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 Description

Synthetic bone graft granules of one of the following three materials packed in a multi-purpose applicator (MPA):
(A) 100% pure hydroxylapatite (TriPore HA)
(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calcium phosphate (TriPore BP90)
(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calcium phosphate (TriPore BP15)

AI/ML Overview

I'm sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for a medical device (synthetic bone graft) and primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general information about the device. It does not describe any specific study that proves the device meets acceptance criteria, define acceptance criteria, or provide details about a performance study with sample sizes, expert involvement, adjudication, or ground truth establishment.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Orthogem. K150064.

510(k) Summary

Submitter/Owner	Orthogem LimitedBioCityPennyfoot StreetNottinghamNN1 1GFUnited 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:A) hydroxyapatiteB) biphasic tri-calcium phosphate:hydroxyapatite.Nominal composition 90:10C) biphasic tri-calcium phosphate:hydroxyapatite.Nominal composition15:85
Classification	Resorbable calcium salt bone void filler devices have been classified bythe Orthopedics Device Panel as Class II Special Controls per 21 CFR888.3045.Product code: MQV
Predicate Devices	TriPore (K070132)TriPore TDD (K110787)
Device Description	Synthetic bone graft granules of one of the following three materialspacked in a multi-purpose applicator (MPA):(A) 100% pure hydroxylapatite (TriPore HA)(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calciumphosphate (TriPore BP90)(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calciumphosphate (TriPore BP15)
Indications for Use	TriPore HA, TriPore BP90 and TriPore BP15 is synthetic bone graftintended to be packed into bone defects of the skeletal system(extremities, spine or pelvis) which are not intrinsic to the stability ofthe bony structure. These defects may be surgically created voids orfrom traumatic injury to the bone. The device gradually resorbs and isreplaced with bone during the healing process. Rigid fixationtechniques should be used in conjunction with this device.
TechnicalCharacteristics andSubstantialEquivalence	TriPore HA, TriPore BP90 and TriPore BP15 is precisely the same asthe predicate device, K070132. When TriPore granules are packed intoan applicator, it performs exactly the same function as applicator inthe predicate in K110787. The sole difference is the materials andprocessing used to manufacture the applicator.
Determination ofsubstantialequivalence (non-clinical data)	Orthogem has determined that TriPore in this application issubstantially equivalent to the predicate device on the basis of designverification of the applicator.
Determination ofsubstantialequivalence (clinicaldata)	No clinical data were submitted. The synthetic bone graft granules areunchanged in composition and manufacture from the predicate device.
Conclusions	Orthogem concludes that the verifications carried out on TriPore in adelivery device demonstrate that it is safe, effective, and performs aswell or better than the predicate device.
Other informationdeemed necessary bythe FDA	None.
Summary verificationstatement	The submitter has verified that this summary includes onlyinformation that is also contained in the body of the 510(k). Thissummary does not contain any:- puffery or unsubstantiated labeling claims- raw data (that is, contains only summary data)- trade secret or confidential information- patient identification information

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

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
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.(b)
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.