# Table 1. Comparison of Specifications Subject Device: OSferion Predicate Device: chronOS

| Specifications | Sublect Devic | | edicate Device |
|----------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indication/Intended<br>use | Bone void filler, synthetic | Bone void filler, synthetic | Bone void filler, synthetic |
| Patient population | Individuals with bone voids<br>or gaps, caused by surgery<br>or trauma. | Individuals with bone<br>voids or gaps, caused by<br>surgery or trauma. | Individuals with bone voids<br>or gaps, caused by surgery<br>or trauma. |
| Anatomical location | Bony voids or gaps of the<br>skeletal system, i.e., the<br>extremities, spine and<br>pelvis | Bony voids or gaps of the<br>skeletal system, i.e., the<br>extremities, spine and<br>pelvis | Bony voids or gaps of the<br>skeletal system, i.e., the<br>extremities, spine and pelvis |
| Labeling | Same intended use,<br>contradictions, warnings,<br>precautions and adverse<br>events as predicate | See enclosure | See enclosure |
| Structure of the<br>material | Interconnective porosity | Trabecular strucuture<br>similar to cancellous bone | Interconnective porosity |
| Chemical<br>composition of<br>material | B - Tricalciumphosphate<br>(CaCO3) | ß - Tricalciumphosphate<br>(CaCO3) | ß - Tricalciumphosphate<br>(CaCO 3) |
| Porosity of material | 60%,75% | 90% | 55% |
| Sterility | Sterile (High pressure<br>Steam)<br>Single use only | Sterile (gamma radiation)<br>Single use only | Sterile (gamma radiation)<br>Single use only |
| Biocompatibility | Established | Established | Established |
| Mechanical strength | Does not impart<br>mechanical strength to<br>surgical site | Does not impart<br>mechanical strength to<br>surgical site | Does not impart mechanical<br>strength to surgical site |

# 7 Conclusion

When compared to the predicate device, this particular device "OSferion" does not incorporate v men obtipant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus America, Inc. % Ms. Laura Storms-Tyler 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610

JAN 2 6 2007

Re: K061499

Trade/Device Name: OSferion Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device. Regulatory Class: Class II Product Code: MQV Dated: December 13, 2006 Received: December 26, 2006

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. Iisting 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. 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 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 yours. Mark N. Melk

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): 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)

icurrence of CDRH, Office of Device Evaluation (ODE) 10-101 Division of General, Restorative, and Neurological Devices

Experie : Minys Page

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