GranOSTM - beta tricalcium phosphate synthetic bone granules

K143692 · Tcm Associates, Ltd. · MQV · Aug 21, 2015 · Orthopedic

Device Facts

• Record ID: K143692
• Device Name: GranOSTM - beta tricalcium phosphate synthetic bone granules
• Applicant: Tcm Associates, Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, 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

GranOS is a synthetic, porous, resorbable osteoconductive scaffold composed of beta tricalcium phosphate granules. It is used as a bone void filler to treat non-structural bony defects in the extremities, spine, and pelvis. The device is manually placed by a surgeon into the defect site. Once implanted, the scaffold acts as a matrix for new bone growth, gradually resorbing and being replaced by natural bone during the healing process. It is intended for single-use in a clinical or surgical setting.

Clinical Evidence

Bench testing only. Compliance with ASTM F1088-04a (Standard Specification for beta tricalcium phosphate for Surgical Implantation) was demonstrated. No clinical data was provided.

Technological Characteristics

Material: Beta tricalcium phosphate (Ca3(PO4)2) meeting ASTM F 1088-04a (2010). Structure: Porous scaffold with interconnected porosity (~70%) and pore sizes <1-700μm. Form factor: Granules (250-500μm, 1-2.8mm, 2-4mm). Sterilization: Gamma radiation (SAL 10^-6). Single-use.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, posterolateral spine, pelvis) resulting from surgery or traumatic injury, where the defect is not intrinsic to the stability of the bony structure.

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

• βGran® Synthetic Osteoconductive Scaffold (K041616)
• Cerasorb® ORTHO (K014156)
• Vitoss® Scaffold Synthetic Cancellous Bone Void Filler (K032409)

Submission Summary (Full Text)

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

August 21, 2015

TCM Associates Ltd Mr. Iain Alligan Technical Director 3 Hillgrove Business Park Nazeing Road Essex EN9 2HB United Kingdom

Re: K143692

Trade/Device Name: GranOS - beta tricalcium phosphate synthetic bone granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: July 13, 2015 Received: July 23, 2015

Dear Mr. Alligan:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143692

#### Device Name

GranOSTM - beta tricalcium phosphate synthetic bone granules

#### Indications for Use (Describe)

GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Type of Use (Select one or both, as applicable)

| <span style="unicode-bidi:embed;"></span> <span style="font-size:11pt;">Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-----------------------------------------------------------------------------------------------------------------------------|
| <span style="unicode-bidi:embed;"></span> <span style="font-size:11pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# Section 5

# Premarket Notification 510(k) Summary

beta tricalcium phosphate synthetic bone granules (Trade Name: GranOS™)

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## 5.1 Premarket Notification 510(k) Summary

GranOS™ - beta tricalcium phosphate synthetic bone granules

(per 21 CFR 807.92)

| Submitter (Owner) | TCM Associates Ltd<br>3 Hillgrove Business Park<br>Nazeing Road<br>Nazeing<br>Essex<br>EN9 2HB<br>United Kingdom |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Iain Alligan, Technical Director<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared | 20th August 2015 |
| Trade Name | GranOS™ - beta tricalcium phosphate synthetic bone granules |
| Common Name | Synthetic bone void filler |
| Device Classification | Resorbable calcium salt bone void filler device |
| Regulation | Class II Special Controls as per 21 CFR 888.3045 |
| Device Product Code | MQV |
| Legally Marketed<br>Predicate Devices | βGran® Synthetic Osteoconductive Scaffold (K041616)<br>Cerasorb® ORTHO (K014156)<br>Vitoss® Scaffold Synthetic Cancellous Bone Void Filler K032409 |
| Device Description | GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure<br>beta tricalcium phosphate granules for use in the repair of bony defects. |
| Intended Use | GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the<br>bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal<br>system (i.e. the extremities, posterolateral spine, and pelvis). These defects may be surgically created<br>osseous defects or osseous defects created from traumatic injury to the bone. The product provides<br>bone void filler that resorbs and is replaced with bone during the healing process |

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| 510k (Traditional) Premarket Submission | TCM Associates Ltd | | |
|-----------------------------------------|-------------------------------------------------------------|-------------|------------|
| Device: | GranOS™ - beta tricalcium phosphate synthetic bone granules | Issue: | 03 |
| Classification: | Resorbable calcium salt bone void filler device | Issue Date: | 20.08.2015 |
| Page Title: | Section 5: Premarket Notification 510(k) Summary | | |

| Technological Characteristics - Comparison to Predicates and Substantial Equivalence | |
|--------------------------------------------------------------------------------------|--|
| | |

| Trade Name | GranOS™ - beta<br>tricalcium phosphate<br>synthetic bone granules | βGran® synthetic<br>osteoconductive scaffold | Cerasorb® ORTHO | Vitoss® Scaffold<br>Synthetic Cancellous<br>Bone void Filler |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 510(k)<br>Registration No: | K143692 | K041616 | K014156 | K032409 |
| Chemical<br>composition of the<br>material | beta tricalcium phosphate<br>Ca3(PO4)2 meeting the<br>requirements of<br>ASTM F 1088-04a (2010) | beta tricalcium phosphate<br>Ca3(PO4)2 meeting the<br>requirements of<br>ASTM F 1088-04a (2010) | beta tricalcium phosphate<br>Ca3(PO4)2 meeting the<br>requirements of ASTM F<br>1088-04a (2010) | beta tricalcium phosphate<br>Ca3(PO4)2 meeting the<br>requirements of<br>ASTM F 1088-04a (2010) |
| Patient Population | Individuals with bony<br>defects resulting from<br>surgery or trauma | Individuals with bony defects<br>resulting from surgery or<br>trauma | Patients with bone voids<br>or gaps caused by surgery<br>trauma or degeneration | Individuals with bony<br>defects resulting from<br>surgery or trauma |
| Anatomical<br>Locations | To be packed into the<br>irregular shaped bony voids<br>of the skeletal system i.e.<br>extremities, spine and pelvis | Bony voids or gaps of the<br>skeletal system i.e. the<br>extremities, spine and pelvis | Skeletal system<br>extremities, spine and<br>pelvis | Bony voids or gaps of the<br>skeletal system i.e. the<br>extremities, spine and<br>pelvis |
| Physical Structure<br>of the Material | Interconnected porosity | Interconnected porosity | Interconnected porosity | Trabecular structure<br>similar to cancellous<br>bone |
| Porosity | Approximately 70% | Approximately 70% | Approximately 60% - 70% | Approximately 90% |
| Pore Size (range) | Micropores <1 - 700μm | Micropores <1 - 700μm | Micropores >0<80 μm | 1-1000 μm |
| Performance | | | | |
| Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive | Osteoconductive |
| Sterility | Sterilised by Gamma<br>Radiation, single use only.<br>Sterility Assurance Level<br>(SAL) of 1 x 10-6 | Sterilised by Gamma<br>Radiation, single use only.<br>Sterility Assurance Level<br>(SAL) of 1 x 10-6 | Sterilised by Gamma<br>Radiation, single use only.<br>Sterility Assurance Level<br>(SAL) of 1 x 10-6 | Sterilised by Gamma<br>Radiation, single use<br>only. Sterility Assurance<br>Level (SAL) of 1 x 10-6 |
| Biocompatibility | Established | Established | Established | Established |
| Presentation | Granule Sizes<br>250-500μm<br>1 – 2.8mm<br>2 – 4mm | Granule Sizes<br>250-500μm<br>1 – 2.8mm<br>2 – 4mm | Granules and Blocks<br>500 - 1000μm<br>1000 - 2000μm | Morsels 1-4mm and<br>cylinders 9 x 23mm |

Results of non-clinical performance tests has demonstrated that GranOS™ - beta tricalcium phosphate granules have the same critical specification (i.e. chemistry, crystallinity, physical form, porosity, dissolution/solubility) and the same intended use as the predicate device.

Key requirements and recommendations have also been met within The Class II Special Controls Guidance: Document Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.

## Non-clinical testing

GranOS™ - beta tricalcium phosphate granules have been tested and shown to be in compliance to the following recognised performance standard: ASTM F1088-04a 2010 - Standard Specification for beta tricalcium phosphate for Surgical Implantation. In addition, GranOS™ - beta tricalcium phosphate granules have the same Contraindications, Instructions, Warnings, Precautions and possible adverse reactions/complications when directly compared to the predicate devices and so does not raise new questions regarding safety and effectiveness and therefore substantial equivalence is claimed under Section 513(i) of the FD&C Act (21 U.S.C. § 360c(i)).

## [21CFR 807.92(b)(1) and 21CFR 807.92(b)(2])

## Conclusion

Based on the results of the non-clinical testing and the clinical evaluation of the product, we conclude that GranOS™ - beta tricalcium phosphate granules are as safe, as effective, and performs as well as or better than the predicate device.

## [21CFR 807.92(b)(3)