(158 days)
Not Found
No
The description focuses on the material composition and physical properties of a bone void filler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a bone void filler that resorbs and is replaced by bone during the healing process, and provides osteoconductive support for in-growth of new bone, indicating a therapeutic effect.
No
The device is a bone void filler intended for orthopedic applications to fill gaps and voids in the skeletal system. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a material (powder and liquid components) and includes injection devices, indicating it is a physical product, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure." This describes a device used in the body to fill physical defects, not a device used outside the body to test samples from the body.
- Device Description: The description details a material injected into bone voids and its composition (calcium sulfate, hydroxyapatite, iohexol). This is consistent with a medical device used for structural support and bone regeneration, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gans in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defect smav he surgically created osseous defects or osseous defects from traumatic injury to the bone.
CERAMENT™ (BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.
Product codes
MQV
Device Description
CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate and hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for injection into a bone void/gap. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone. The ceramic bone substitute material is injected into the bone void/gap, under visual inspection or under radiographic monitoring, with the use of the accompanying injection devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive in vitro and in vivo testing has shown that the CERAMENT™|BONE VOID FILLER (A0210 –12 ) meets the requirements of all relevant standards for Calcium Salt Bone Voilt VOID Fillers.
Based on the information provided in this premarket notification, the CERAMENT™|BONE VOID FILLER (A 0210-12 ) is equivaled in this premarket notification : the CERAMENT "JONE VOID FILLER (A of operation of operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
BONE SUPPOR injecting new strength
SEP - 4 2009
510(k) Summary
| Submitter Information | |
|---|---|
| Manufacturer | BONESUPPORT AB |
| Scheelevägen 19 A | |
| Ideon Science Park | |
| SE-223 70 LUND, SWEDEN | |
| Telephone | |
| Company fax | + 46 46 286 53 70 |
- 46 46 286 53 71 |
| Contact person | Ann-Christine Provoost
ann-christine.provoost@bonesupport.com - 46 46 286 53 22 (direct phone) |
| Date of preparation | 9th of June, 2009 |
| Trade name, Classification name, Class, Regulation | |
| Trade Name | CERAMENT™BONE VOID FILLER (A 0210-12) |
| Classification Name | Resorbable calcium salt bone void filler device |
| Class | CLASS II (Special Control) |
| Regulation Number | CFR 888.3045 |
| Product Code | MQV |
Predicate devices
| 510(k) number | Trade name | Manufacturer |
|---|---|---|
| K073316 | CERAMENT™BONE VOID FILLER (A 0210) | BONESUPPORT AB |
Device description
CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate and hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for injection into a bone void/gap. During resorption of the calcium sulfate dihydrate, the
hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone. The ceramic bone substitute material is injected into the bone void/gap, under visual inspection or under
radiographic monitoring, with the use of the accompanying injection devices.
pg 1 of 2
1
BONE
Intended use
CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that not intinue only for of officer only for orthopedic applications as a
filler for gaps and voids that are not intinsic to the bony structure. CE FILLER is indicated the themse oi the stable of the oorly structure. CERAMEN "HBONE VOL
FILLER is indicated into bony voids or gaps in the skeletal system, i.e. extremities, spine (only during a a hysecul in the skelets ystem, i.e. extremities, pelvis
spine (only during open surgety). These defects may be surgically created osseous defects on osseous defects from traumatic injury to the bone.
CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.
Pre-clinical Testing
Summary
Extensive in vitro and in vivo testing has shown that the CERAMENT™|BONE VOID FILLER (A0210 –12 ) meets the requirements of all relevant standards for Calcium Salt Bone Voilt VOID Fillers .
Based on the information provided in this premarket notification, the CERAMENT™|BONE VOID FILLER (A
0210-12 ) is equivaled in this premarket notification : the CERAMENT "JONE VOID FILLER (A
of operation of operation.
19 2 of 2
2
DEPARTMENT OF HEAL.TH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized graphic of an abstract human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
BONESUPPORT AB % Ms. Ann-Christine Provoost Regulatory Affairs Scheelevägen 19A Ideon Science Park SE-223 70 LUND, Sweden
SEP - 4 2009
Re: K090871
Trade/Device Name: CERAMENT™ BONE VOID FIILLER (A0210-12) 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 27, 2009
Dear Ms. Provoost:
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.
3
Page 2 - Ms. Ann-Christine Provoost
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/CDRHQffices/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/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Barbara Buehm
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K090871
Device Name:
CERAMENT™|BONE VOID FILLER (A0210-12)
Indications for Use:
CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gans in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defect smav he surgically created osseous defects or osseous defects from traumatic injury to the bone.
CERAMENT™ (BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lawrence M. Hayes
Bivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090871