ALLOGRAN-R

K061311 · Biocomposites, Ltd. · MQV · Sep 22, 2006 · Orthopedic

Device Facts

• Record ID: K061311
• Device Name: ALLOGRAN-R
• Applicant: Biocomposites, Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.

Device Story

Allogran-R® is a bioabsorbable bone void filler composed of calcium salts. Supplied as granules or preformed shapes; intended for use by surgeons to fill bony voids or gaps resulting from trauma or surgery. Device is mixed with saline or blood prior to application. Acts as a scaffold to support bone healing in non-load-bearing sites. Used in clinical settings; provides a resorbable material that fills defects, facilitating natural bone repair.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing demonstrating performance characteristics comparable to predicate devices.

Technological Characteristics

Bioabsorbable bone void filler; material: calcium salts; form factor: granules or preformed shapes; intended for surgical implantation; non-load-bearing application.

Indications for Use

Indicated for patients requiring bone void filling in extremities, spine, or pelvis due to trauma or surgery, where the defect is not intrinsic to structural 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

• Vitoss Scaffold (K032409)
• βGran (K041616)

Submission Summary (Full Text)

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K061311

## SEP 2 2 2006

# 510(k) SUMMARY

# Allogran-R®

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

| Classification Name: | Filler, bone void, calcium compound |
|------------------------|-------------------------------------|
| Common/Usual Name: | Filler, bone void, calcium compound |
| Trade/Proprietary Name | Allogran-R® |
| Product Code | MVQ |

#### Legally Marketed Predicate Devices

| | Trade Name | Manufacturer | 510(k) No |
|---|-----------------|-----------------|-----------|
| 1 | Vitoss Scaffold | Orthovita | K032409 |
| 2 | βGran | Orthos (UK) Ltd | K041616 |

### Device Description

Allogran-R® is a bioabsorbable device manufactured from calcium salts and may be supplied in the form of granules or other preformed shapes.

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#### Intended Use / Indications

Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.

#### Summary of Technology

Allogran-R® has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness.

#### Non Clinical Testing

Test data supplied demonstrates that the Allogran-R® is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness.

### Substantial Equivalence

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2006

Biocomposites Ltd. % Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keele Staffordshire United Kingdom ST5 5NL

· Re:-K061311

Trade Name: Allogran-R® Regulation Number: 21 CFR 888.3045 Regulation Name: Filler, Bone Void, Calcium Compound Regulatory Class: Class II Product Code: MQV Dated: September 6, 2006 Received: September 8, 2006

Dear Mr. Fitzer:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe 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 for use stated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of pror to ria) 2011-07-11 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). and Ocometier fore, market the device, subject to the general controls provisions of the Act. The r ou may, dierelere, mains 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 If your device 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 r trate be actived a determination that your device complies with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must or mr) vith 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 Cr re rate 077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorni in the quisions of trol 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 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 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. Malkerson

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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#### APPENDIX I

## INDICATIONS FOR USE

510(k) Number (if known): K061311

Allogran-R® Device Name:

Indications For Use:

Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.

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)

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(Division Sega-Off) (Division of Ceneral Secsiorative, and Neurolagical I

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