GENEX

K082381 · Biocomposites, Ltd. · MQV · Nov 14, 2008 · Orthopedic

Device Facts

• Record ID: K082381
• Device Name: GENEX
• Applicant: Biocomposites, Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Nov 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis). Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Story

Genex® is a resorbable calcium salt bone graft substitute; provided sterile for single-patient use. Clinician packs paste into skeletal voids or defects (long bones, extremities, spine, pelvis); material can be injected, digitally packed to cure in situ, or molded into solid implants. Device acts as a scaffold; resorbs over time; replaced by new bone during healing process. Used in surgical settings to fill non-structural bony defects.

Clinical Evidence

No clinical data provided; substantial equivalence based on non-clinical testing and comparison to predicate device.

Technological Characteristics

Resorbable calcium salt bone graft substitute. Provided sterile for single use. Formulated as a paste for injection or molding into solid implants.

Indications for Use

Indicated for patients with bony voids or defects in the skeletal system (long bones, extremities, spine, pelvis) that are not intrinsic to structural stability. Defects may be surgically created or result 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.

Submission Summary (Full Text)

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# NOV 1 4 2008

## 510(k) SUMMARY

Genex®

- Biocomposites Ltd Applicant Keele Science Park Keele Staffordshire England ST5 SNL
Mr Simon Fitzer Contact Person [phone] Tel: [phone] Fax Email: [e-mail]

Classification Name: Common/Usual Name: Trade/Proprietary Name Product Code

Filler, bone void, calcium compound Bone void filler Genex® MQV

### Device Description

Genex® is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process.

Genex® is completely resorbed and replaced with bone during the healing process.

Genex® is provided sterile for single use only

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#### Intended Use / Indications

Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.

Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis).

Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect

The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

#### Summary of Technology

Genex® has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness.

#### Non Clinical Testing

Data supplied demonstrates that Genex® is substantially equivalent to the predicate device and any differences do not any concerns regarding safety and effectiveness.

#### Substantial Equivalence

The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent.

Documentation provided demonstrates that the Genex® is substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the subject device.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2008

Biocomposites Ltd % Mr. Simon Fitzer Keele Science Park Keele, Staffordshire England ST5 5NL

Re: K082381 Trade/Device Name: Genex® Regulation Number: 21 CFR 888.3045 Regulation Names: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 8, 2008 Reccived: August 19, 2008

Dear Mr. Fitzer:

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. Simon Fitzer

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. Wilkinson

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):

Genex® Device Name:

Indications For Use:

Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.

Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis).

Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect

The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

V Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter use (Part 21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.W. mo Rimm
Division Sign-Off

Division of General, Restorative, and Neurological Devices

**510(k) Number** k062381 Page 1 of 1