GRAFTYS HBS

K082498 · Graftys · MQV · Feb 25, 2009 · Orthopedic

Device Facts

• Record ID: K082498
• Device Name: GRAFTYS HBS
• Applicant: Graftys
• Product Code: MQV · Orthopedic
• Decision Date: Feb 25, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and the pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

Injectable, self-hardening, macroporous synthetic calcium phosphate bone substitute; supplied in double-compartment mixing syringe containing powder (calcium phosphate salts, HPMC) and phosphate-based aqueous solution. Manual or delivery-gun injection into bony voids; athermally forms calcium-deficient apatite in situ; hardens in ~15 minutes. Resorbed and replaced by bone during healing. Used in clinical settings by healthcare providers. Benefits patient by filling non-structural bone voids to facilitate natural bone regeneration.

Clinical Evidence

Bench testing only; in vitro and in vivo testing performed in accordance with the FDA Guidance for Industry: Resorbable calcium salt bone void filler device (June 2, 2003).

Technological Characteristics

Synthetic calcium phosphate bone substitute; components: calcium phosphate salts, HPMC, and Na2HPO4 solution. Injectable, self-hardening, macroporous. Athermal setting reaction. Sterile, non-pyrogenic, single-use.

Indications for Use

Indicated for patients with bony voids or defects in the skeletal system (extremities and pelvis) not intrinsic to bony stability. Applicable to surgically created osseous defects or those resulting from 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

• NORIAN® SRS® (K011897)

Submission Summary (Full Text)

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Koryys

Grafalys

FEB 2 5 2009

# GRAFTYS®HBS Resorbable Bone Void Filler 510(k) Summary

Prepared: August 22nd, 2008

## 1. Submitter Information

| Name : | GRAFTYS |
|------------|---------------------------------------------------------------------------------------------------|
| Address : | Eiffel Park – Bât D<br>415, rue Claude Nicolas Ledoux-<br>13 854 AIX EN PROVENCE Cedex3<br>FRANCE |
| Telephone: | + 33 (0) 4 42 60 30 00 |
| Facsimile: | + 33 (0) 4 42 60 30 11 |
| Contact: | Anthony LE NAOUR - Regulatory Manager |

#### Name of Device 2.

| Trade Name: | GRAFTYS®HBS |
|----------------------|----------------------------------------------------------------------------------------|
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification name: | Resorbable calcium salt bone void filler device (CFR 888.3045<br>; Product Code : MQV) |

### 3. Legally Marketed Predicate Device

Predicate NORIAN® SRS® - Resorbable calcium salt bone void filler device [K011897]

### 4. Device Description

GRAFTYS®HBS is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, 8cc of an injectable calcium-deficient apatite is athermally formed. In-vivo, this apatite which hardens in approximately 15 min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®HBS is a sterile, non-pyrogenic, single-use product.

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### 5. Intended Use

GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

#### 6. Technological characteristics

GRAFTYS®HBS and the predicate device NORIAN® SRS® have the same intended use, the same principle of operation and very similar technological characteristics. The minor technological differences do not raise any new issues of safety or effectiveness.

### 7. Non clinical performance data

In vitro and in-vivo testing, performed according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device: Guidance for Industry and FDA June 2, 2003, support the substantial equivalence between GRAFTYS®HBS and the predicate device.

### 8. Conclusion

GRAFTYS®HBS is claimed to be substantially equivalent in term of safety and effectiveness to the predicate devices as a resorbable calcium salt bone void filler device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.

Graftys % Mr. Anthony Le Naour Regulatory Manager 415, rue Claude Nicolas Ledoux F-13854 Aix en Provence Cedx3

FEB 2 5 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### Re: K082498

France

Trade/Device Name: GRAFTYS® HBS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable bone substitute Regulatory Class: II Product Code: MQV Dated: January 30, 2009 Received: February 5, 2009

Dear Mr. Le Naour:

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 - Mr. Anthony Le Naour

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. Melkerson
Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

510(k) Premarket Notification Graftys GRAFTYS®HBS- Resorbable Bone Void Filler

# Statement of Indications for Use

510(k) Number (if known):

Device Name:

GRAFTYS®HBS

Indications For use:

GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and the pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides 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 (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE IF NEEDED)

A BE HERE BE BREAK (ODE) Concurrence of CDRH, OA Division of General, Restorative, and Neurological Devices

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510(k) Number L024151