GRAFTYS BCP

K073064 · Graftys · MQV · Mar 11, 2008 · Orthopedic

Device Facts

• Record ID: K073064
• Device Name: GRAFTYS BCP
• Applicant: Graftys
• Product Code: MQV · Orthopedic
• Decision Date: Mar 11, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended. GRAFTYS®BCP can be used with autograft as a bone graft extender. In addition when used with appropriate opening osteotomy system devices, plates and screws, GRFATYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies

Device Story

GRAFTYS®BCP is a sterile, single-use, bioresorbable bone void filler. Composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate ceramic; features microporous and macroporous structure. Available as granules, sticks, cylinders, or wedges. Implanted by surgeons into skeletal voids or gaps caused by trauma or surgery; acts as an osteoconductive scaffold for bone ingrowth. Resorbs over time and is replaced by natural bone. Used in clinical settings, often alongside rigid fixation devices (plates/screws) or autograft. Provides a scaffold to support bone healing in non-load-bearing defects.

Clinical Evidence

Bench testing only. In vitro tests performed in accordance with the FDA Class II Special Controls Guidance Document for Resorbable calcium salt bone void filler devices.

Technological Characteristics

Microporous/macroporous ceramic scaffold; 60% Hydroxyapatite / 40% beta-Tricalcium Phosphate; 70% total porosity; interconnected mesoporosity. Provided sterile for single-use. Form factors: granules, sticks, cylinders, wedges.

Indications for Use

Indicated for patients requiring bone void filling in extremities, spine, or pelvis due to trauma or surgery. Used as bone graft extender or in femoral/tibial osteotomies with rigid fixation. Not for use in defects intrinsic to bony structure 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

• MBCP ™ - Resorbable calcium salt bone void filler device (K051774)
• VITOSS- Resorbable calcium salt bone void filler (K994337)

Submission Summary (Full Text)

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K07306 4

## MAR 1 1 2008

# Graftys

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

Prepared: October 15th, 2007

#### 1. Submitter Information

| Name : | GRAFTYS |
|------------|----------------------------------------------------------------------------------------------------|
| Address : | Eiffel Park – Bât D<br>415, rue Claude Nicolas Ledoux-<br>13 854 AIX EN PROVENCE Cedex 3<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®BCP |
|----------------|-------------------------------------------------------------------------|
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification | Resorbable calcium salt bone void filler device (CFR 888.3045 ; Product |
| name: | Code : MQV) |

#### 3. Legally Marketed Predicate Device

| Predicate | MBCP ™ - Resorbable calcium salt bone void filler device [K051774] |
|-----------|--------------------------------------------------------------------|
| | VITOSS- Resorbable calcium salt bone void filler [K994337] |

#### 4. Device Description

GRAFTYS®BCP is a sterile single use bioresorbable bone void filling substitute.

GRAFTYS®BCP is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate.

Following placement in the bony voids or gap, GRAFTYS®BCP resorbs and is replaced with bone during the healing process.

GRAFTYS®BCP is available in the form of granules, sticks, cylinders and wedges.

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#### 5. Intended Use

GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

GRAFTYS®BCP can be used with autograft as a bone graft extender.

In addition when used with appropriate opening osteotomy system devices, plates and screws, GRFATYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies

#### 6. Technological characteristics

GRAFTYS®BCP and the predicate device MBCP have the same technological characteristics and are osteoconductive scaffold for bone ingrowth. Both are sterile single use devices made of 60% Hydroxyapatite/40% β-Tricalcium Phosphate and have a similar porous structure (total volume ratio of 70%). As the predicate VITOSS, the interconnection between the pores is ensured by mesoporosity. GRAFTYS®BCP and predicates are provided sterile for single-use.

#### 7. Non clinical performance data

In vitro tests, 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®BCP and the predicate device.

#### 8. Conclusion

GRAFTYS®BCP is claimed to be substantially equivalent in term of safety and effectiveness to the predicate devices as a non structural osteoconductive bone void filler for osseous defect.

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Image /page/2/Picture/12 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Graftys % Mr. Anthony Le Naour 415 Rue Charles Nicolas Ledoux Eiffel Park Bat D Aix En Provence France 13854

MAR 1 1 2008

K073064 Re:

Trade/Device Name: GRAFTYS®BCP -- Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 28, 2008 Received: February 1, 2008

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.

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 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 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 Mulhusan

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

510(k) Number (if known): K073064

Device Name:

GRAFTYS®BCP - Resorbable Bone Void Filler

Indications For use:

GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

GRAFTYS®BCP can be used with autograft as a bone graft extender.

In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies

Prescription Use X (Part 21 CFR 801 Subpart D)

l

Over-The-Counter Use AND/OR (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)

Niel Rl Jule formxm

Division of General, Restorat and Neurological Devices

510(k) Number K073064

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