Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)

K150064 · Orthogem, Ltd. · MQV · Sep 4, 2015 · Orthopedic

Device Facts

• Record ID: K150064
• Device Name: Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
• Applicant: Orthogem, Ltd.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the sketal system (extremities, posterolateral spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Device Story

Synthetic bone graft granules (hydroxyapatite or biphasic tri-calcium phosphate/hydroxyapatite) provided in multi-purpose applicator (MPA). Device packed into non-structural bone voids (extremities, spine, pelvis) by surgeons. Granules resorb over time, replaced by natural bone during healing. Rigid fixation required. Applicator facilitates delivery of granules to defect site. Benefits include bone void filling and osteoconductive scaffold for healing.

Clinical Evidence

No clinical data submitted. Substantial equivalence based on design verification of the applicator and identical composition/manufacture of bone graft granules to predicate devices.

Technological Characteristics

Synthetic bone graft granules: 100% hydroxyapatite, 90:10 hydroxyapatite/tri-calcium phosphate, or 15:85 hydroxyapatite/tri-calcium phosphate. Delivered via multi-purpose applicator. Resorbable calcium salt bone void filler. Class II device.

Indications for Use

Indicated for patients with surgically created or traumatic bone defects in the extremities, posterolateral spine, or pelvis that are not intrinsic to bony structure stability. Contraindicated for use in load-bearing applications requiring structural stability; must be used with rigid fixation.

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

• TriPore (K070132)
• TriPore TDD (K110787)

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

September 4, 2015

Orthogem Ltd. % Mr. Rod Ruston Priory Analysts Ltd. 15 Rudchesters Milton Keynes BG MK13 0PH United Kingdom

Re: K150064

Trade/Device Name: Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 15, 2015 Received: July 20, 2015

Dear Mr. Ruston:

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

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(21 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 (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/Resourcesfor You/Industry/default.htm. 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 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

510(k) Number (if known) K150064

Device Name

Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)

Indications for Use (Describe)

TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the sketal system (extremities, posterolateral spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2.66663H2.66667C1.93333 2.66663 1.33333 3.26663 1.33333 3.99996V13.3333C1.33333 14.0666 1.93333 14.6666 2.66667 14.6666H13.3333C14.0667 14.6666 14.6667 14.0666 14.6667 13.3333V3.99996C14.6667 3.26663 14.0667 2.66663 13.3333 2.66663ZM6.66667 11.3333L2.66667 7.33329L3.5 6.49996L6.66667 9.66663L12.5 3.83329L13.3333 4.66663L6.66667 11.3333Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="12" rx="0.666667" stroke="black" stroke-width="1.33333" width="13.3333" x="1.33325" y="2.66663"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### Orthogem. K150064.

## 510(k) Summary

| Submitter/Owner | Orthogem Limited<br>BioCity<br>Pennyfoot Street<br>Nottingham<br>NN1 1GF<br>United Kingdom |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 011 44 115 950 5721 |
| Facsimilie | 011 44 115 950 5921 |
| Contact Person | Rod Ruston BSc FRAPS |
| Date Prepared | 23 September 2014 |
| Trade Name | TriPore in a delivery device |
| Common Name | Synthetic, porous, bone graft granules of:<br>A) hydroxyapatite<br>B) biphasic tri-calcium phosphate:hydroxyapatite.<br>Nominal composition 90:10<br>C) biphasic tri-calcium phosphate:hydroxyapatite.<br>Nominal composition15:85 |
| Classification | Resorbable calcium salt bone void filler devices have been classified by<br>the Orthopedics Device Panel as Class II Special Controls per 21 CFR<br>888.3045.<br>Product code: MQV |
| Predicate Devices | TriPore (K070132)<br>TriPore TDD (K110787) |
| Device Description | Synthetic bone graft granules of one of the following three materials<br>packed in a multi-purpose applicator (MPA):<br>(A) 100% pure hydroxylapatite (TriPore HA)<br>(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calcium<br>phosphate (TriPore BP90)<br>(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calcium<br>phosphate (TriPore BP15) |
| Indications for Use | TriPore HA, TriPore BP90 and TriPore BP15 is synthetic bone graft<br>intended to be packed into bone defects of the skeletal system<br>(extremities, spine or pelvis) which are not intrinsic to the stability of<br>the bony structure. These defects may be surgically created voids or<br>from traumatic injury to the bone. The device gradually resorbs and is<br>replaced with bone during the healing process. Rigid fixation<br>techniques should be used in conjunction with this device. |
| Technical<br>Characteristics and<br>Substantial<br>Equivalence | TriPore HA, TriPore BP90 and TriPore BP15 is precisely the same as<br>the predicate device, K070132. When TriPore granules are packed into<br>an applicator, it performs exactly the same function as applicator in<br>the predicate in K110787. The sole difference is the materials and<br>processing used to manufacture the applicator. |
| Determination of<br>substantial<br>equivalence (non-<br>clinical data) | Orthogem has determined that TriPore in this application is<br>substantially equivalent to the predicate device on the basis of design<br>verification of the applicator. |
| Determination of<br>substantial<br>equivalence (clinical<br>data) | No clinical data were submitted. The synthetic bone graft granules are<br>unchanged in composition and manufacture from the predicate device. |
| Conclusions | Orthogem concludes that the verifications carried out on TriPore in a<br>delivery device demonstrate that it is safe, effective, and performs as<br>well or better than the predicate device. |
| Other information<br>deemed necessary by<br>the FDA | None. |
| Summary verification<br>statement | The submitter has verified that this summary includes only<br>information that is also contained in the body of the 510(k). This<br>summary does not contain any:<br>- puffery or unsubstantiated labeling claims<br>- raw data (that is, contains only summary data)<br>- trade secret or confidential information<br>- patient identification information |

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### Orthogem. K150064 510(k) Summary – continued from previous page