CuriOs is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CuriOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. CuriOs is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender in the posterolateral spine. CuriOs should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. In load bearing situations, CuriOs is to be used in conjunction with internal or external fixation devices.

Device Description

CuriOs™ is a micro-structured calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a betatricalcium phosphate and hydroxyapatite. The product is provided sterile.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the CuriOs™ device, does not describe an acceptance criteria table or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

This document pertains to a medical device (bone void filler), not a software product. Therefore, the questions related to AI-specific elements (e.g., test set sample size, ground truth experts, MRMC studies, standalone algorithm performance, training set) are not applicable to the information contained in this submission.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

Physico-chemical properties: Similar composition (beta-tricalcium phosphate and hydroxyapatite).
Pre-clinical testing: Confirmation of similar resorption profile, safety, and biocompatibility.
Intended Use: The CuriOs™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure, and as an autologous bone graft extender.

The "Performance data" section explicitly states: "The CuriOs™ is tested to conform to applicable requirements of the recognized standards. The devices to which the CuriOs™ claims substantial equivalence are Vitoss™ Scaffold (OrthoVita) and OsSatura™ BCP (IsoTis)." This indicates that performance was assessed against established standards relevant to bone void fillers and by comparing it to already approved devices.

Summary based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly detailed as a table in the provided text. The criteria are implied by "applicable requirements of the recognized standards" and demonstration of similar composition, resorption profile, safety, and biocompatibility compared to predicate devices.
Reported Device Performance: The document states that CuriOs™ "confirmed the similar composition, resorption profile, safety, biocompatibility and effectiveness" when compared to predicate devices (Vitoss™ Scaffold and OsSatura™ BCP) through physico-chemical and pre-clinical testing.

The following points are NOT APPLICABLE to this traditional medical device submission:

Sample size used for the test set and the data provenance: N/A (This is not an AI/SaMD study).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (This is not an AI/SaMD study).
Adjudication method for the test set: N/A (This is not an AI/SaMD study).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (This is not an AI/SaMD study).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an AI/SaMD study).
The type of ground truth used: N/A (This is not an AI/SaMD study). For a traditional medical device like this, "ground truth" would be established through established laboratory testing protocols, animal studies, or clinical data (if a clinical study were performed, though none is detailed here beyond "pre-clinical testing").
The sample size for the training set: N/A (This is not an AI/SaMD study).
How the ground truth for the training set was established: N/A (This is not an AI/SaMD study).

In conclusion, this 510(k) submission demonstrates substantial equivalence for a bone void filler by comparing its material properties, safety, and performance to already legally marketed devices, rather than through an AI/software performance study.

Summary

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Koroce il

Progentix 510(k) Premarket Notification CuriOs™

510(K) SUMMARY

5.1

OCT 2 3 2009

SPONSOR
Name:	Progentix Orthobiology BV
Address:	Professor Bronkhorstlaan 10, Building 483723 MB, Bilthoven, The Netherlands
Established Registration Nr:	n/a
Contact person:	Yvonne Bovell, QA/RA Manager
E-mail:	yvonne.bovell@progentix.com
Telephone:	+31 (0)30 2297212
Facsimile:	+31 (0)30 229 7299

5.2 U.S REPRESENTATIVE Name: Address:

Contact person:

Telephone: Facsimile:

Columbia Pharma Consulting Services Inc. 490 NW Datewood Drive Suite 400 Issaquah WA 98027 USA Established Registration Nr: n/a Ed Oliver (425) 557-9990 (425) 313-5620

5.3 DEVICE NAME

Proprietary name: CuriOs™ Common/Usual name: Bone void filler Classification name: Bone void fillers for orthopedics have not been classified (Product Code MQV) (unclassified)

5.4 PREDICATE DEVICES

Vitoss™ Scaffold (OrthoVita), K994337 Proprietary name: OsSatura™ BCP (IsoTis), K030131 Proprietary name:

5.5 DEVICE DESCRIPTION

5.6 INTENDED USE

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Progentix 510(k) Premarket Notification CuriOs™

into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender in the posterolateral spine. CuriOs should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. In load bearing situations, CuriOs is to be used in conjunction with internal or external fixation devices

5.7 TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

CuriOs™ is a synthetic, osteoconductive and resorbable bone void filler comprised of beta-tricalcium phosphate and hydroxyapatite. CuriOs™ has a trabecular structure that resembles the structure of human cancellous bone. The osteoconductive nature of CuriOs™ guides the regeneration of new bone following its implantation into the defect site. The ceramic implant resorbs and is replaced by bone and soft tissue during the natural process of bone remodeling.

The safety and effectiveness of the CuriOs™ bone void filler is adequately supported by the substantial equivalence information, safety and performance data provided in this Premarket Notification. CuriOs™ and the predicate devices are essentially similar in design, materials of construction and function. They all have the same intended use. CuriOs™ has been compared in physico-chemical and pre-clinical testing with the predicate devices, which confirmed the similar composition, resorption profile, safety, biocompatibility and effectiveness. The safety and biocompatibility testing performed for calcium phosphates in general, and the long history of safe clinical use for these materials further support the safe use of CuriOs™. CuriOs™ meets the applicable requirements of the FDA guidance documents on bone void fillers.

5.8 Performance data

The CuriOs™ is tested to conform to applicable requirements of the recognized standards. The devices to which the CuriOs™ claims substantial equivalence are Vitoss™ Scaffold (OrthoVita) and OsSatura™ BCP (IsoTis).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, which is often associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Progentix Orthobiology BV % Ms. Yvonne Bovell Professor Bronkhorstlaan 10, Building 48 Bilthoven Netherlands 3723 MB

Re: K090641

Trade/Device Name: CuriOs Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 24, 2009 Received: August 25, 2009

OCT 2 3 2009

Dear Ms. Bovell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deternined 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 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 device-related adverse events) (21 CFR 803); 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 - Ms. Yvonne Bovell

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Progentix 510(k) Premarket Notification CuriOs™

INDICATIONS FOR USE STATEMENT 4.

Indications For Use

510(k) Number (if Known): K090641

Device Name: CuriOs™ Indications for Use: CuriOs is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CuriOs is indicated for use in the treatment of surqically created osseous defects or osseous defects resulting from traumatic injury to the bone. CuriOs is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender in the posterolateral spine. CuriOs should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. In load bearing situations, CuriOs is to be used in conjunction with internal or external fixation devices.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of C Office of Device Evaluation (ODE

Younny L. May FOR M. MELKERSON

(Division Sign-Off) (Division Sign-of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090641

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.