(130 days)
No
The description focuses on the material properties and surgical application of a bone graft substitute, with no mention of AI or ML.
Yes
The device is a bone void filler intended for orthopedic applications to fill gaps and voids in the skeletal system, which directly addresses medical conditions and aids in the healing process of bone, thereby providing a therapeutic effect.
No
Explanation: The device is a bone void filler intended for orthopedic applications, not for diagnosing medical conditions. It is used to fill gaps and voids in the skeletal system.
No
The device is a physical bone graft substitute material consisting of powder and liquid components, intended for filling bone voids. It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure." It is used in vivo (within the body) to fill bone defects and support bone healing.
- Device Description: The description details the composition of the material and how it is used surgically to fill bone voids.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device is a therapeutic and structural support material used directly within the body during surgery.
N/A
Intended Use / Indications for Use
CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended 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, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.
CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.
CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
CERAMENT| BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains iohexol as a radio-opacification enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo.
By combining hydroxyapatite and calcium sulfate, an optimal balance is achieved between implant resorption rate and bone ingrowth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone ingrowth and gives long term structural support to the newly formed bone.
The ceramic bone graft substitute is placed into the bone defect under direct visualization or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate filling the bone defect.
When fully set in vivo, CERAMENT | BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic monitoring
Anatomical Site
skeletal system, i.e. extremities, pelvis, and posterolateral spine
Indicated Patient Age Range
adults and pediatric patients ≥ 9 years old
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)
The previously provided performance testing demonstrates the substantial equivalence of CERAMENT| BONE VOID FILLER. The prior testing was conducted in accordance with the Guidance for Industry and FDA Staff (Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device; Guidance for Industry and FDA (issued June 2, 2003)).
Additional testing has been conducted to demonstrate that CERAMENT | BONE VOID FILLER can be used to augment hardware and support bone fragments during a surgical procedure, and that the material can be drilled and screws placed through it.
Biocompatibility testing: Previously conducted biocompatibility testing demonstrates that CERAMENT | BONE VOID FILLER is biocompatible.
Conclusions: Based on the information provided in this premarket notification, CERAMENT| BONE VOID FILLER is substantially equivalent to the predicate device in intended use, materials, technological characteristics, principles of operation, and function. Testing and engineering analyses showed that CERAMENT | BONE VOID FILLER met the pre-determined acceptance criteria identified in the Design Control Activities Summary. Additionally, CERAMENT | BONE VOID FILLER is in compliance with pyrogenicity testing requirements for orthopedic implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K090871, K132656, K113871, K102722
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
October 16, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
BoneSupport AB Blerta Shuka Regulatory Affairs Specialist Scheelevagen 19. Ideon Science Park Lund. SE 223-70 Sweden
Re: K201535
Trade/Device Name: CERAMENT BONE VOID FILLER Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: June 8, 2020 Received: June 8, 2020
Dear Blerta Shuka:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201535
Device Name CERAMENT BONE VOID FILLER
Indications for Use (Describe)
CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended 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, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.
CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.
CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.
| 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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3
510(k) Summary
| Manufacturer: | BONESUPPORT AB
Scheelevägen 19
IDEON Science Park
SE-223 70 LUND, SWEDEN
- 46 46 286 53 70 |
|----------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Blerta Shuka
blerta.shuka@bonesupport.com - 46 70 330 27 68 (direct phone) |
| Prepared by: | MCRA, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
+1.202.552.5800 |
| Date prepared: | October 9, 2020 |
Device Information
| Trade Name: | CERAMENT BONE VOID FILLER |
|---|---|
| Common Name: | Bone void filler |
| Classification Name: | Resorbable calcium salt bone void filler device |
| Regulation: | 21 CFR 888.3045 |
| Regulatory Class: | II |
| Product Code: | MQV |
Device Description
CERAMENT| BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains iohexol as a radio-opacification enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo.
By combining hydroxyapatite and calcium sulfate, an optimal balance is achieved between implant resorption rate and bone ingrowth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone ingrowth and gives long term structural support to the newly formed bone.
4
The ceramic bone graft substitute is placed into the bone defect under direct visualization or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate filling the bone defect.
When fully set in vivo, CERAMENT | BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.
Indications for Use
CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended 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, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.
CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.
CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.
| 510(k)
| number | Trade name | Manufacturer | Predicate |
|---|---|---|---|
| K073316 | CERAMENT BONE VOID FILLER | Bonesupport AB | Primary predicate |
| K090871 | CERAMENT BONE VOID FILLER | ||
| (High Contrast) | Bonesupport AB | Reference device | |
| K132656, | |||
| K113871 | PRO-DENSE Bone Graft Substitute | Wright Medical | |
| Technology, Inc. | Reference device | ||
| K102722 | Norian Drillable Inject and Norian | ||
| Drillable Fast Set Putty | Synthes | Reference device |
Predicate Devices
Comparison of Technological Characteristics with the Predicate Device
The table below summarizes the differences between the technological characteristics of the primary predicate device (CERAMENT) BONE VOID FILLER, K073316) and the subject device.
5
| Feature | Any difference between the primary predicate device
and the new device |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Powder component | No difference |
| Liquid component | No difference |
| Mixing of paste | No difference |
| Delivery of paste to patient | Two plastic Tip Extenders have been added to the device.
They may be connected to the CERAMENT ID to
facilitate paste injection |
| Indications | Indications have been expanded to include use in:
• filling benign bone cysts and tumors in adults and
pediatric patients ≥ 9 years old,
• augmenting hardware and supporting bone fragments
during a surgical procedure, and
• ability to drill and place screws through the material. |
Table 1. Comparison between the device and its primary predicate device (CERAMENT | BONE VOID FILLER, K073316)
Performance Testing
The previously provided performance testing demonstrates the substantial equivalence of CERAMENT| BONE VOID FILLER. The prior testing was conducted in accordance with the Guidance for Industry and FDA Staff (Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device; Guidance for Industry and FDA (issued June 2, 2003)).
Additional testing has been conducted to demonstrate that CERAMENT | BONE VOID FILLER can be used to augment hardware and support bone fragments during a surgical procedure, and that the material can be drilled and screws placed through it.
Biocompatibility
Previously conducted biocompatibility testing demonstrates that CERAMENT | BONE VOID FILLER is biocompatible.
Conclusions
Based on the information provided in this premarket notification, CERAMENT| BONE VOID FILLER is substantially equivalent to the predicate device in intended use, materials, technological characteristics, principles of operation, and function. Testing and engineering analyses showed that CERAMENT | BONE VOID FILLER met the pre-determined acceptance criteria identified in the Design Control Activities Summary. Additionally, CERAMENT | BONE VOID FILLER is in compliance with pyrogenicity testing requirements for orthopedic implants.