CMFlexTM

K213260 · Dimension Inx Corp. · LYC · Dec 30, 2022 · Dental

Device Facts

• Record ID: K213260
• Device Name: CMFlexTM
• Applicant: Dimension Inx Corp.
• Product Code: LYC · Dental
• Decision Date: Dec 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include: - Intrabony periodontal osseous defects - Furcation defects - Bony defects or bony deficiencies of the alveolar ridge - Intraoral, maxillofacial, and mandibular augmentation - Bony defects of the upper or lower jaw - Filling of tooth extraction sites - Sinus elevation grafting

Device Story

CMFlex™ is a synthetic, osteoconductive bone grafting material provided as a sterile, single-use block. It is fabricated via extrusion-based 3D-printing of liquid inks, resulting in a porous structure composed of synthetic hydroxyapatite powder bound by a biodegradable polylactide-co-glycolide (PLG) polymer. Surgeons trim the blocks to fit specific patient bone defects in maxillofacial, mandibular, or intraoral sites. The device is not intended for immediate load-bearing; it functions by providing a scaffold that remodels over time, being replaced by new bone tissue. The device benefits patients by facilitating bone regeneration in osseous defects. It is used in clinical settings by surgeons who manually place the graft into the defect site.

Clinical Evidence

Non-clinical performance testing included chemical composition (TGA), crystallinity (XRD, ASTM F2024), morphology (SEM), porosity (BET), mechanical strength (ASTM D695), pH (ASTM F1635), and biocompatibility (ISO 10993). Preclinical performance was evaluated in a canine one-wall dental defect model at 4, 8, and 12 weeks using radiography, microCT, and histomorphometry. Results showed CMFlex™ maintained ridge dimensions and exhibited bone-forming capacity and inflammatory response comparable to the predicate device.

Technological Characteristics

Synthetic bone graft composed of 90% hydroxyapatite and 10% PLG. Fabricated via extrusion-based 3D-printing. Porosity >80%, pore size 0.20-0.27 mm. Sterile, single-use block form. Standards: ASTM F2024-10R21 (crystallinity), ASTM D695-15 (compressive strength), ASTM F1635-16 (pH), ISO 10993 (biocompatibility), ISO 11737-1 (bioburden), ISO 11138-1 (sterilization).

Indications for Use

Indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects, including periodontal defects, furcation defects, alveolar ridge deficiencies, tooth extraction sites, and sinus elevation grafting.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• OsteoScaf™ (K101827)

Reference Devices

• Easy-Graft® (K131385)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Dimension Inx Corp. Ramille Shah Chief Science Officer 3440 S Dearborn St. Suite 142S Chicago, Illinois 60616

Re: K213260

Trade/Device Name: CMFlex™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: December 19, 2022 Received: December 19, 2022

Dear Ramille Shah:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K21360

Device Name CMFlex(TM)

#### Indications for Use (Describe)

CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include: 22552

- · Intrabony periodontal osseous defects
- · Furcation defects
- · Bony defects or bony deficiencies of the alveolar ridge
- · Intraoral, maxillofacial, and mandibular augmentation
- · Bony defects of the upper or lower jaw
- · Filling of tooth extraction sites
- · Sinus elevation grafting

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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K213260 CMFlex™

#### 510(K) Summary

DEVICE TRADE NAME CMFlex™

#### MANUFACTURER

Dimension Inx 3440 S. Dearborn St., Suite 142S Chicago, IL 60616 Phone: [phone]

## CONTACT

Ramille Shah, Ph.D. ramilleshah(@dimensioninx.com

#### Consultant:

Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA Associate Director, Regulatory Affairs, MCRA, LLC Office: [phone] mkazemzadeh(@mcra.com

#### DATE PREPARED

December 30, 2022

#### CLASSIFICATION

Bone Grafting Material, Synthetic (21 CFR 872.3930)

## PRODUCT CODE LYC

#### PRIMARY PREDICATE

Trade name: OsteoScaf™ Common name: Bone Grafting Material, Synthetic 510(k) number: K101827

#### REFERENCE DEVICE

Trade name: Easy-Graft® Common name: Bone Grafting Material, Synthetic 510(k) number: K131385

#### INDICATIONS FOR USE

CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include:

- -Intrabony periodontal osseous defects
- Furcation defects
- Bony defects or bony deficiencies of the alveolar ridge -
- -Intraoral, maxillofacial, and mandibular augmentation
- Bony defects of the upper or lower jaw -
- -Filling of tooth extraction sites
- -Sinus elevation grafting

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## DEVICE DESCRIPTION

CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.

# CMFLEXTM BLOCK SIZES AND VOLUMES

| Product | Dimensions (mm) | Approximate<br>Volume |
|---------------------|-------------------|-----------------------|
| CMFlex™ Block, 1cc | <br>15<br>15<br>5 | 1 cc |
| CMFlex™ Block, 6cc | <br>38<br>38<br>4 | 6 cc |
| CMFlex™ Block, 13cc | <br>38<br>38<br>9 | 13 cc |

Table 1.1. CMFlex™ Block Sizes and Volumes

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

| | Table 1.2. CMFlex™ as Compared to Predicate and Reference Devices |
|--|-------------------------------------------------------------------|
|--|-------------------------------------------------------------------|

| | Subject Device | Primary Predicate<br>Device | Secondary Predicate<br>Device | Comparison |
|--------------------------|---------------------|-------------------------------------------------------|-------------------------------|----------------------------|
| Trade Name | CMFlex™ | OsteoScaf™ | Easy-Graft® | N/A |
| Manufacturer | Dimension Inx Corp. | Texas Innovative<br>Medical Devices<br>(DBA) Skeletal | Guidor® | N/A |
| 510(k) Number | K213260 | K101827 | K131385 | N/A |
| Product Code | | LYC | | Same product code |
| Device Class | | Class II | | Same device class |
| Device<br>Classification | | Bone grafting material, synthetic | | Same device classification |

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# Dimension Inx

| Indications for Use | Indicated for filling<br>and/or augmenting<br>maxillofacial,<br>mandibular, and<br>intraoral osseous<br>defects. Indications<br>may include:<br>- Intrabony<br>periodontal osseous<br>defects<br>- Furcation defects<br>- Bony defects or bony<br>deficiencies of the<br>alveolar ridge<br>- Intraoral,<br>maxillofacial, and<br>mandibular<br>augmentation<br>- Bony defects of the<br>upper or lower jaw<br>- Filling of tooth<br>extraction sites<br>- Sinus elevation<br>grafting | Indicated for filling<br>and/or augmenting<br>intraoral/maxillofacial<br>osseous defects, such<br>as intrabony<br>periodontal osseous<br>defects, furcation<br>defects, augmentation<br>of bony defects of the<br>alveolar ridge, filling<br>of tooth extraction<br>sites, and sinus<br>elevation grafting. | Indicated for the<br>treatment of intraoral /<br>maxillofacial osseous<br>defects. Dental and<br>maxillo-facial<br>indications may<br>include: extraction<br>defects (alveolar ridge<br>preservation),<br>periodontal defects,<br>pen-implant defects,<br>augmentation of<br>deficient alveolar crest,<br>sinus floor<br>augmentation, defects<br>after surgical<br>extractions, defects<br>after removal of bony<br>cysts, defects after root<br>resection or<br>apicoectomy, defects<br>after removal of<br>autologous bone. | Intended use includes<br>elements of the predicate<br>devices, supported by<br>performance testing in canines |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|

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| Prescription/OTC | Prescription | | | All require prescription |
|------------------------|-----------------------------------------|-----------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Composition | 90% HA<br>10% PLG | 78% CP<br>22% PLG | 99% β-TCP<br>1% PLG<br>N-methyl-2-<br>pyrrolidone | All devices comprised of a<br>majority calcium phosphate<br>component combined with a<br>degradable polymer<br>component |
| Physical<br>Morphology | Interconnecting pore structure | | | Similar pore morphology |
| Porosity (Nominal) | 85% | 80% | 53% | Similar porosity to primary<br>predicate |
| Pore Size | 0.20 - 0.27 mm | 0.20 mm | 0.23 mm | All devices have similar pore<br>sizes |
| Form | Block | Particulate, Cylinder,<br>Block | Granule | Similar form factor to primary<br>predicate |
| Crystallinity | 96% | Not Available | 92% | Similar crystallinity to<br>secondary predicate |
| Resorption1 | Resorbable | Resorbable | Resorbable | Similar resorption<br>characteristics to primary<br>predicate |
| Sterility | Sterile; One-time<br>single patient use | Sterile; One-time<br>single patient use | Sterile; One-time<br>single patient use | All devices are sterile and for<br>single use only |

1Based on composition

# Device Intended Use and Descriptions

CMFlex™, OsteoScaf™, and Easy-Graft® are all sterile, porous, ceramic-polymer composite single-use bone grafting materials intended for use in the filling, augmenting, or treating intraoral/maxillofacial defects. All three are class II devices and fall under the same product code, LYC.

# Device Compositions and Resorption

CMFlex™, OsteoScaf™ and Easy-Graft® are comprised of discrete micro-scale, spherical calcium phosphate ceramic particles (90. 78. 99 wt.%, respectively) and the biodegradable polyester binder, poly(lactide-co-glycolide), or PLG, (10, 22, 1 wt.%, respectively). The phase of the calcium phosphate component of CMFlex™ is primarily synthetic hydroxyapatite, with minor amounts of beta tricalcium phosphate (B-TCP), while the phases of the calcium phosphate components of OsteoScaf™ and Easy-Graft® are minority hydroxyapatite, with majority di/tetra calcium phosphate and ß-TCP, respectively. The calcium phosphate components of CMFlex™ and Easy-Graft® are primarily crystalline (>90%) and the particles comprising CMFlex™ are 23 um in diameter on average, while those of OsteoScaf™ are 27.5 um on average. The difference in composition among the devices primarily affect the rate of resorption of the devices, but do not affect the substantial equivalanceof the devices for their intended use.

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# Device Porositv

Like CMFlex™, OsteoScaf™, and Easy-Graft® possess interconnected micro-and macro-pores formed by overlapping fibers or bound calcium phosphate particles. While CMFlex™ and OsteoScaf™ have total porosity exceeding 80 vol. %, Easy-Graft® had a measured porosity of 53.4 vol.%; however, this value does not include the interconnected porosity within the larger calcium phosphate particles that comprise the majority of Easy-Graft® (which could not be accurately measured). Thus, the actual total porosity of Easy-Graft® may be significantly greater than 53.4 vol.%. and more similar to CMFlex™ and OsteoScaf™ (both >80% porosity with 0.25-1.20 mm pore size). Like CMFlex™, OsteoScaf™ and Easy-Graft® are flexible or moldable, absorb fluid, and are bioresorbable.

# Device Form Factors and Volumes

CMFlex™ and OsteoScaf™ are comparable in form factors and sizing: CMFlex™ is available in blocks of varying volumes, while OsteoScaf™ is available in blocks, cylinders, and particulates. Like the various OsteoScaf™ form factors, the various CMFlex™ block volume options are provided as a convenience to the surgeon. Both CMFlex™ and OsteoScaf™ may be further trimmed to ensure an appropriate, custom fit to the patient's defect. Easy-Graft® is available in multiple volumes, but rather than solid form factors, it comes as a kit of PLG coated calcium phosphate particles that are mixed with solvent prior to injection into boney defect. All CMFlex™ volumes share a single "indications for use" statement, which is common to the "indications for use" statement provided for the OsteoScaf™ and Easy-Graft® predicate devices.

# PERFORMANCE DATA

The following non-clinical and preclinical tests were performed to support a demonstration of substantial equivalence:

| Purpose | Method | Conclusions<br>(based on testing results and published information) |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemical composition | Thermogravimetric analysis | The subject and predicate devices are composed of a majority calcium phosphate component and minority biodegradable polyester component. |
| Crystallinity (of calcium phosphate component) | X-ray diffraction, ASTM F2024-10R21 | The subject and predicate devices have calcium phosphate crystallinities >90%. |
| Calcium phosphate particle morphology | Scanning electron microscopy | The subject and predicate devices possess spherical calcium phosphate particles. |
| Pore structure | Scanning electron microscopy | The subject and predicate devices have interconnected pores around 0.2mm and primary pores around 1mm. |
| Porosity | Porosimetry (BET analysis) | The subject and predicate devices have porosities greater than 50%. |
| Mechanical strength (compressive) | Compressive mechanical testing, ASTM D695-15 | The devices provide adequate handling properties and strength to ensure dimensional integrity when handled by the surgeon and delivered to bony application sites; devices have similar compressive properties. |
| pH in phosphate buffered saline | ASTM F1635-16 | The subject and predicate device have similar pH. |
| Biocompatibility | ISO 10993 series of standards | Devices passed cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity testing according to ISO 10993. |
| Performance in animal<br>model | Canine critical sized<br>defect model and ISO<br>10993-6 | CMFlexTM was evaluated for performance and<br>biocompatibility as compared to the predicate device in a<br>one-wall dental defect canine model at 4, 8, and 12 weeks.<br>Assessments included radiography, microCT, and<br>histomorphometric analysis. Endpoints included new bone<br>growth, residual implant material, preservation of ridge<br>(height, width, depth), changes to surrounding bone, and<br>any significant adverse findings (i.e., exuberant necrosis,<br>proliferative granulation tissue/fibrosis, extensive<br>inflammation, or evidence of infection). Results<br>demonstrated that CMFlexTM was able to maintain ridge<br>height, width, and depth and showed similar bone forming<br>capacity and steady state inflammatory response<br>accompanying the absorption<br>process when compared to the predicate device. |
| Sterilization Validation | Pre-Sterilization<br>Bioburden (ISO 11737-<br>1); LAL Endotoxin<br>(USP<85>); Chamber<br>Mapping; Residuals<br>testing; Bioburden<br>Recovery, Inactivation<br>Kinetics (ISO 11138-1);<br>Performance<br>Qualification (ISO<br>11138-1:2017, ISO<br>11138-7:2019, ISO<br>14937:2009) | CMFlexTM passed all acceptance criteria for validating the<br>end sterilization method. |
| Shelf Life | Device properties after<br>accelerated and real time<br>aging: Compressive<br>mechanical testing,<br>polymer molecular<br>weight, ceramic<br>composition and<br>crystallinity (ASTM<br>F2024:2021), and<br>microstructure (SEM) | CMFlexTM had no significant mechanical property changes<br>or clinically meaningful compositional (ceramic and<br>polymer component) and microstructural changes after<br>accelerated (12-month simulation) and real-time aging (6<br>months and 12 months). |
| Package Integrity Testing<br>(Initial and aged<br>samples) | ASTM F2096; ASTM<br>F88 | CMFlexTM packaging passed all package integrity testing<br>as is and after accelerated (12-month simulation) and real-<br>time aging (6 months and 12 months). |

Table 1.3 Substantial Equivalence Performance Testing Summary

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# CONCLUSIONS

CMFlex™ was compared with the identified predicate devices based on the indications for use, composition, porosity, mechanical strength, biocompatibility testing, and performance studies. CMF lex™ has similar compositional components (e.g., a combination of a biodegradable polymer and calcium phosphate particles), microstructural properties (percent porosity and pore size), pH, and compressive mechanical characteristics. Furthermore, CMFlex™ passed all biocompatibility testing per ISO 10993, and head-to-head comparison with the predicate in a canine critically sized dental defect model showed similar bone forming capacity associated with device remodeling and osteoconduction over time. Based on these studies, the subject device, CMFlex™ is found to be substantially equivalent to the predicate device.