GRAFTY QUICKSET

K093343 · Graftys · MQV · Apr 22, 2010 · Orthopedic

Device Facts

• Record ID: K093343
• Device Name: GRAFTY QUICKSET
• Applicant: Graftys
• Product Code: MQV · Orthopedic
• Decision Date: Apr 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GRAFTYS®QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., 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.

Device Story

Injectable, self-hardening, macroporous synthetic calcium phosphate bone substitute; supplied in double-compartment mixing syringe containing 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 approximately 2 minutes. Resorbs and is replaced by bone during healing. Used by clinicians in surgical settings for non-structural skeletal defects.

Clinical Evidence

Bench testing only; no clinical data provided. In vitro testing performed in accordance with FDA Class II Special Controls Guidance Document for resorbable calcium salt bone void filler devices.

Technological Characteristics

Synthetic calcium phosphate bone substitute; components: calcium phosphate salts, HPMC, and Na2HPO4 aqueous solution. Macroporous, injectable, self-hardening. Sterile, single-use. Athermal formation of calcium-deficient apatite.

Indications for Use

Indicated for patients with non-structural bony voids or defects in the skeletal system, specifically the extremities and pelvis, resulting from surgery 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

• GRAFTYS®HBS (K082498)

Submission Summary (Full Text)

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K093343

G

# Graftys

GRAFTYS® Quickset Resorbable Bone Void Filler 510(k) Summary

APR 2 2 2010

Prepared: October, 14, 2009

## 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 |

## 2. Name of Device

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

### 3. Legally Marketed Predicate Device

Predicates GRAFTYS®HBS - Resorbable calcium salt bone void filler device [K082498]

### 4. Device Description

GRAFTYS®QUICKSET 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, an injectable calcium-deficient apatite is athermally formed. Invivo, this apatite which hardens in approximately 2min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®QUICKSET is a sterile single-use product.

GRAFTYS - S.A. au capital de 537.037 Euros - Siret 484 024 989 - APE 2120Z Eiffel Park - Bât D - 415, rue Claude Nicolas Ledoux - F-13 854 Aix en Provence Cedex 3, France Tel : [phone] - Fax : + 33 (0)4 42 60 30 11 - [e-mail] www.graftys.com

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# Graftys

## 5. Intended Use

GRAFTYS®QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., 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®QUICKSET and the predicate GRAFTYS®HBS devices 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 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®QUICKSET and the predicate device GRAFTYS®HBS.

### 8. Conclusion

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GRAFTYS APR 2 2 2010 % Mr. Anthony Le Naour Regulatory Affairs Manager Eiffel Park – Bât D 415, rue Claude Nicolas Ledoux 13854 AIX EN PROVENCE Cedex3 France

Re: K093343

Trade/Device Name: GRAFTYS® Quickset Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 30, 2010 Received: March 30, 2010

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Anthony Le Naour

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Barbara Boettner

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Statement of Indications for Use

510(k) Number (if known): K093343

Device Name:

GRAFTYS® Quickset

Indications For use:

GRAFTYS® Quickset is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® Quickset is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., 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.

Prescription Use X (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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093343

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