K Number
K071004
Device Name
OSTEOCRETE BONE VOID FILLER
Date Cleared
2009-05-21

(773 days)

Product Code
Regulation Number
888.3045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or 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. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Device Description
OsteoCrete™ is an injectable, moldable, and biocompatible Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
More Information

Not Found

No
The summary describes a bone void filler material and its intended use, with no mention of AI or ML technology in its function, description, or performance studies.

Yes.
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process, intended for bony voids or defects to aid the healing of the skeletal system.

No

The device is a bone void filler intended for structural support and healing, not for diagnosing medical conditions.

No

The device description clearly states it is an injectable, moldable, and biocompatible Bone Void Filler consisting of powder and a mixing solution, packaged with mixing and administration tools. This describes a physical medical device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that OsteoCrete™ Bone Void Filler is for filling bony voids or defects in the skeletal system. This is a therapeutic and structural purpose, not a diagnostic one.
  • Device Description: The description details a material (powder and mixing solution) that is injected or placed into the body to fill a physical space. This is consistent with a medical device used for treatment or repair, not for analyzing samples from the body to diagnose a condition.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
  • Performance Studies: The performance studies mentioned are related to the device's physical properties and biological interaction (resorption and replacement with bone), which are relevant to its function as a bone void filler, not as a diagnostic tool.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. OsteoCrete™ does not fit this description.

N/A

Intended Use / Indications for Use

Bone Solutions, Inc. OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or 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. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Product codes

MQV

Device Description

OsteoCrete™ is an injectable, moldable, and biocompatible Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

skeletal system (the long bone and pelvis)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

OsteoCrete™ Bone Void Filler was subjected to performance testing (bench and animal) in accordance with the FDA Guidance Document, "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler; Guidance for Industry and FDA." The testing confirmed substantial equivalence to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K011897, K041842, K051406, K051951

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92

| Submitted by: | Bone Solutions, Inc.
9400 N. Central Expressway, Suite 1250, L.B.103
Dallas, TX 75231 USA
Phone: 214-762-8066
Tony Copp, Ph.D., COO
email: copp@bonesolutionsinc.com
Fax: 800-417-8196 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person for premarket notification:
Christine Emanuel, Regulatory Consultant
1205 De La Vina Street
Santa Barbara, CA 93101
Phone: 805.963.4312
Fax: 805.564.8642
Email: cemanuel@west.net |
| Date Prepared: | May 4, 2009 |
| Proprietary Name: | OsteoCrete™ Bone Void Filler |
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification: | Class II, MQV, 21 CFR 888.3045 |
| Predicate Devices: | Synthes (USA). Norian SRS Bone Void Filler, 510(k) number
K011897
Synthes (USA). Norian SRS Fast Set Putty, 510(k) number
K041842
Futura Biomedical. OsteoCure Resorbable Bead Kit, 510(k)
number K051406
Bone Support AB. Cerament Bone Void Filler, 510(k)
number K051951 |
| Device Description: | OsteoCrete™ is an injectable, moldable, and biocompatible
Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet
contains powder (Magnesium based compound) and a mixing
solution (Buffered saline). It is a sterile, single use device,
packaged with mixing and administration tools. |
| Indication for Use: | Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is
intended only for bony voids or defects that are not intrinsic to |

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OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bones and pelvis). These defects may be surgically created osseous defects or 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.

OsteoCrete™ Bone Void Filler was subjected to performance testing Performance Data: (bench and animal) in accordance with the FDA Guidance Document, "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler; Guidance for Industry and FDA." The testing confirmed substantial equivalence to the predicate device.

Image /page/1/Picture/2 description: The image shows the text "Page 2 of 2" written in cursive. The word "Page" is written with a capital "P" and the number "2" is written in numerical form. The words "of" and the second "2" are smaller in size compared to the word "Page".

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bone Solutions Incorporated % Mr. Tony Copp Director, Executive Vice President, Chief Operating Officer 9400 North Central Expressway, Suite 1250 Dallas, Texas 75231

MAY 2 1 2009

Re: K071004

Trade/Device Name: OsteoCrete™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 26, 2008 Received: August 28, 2008

Dear Mr. Copp:

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.

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- Mr. Tony Copp

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milliken

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

Enclosure

4

Request for additional information from the FDA to Bone Solutions regarding K071004.

Indications for Use

510(k) Number (if known): K071004

Device Name: Bone Solutions, Inc. OsteoCrete™ Bone Void Filler

Indications for Use:

Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or 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. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millman

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

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