DB-EZ Bone Void Filler

K212353 · Dimensional Bioceramics, LLC · MQV · Sep 22, 2021 · Orthopedic

Device Facts

• Record ID: K212353
• Device Name: DB-EZ Bone Void Filler
• Applicant: Dimensional Bioceramics, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Sep 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DB-EZ Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Story

DB-EZ Bone Void Filler is a pre-mixed, moldable, biocompatible putty/paste used to fill non-structural bony voids or gaps in the skeletal system (extremities and pelvis). The device consists of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer. It is supplied in 5 cc and 10 cc kits, sterilized by E-beam. During surgery, the clinician applies the putty to the defect site. The material is self-setting, hardening in an aqueous environment at 37°C. Once implanted, the device acts as an osteoconductive scaffold, resorbing over time and being replaced by new bone through cell-mediated remodeling. It is intended for single use only.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included working time, setting time, heavy metal analysis (ICP-MS), pH profile, FTIR, XRD crystallographic analysis, temperature profile, solubility/dissolution, tensile testing, dimensional stability, SEM physical form analysis, and bacterial endotoxin testing (USP <85>, USP <161>).

Technological Characteristics

Resorbable calcium phosphate bone void filler in PEG-based polymer. Self-setting, isothermic reaction. Hardens to hydroxyapatite. Porosity ~41.1%, density 1.79 gm/cc. Pore size 0.04 microns. Sterilized by E-beam (SAL 10^-6). Heavy metal analysis per ASTM F1185-03.

Indications for Use

Indicated for individuals with bony defects resulting from surgery, trauma, or degeneration in the skeletal system (extremities and pelvis). Indicated only for non-structural bony voids or gaps not intrinsic to the stability of the bony structure.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Skeletal Kinetics, SKaffold NMX Bone Void Filler (K132211)

Reference Devices

• Dimensional Bioceramics, DB-Composite Bone Void Filler (K210193)

Submission Summary (Full Text)

{0}------------------------------------------------

September 22, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized depiction of a human figure. To the right of the HHS logo is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Dimensional Bioceramics, LLC. % Patsy J. Trisler, J.D., RAC Regulatory Consultant Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K212353

Trade/Device Name: DB-EZ 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: July 22, 2021 Received: July 29, 2021

Dear Ms. Trisler:

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laura C. Rose -S

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) K212353

Device Name

DB-EZ Bone Void Filler

### Indications for Use (Describe)

DB-EZ Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## Section 5

## 510(k) Summary

#### l. SUBMITTER

| Submitter Name | Dimensional Bioceramics, LLC |
|--------------------------------|-------------------------------------------------------|
| Submitter Address | 2161 Delaware Avenue, Suite A<br>Santa Cruz, CA 95060 |
| Contact Person<br>Phone Number | Duran N. Yetkinler, M.D., Ph.D.<br>408-757-6603 |

July 22, 2021

#### ll. DEVICE

| Trade Name | DB-EZ Bone Void Filler |
|------------------|-------------------------------------------------|
| Common Name | Bone Void Filler |
| Classification | Resorbable Calcium Salt Bone Void Filler Device |
| Name Number | 21 CFR 888.3045 |
| Product Code | MQV |
| Regulatory Class | Class 2 |

#### lll. PREDICATE DEVICE

Date Prepared

| Predicate Device | K132211, Skeletal Kinetics, SKaffold NMX Bone<br>Void Filler |
|------------------|--------------------------------------------------------------------|
| Reference Device | K210193, Dimensional Bioceramics,<br>DB-Composite Bone Void Filler |

#### INDICATIONS FOR USE IV.

This submission has identical indications for use as the predicate device, Skeletal Kinetics SKaffold NMX Bone Void Filler (K132211).

DB-EZ Bone Void Filler is Indicated to fill bony voids Indications For Use Statement or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.

{4}------------------------------------------------

#### V. DEVICE DESCRIPTION

| Device Identification<br>and Technological<br>Characteristics | DB-EZ Bone Void Filler is a pre-mixed moldable and<br>biocompatible putty/paste bone void filler. DB-EZ<br>consists of a mixture of calcium phosphate powder<br>in a bioinert polyethylene glycol (PEG) based<br>polymer that resorbs and is replaced with bone<br>during the healing process. |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Device Sizes and The 5 cc and 10 cc DB-EZ kits are provided sterile Sterility Information to SAL 10-6 and are for single use only.

#### VI. PERFORMANCE TESTING

Testing Summary: The following testing was performed on the predicate device and presented in the K132211 documentation.

| Test | Test Method Summary |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Working Time In<br>Vitro | Ensures sufficient manipulation time is provided while also<br>ensuring setting times are met it the operative theater. |
| Setting Time | Measures the time for a bone void filler to set in simulated<br>physiologic conditions. |
| Heavy Metal<br>Analysis | Samples are analyzed for trace heavy metal content using<br>ICP-MS according to ASTM F1185-03. |
| pH Profile | Examines effects of the device on pH surrounding the<br>implanted device. pH is measured in physiologic buffer<br>solution proximal to curing cement. |
| FTIR Analysis | This test identifies the chemical composition of subject and<br>predicate device following curing in simulated physiologic<br>conditions. |
| Crystallographic<br>Analysis | XRD analysis is performed with samples set in simulated<br>physiologic conditions for specified times and evaluated using<br>powder x-ray diffraction and compared against known<br>mineralogic standards. |
| Temperature<br>Profile | Device samples are tested in simulated physiologic solution<br>to measure temperature of curing cement. |
| Solubility and<br>Dissolution | Test samples are cured and incubated at simulated<br>physiological conditions for a specified time and measured for<br>solubility and dissolution. |
| Tensile Testing | Test samples were mixed and cured for 24 hours at simulated<br>physiological conditions for a specified time and measured for<br>solubility and dissolution. |

{5}------------------------------------------------

| Test | Test Method Summary |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensional<br>Stability | Dimensional stability is measured to establish that the bone<br>void fillers maintain shape and do not dissolve in an untimely<br>manner. |
| Physical Form | Test samples were imaged by SEM to determine<br>microstructure. Testing confirmed hydroxyapatite crystal<br>formation. |
| Biocompatibility | No new biocompatibility studies were needed to confirm<br>biocompatibility and demonstrate substantial equivalence,<br>because no changes to the product were made from the<br>identical predicate device. |
| Sterilization and<br>Shelf Life | The product is sterilized by E-beam to a SAL of $10^{-6}$ . Product<br>is real time shelf life tested to one year. |
| Bacterial<br>Endotoxins | Testing, according to USP<85> and USP<161>, showed the<br>product meets the acceptance limit of 20EU/device. |
| Animal Testing | No new animal studies were needed to demonstrate<br>substantial equivalence, since the subject device is identical<br>to the predicate device. |
| Clinical Testing | This product category does not require human clinical testing. |

### VII. SUBSTANTIAL EQUIVALENCE COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Please refer to the SE Comparison Table below.

DB-EZ Bone Void Filler's intended use and critical specifications are substantially equivalent to the predicate device. Skeletal Kinetics SKaffold NMX (K132211). Further, this product is composed of the same material, and is manufactured and packaged by the same processes and core staff members as the predicate device. The only difference is the subject device is manufactured in a different facility than the predicate device.

There are no notable differences in comparison to the predicate device, therefore no questions related to safety and efficacy were raised.

#### CONCLUSIONS VIII.

Based on the comparisons provided and the information included in this 510(k), it can be concluded that DB-EZ Bone Void FIller is substantially equivalent to the predicate device Skeletal Kinetics SKaffold NMX (K132211).

{6}------------------------------------------------

# SUBSTANTIAL EQUIVALENCE COMPARISON

| Parameter | Predicate Device | Subject Device | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Trade Name | SKaffold NMX | DB-EZ Bone Void Filler | | |
| 510(K) # | K132211 | K212353 | | |
| Common Name | Bone Void Filler | Bone Void Filler | | |
| Intended Use | A non-structural bone void filler for<br>osseous defects | A non-structural bone void filler for<br>osseous defects | | |
| Indications for<br>use | Indicated to fill bony voids or gaps<br>of the skeletal system (i.e.<br>extremities, and pelvis). These<br>defects may be surgically created<br>osseous defects or osseous<br>defects created from traumatic<br>injury to the bone. The device is<br>indicated only for bony voids or<br>gaps that are not intrinsic to the<br>stability of the bony structure. The<br>device provides a bone void filler<br>that resorbs and is replaced by<br>bone during the healing process. | Indicated to fill bony voids or gaps<br>of the skeletal system (i.e.<br>extremities, and pelvis). These<br>defects may be surgically created<br>osseous defects or osseous<br>defects created from traumatic<br>injury to the bone. The device is<br>indicated only for bony voids or<br>gaps that are not intrinsic to the<br>stability of the bony structure. The<br>device provides a bone void filler<br>that resorbs and is replaced by<br>bone during the healing process. | | |
| Target Population | Individuals with bony defects<br>resulting from surgery, trauma or<br>degeneration | Individuals with bony defects<br>resulting from surgery, trauma or<br>degeneration | | |
| Design | Self setting calcium phosphate<br>bone void filler which hardens in<br>aqueous environment at 37°C | Self setting calcium phosphate<br>bone void filler which hardens in<br>aqueous environment at 37°C | | |
| Components | Package contains one pre-formed<br>putty paste | Package contains one pre-formed<br>putty paste | | |
| Product<br>Preparation | None | None | | |
| Materials Characteristics | | | | |
| Chemical<br>Composition | Calcium salt | Calcium salt | | |
| Starting<br>Reactants | A pre-formed putty/paste is made<br>by mixing Alpha tricalcium<br>phosphate, sodium phosphate<br>monohydrate anhydrous,<br>carboxymethyl cellulose with<br>bioinert polyethylene glycol based<br>polymer. | A pre-formed putty/paste is made<br>by mixing Alpha tricalcium<br>phosphate, sodium phosphate<br>monohydrate anhydrous,<br>carboxymethyl cellulose with<br>bioinert polyethylene glycol based<br>polymer. | | |
| Crystal structure,<br>after hardening | Hydroxyapatite | Hydroxyapatite | | |
| Calcium to<br>phosphate ratio | 1.33 - 1.5 | 1.33 - 1.5 | | |
| Physical properties | | | | |
| Porosity | ~41.1% | ~41.1% | | |
| Density | 1.79 gm/cc | 1.79 gm/cc | | |
| Performance Characteristics | | | | |
| Working time | Approximately 15 minutes | Approximately 15 minutes | | |
| Setting Time | ~1.5 hours | ~1.5 hours | | |
| Total Curing Time | 24 hours | 24 hours | | |
| pH | Physiologic | Physiologic | | |
| Setting reaction<br>temperature | Isothermic | Isothermic | | |
| Solubility and<br>Dissolution | Similar to hydroxyapatite | Similar to hydroxyapatite | | |
| Pore size | 0.04 microns | 0.04 microns | | |
| Bone Remodeling | New bone grows into the graft area<br>via osteoconduction. The material<br>is replaced by cell mediated<br>remodeling tissue response | New bone grows into the graft area<br>via osteoconduction. The material<br>is replaced by cell mediated<br>remodeling tissue response | | |
| Osteoconductivity | Osteoconductive | Osteoconductive | | |
| Sterility | Sterilized by e-beam, single use<br>only | Sterilized by e-beam, single use<br>only | | |
| Endotoxin | 12 months | 12 months | | |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | | |
| Biocompatibility | Biocompatible | Biocompatible | | |
| Dosage /Size | 5, 10 сс | 5, 10 сс | | |

{7}------------------------------------------------