Straumann cerabone

K173594 · Institut Straumann AG · NPM · Oct 19, 2018 · Dental

Device Facts

• Record ID: K173594
• Device Name: Straumann cerabone
• Applicant: Institut Straumann AG
• Product Code: NPM · Dental
• Decision Date: Oct 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® cerabone® is used in the following intra-oral surgical procedures: - Alveolar ridge augmentation/ reconstruction - Filling of defects after root resection and apicoectomy - Filling alveoli after tooth extraction - Sinus elevation

Device Story

Straumann® cerabone® is a xenogeneic hydroxyapatite bone grafting material derived from bovine cancellous bone. The manufacturing process involves high-temperature sintering (up to 1250°C) to eliminate organic components, reducing rejection risks. The resulting material is a porous scaffold (>95% pentacalcium-hydroxy-tri-phosphate) with interconnected macro- and micro-pores (100–1,500 µm) that mimic human bone structure. Used by dental clinicians in intra-oral surgical procedures, the granules are implanted into a vital bone bed. The material acts as an osteoconductive scaffold, facilitating cell adhesion and stabilizing new bone matrix deposition. Over 6–8 months, the graft integrates into newly formed bone. It is provided in various particle sizes and volumes, packaged in a triple sterile barrier system, and terminally sterilized via gamma irradiation.

Clinical Evidence

Evidence includes bench testing, animal studies, and clinical literature review. Bench testing confirmed physicochemical properties per ASTM F1185-03 and F1581-99, and viral inactivation per ISO 22442-3. Biocompatibility was validated per ISO 10993 series (cytotoxicity, sensitization, irritation, subchronic toxicity, genotoxicity, implantation). An animal kinetic study in minipigs demonstrated osteoconductive capacity equivalent to the predicate. Clinical literature review supports the safety and efficacy for the proposed indications.

Technological Characteristics

Material: Xenogenic hydroxyapatite (≥95% Ca5(PO4)3(OH)) derived from bovine cancellous bone. Structure: Interconnected macro- (65–80 vol%) and micro-porous. Granule sizes: 0.5–1.0 mm and 1.0–2.0 mm. Sterilization: Gamma irradiation. Packaging: Triple sterile barrier (glass vial and two blisters). Standards: ASTM F1185-03, ASTM F1581-99, ISO 10993, ISO 11137-1, ISO 22442-3.

Indications for Use

Indicated for patients requiring intra-oral surgical procedures including alveolar ridge augmentation/reconstruction, filling of defects after root resection and apicoectomy, filling of alveoli after tooth extraction, and sinus elevation.

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

• Geistlich Bio-Oss (K122894)

Submission Summary (Full Text)

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October 19, 2018

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K173594

Trade/Device Name: Straumann® cerabone® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: September 17, 2018 Received: September 20, 2018

Dear Jennifer Jackson:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K173594

Device Name Straumann® cerabone®

Indications for Use (Describe)

Straumann® cerabone® is used in the following intra-oral surgical procedures:

- · Alveolar ridge augmentation/ reconstruction
- · Filling of defects after root resection and apicoectomy
- · Filling alveoli after tooth extraction
- Sinus elevation

| Type of Use (Select one or both, as applicable) | <table><tr><td><div> <input checked="checked" type="checkbox"/> Research Use (Part 21 CFR 201.3 Subpart D) </div></td></tr><tr><td><div> <input type="checkbox"/> Testing Conducted (21 CFR 201.3 Subpart G) </div></td></tr></table> | <div> <input checked="checked" type="checkbox"/> Research Use (Part 21 CFR 201.3 Subpart D) </div> | <div> <input type="checkbox"/> Testing Conducted (21 CFR 201.3 Subpart G) </div> |
|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <div> <input checked="checked" type="checkbox"/> Research Use (Part 21 CFR 201.3 Subpart D) </div> | | | |
| <div> <input type="checkbox"/> Testing Conducted (21 CFR 201.3 Subpart G) </div> | | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

| Submitter: | Straumann USA, LLC<br>(on behalf of Institut Straumann AG) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 60 Minuteman Road<br>Andover, MA 01810 |
| | Registration No.: 1222315<br>Owner/Operator No.: 9005052 |
| Contact Person: | Jennifer M. Jackson, MS<br>Director, Regulatory Affairs<br>[phone] |
| Prepared By &<br>Secondary Contact: | Christelle Gerspach-Gasser<br>Regulatory Affairs and Compliance Manager<br>Institut Straumann AG<br>[phone] |
| Date Prepared: | October 19, 2018 |
| Product Code(s): | NPM 21 CFR 872.3930 |
| Device Class: | II 21 CFR 872.3930 |
| Classification Panel: | Dental Devices |
| Classification Name: | Bone Grafting Material |
| Common Name: | Bone Grafting Material |
| Proprietary Name: | Straumann® cerabone® |
| Predicate Device(s): | K122894 Geistlich Bio-Oss |
| Device Description: | Straumann® cerabone® is a xenogeneic hydroxyapatite<br>ceramic for implantation into a vital bone bed during<br>intra-oral surgical procedures. It is manufactured from<br>bovine cancellous bone in a high temperature sintering<br>process lasting several hours at temperatures of up to<br>1250°C. This high temperature process results in all<br>organic components being eliminated so that the risk of<br>occurrence of allergic side effects or the occurrence of<br>rejection reactions is reduced.<br>Straumann® cerabone® is made of over 95% of<br>Pentacalcium-hydroxy-[tri]-phosphate Ca5(PO4)3(OH) |

on

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Due to the animal-derived starting material, Straumann® cerabone® possesses an interconnected macro- and micro-porous structure that strongly resembles human bone structure. The macroporosity lies within a range of 65–80 vol % and the pore size lies within a range of approximately 100 - 1,500 um. After implantation, the particles serve as an osteoconductive guide rail for new bone formation. The grafting material has high stability over several years with only minor signs of graft resorption.

Straumann® cerabone® acts as a scaffold for stabilization and the deposition of new bone matrix. Due to porosity and rough surface structure, Straumann® cerabone® facilitates cell adhesion. Subsequently, bone formation starts by deposition of primarily not yet mineralized bone matrix. Within a time period of six to eight months following implantation, the graft is integrated into the newly formed bone matrix.

Straumann® cerabone® is biocompatible and packed in a triple sterile barrier system consisting of a glass vial and two outer blisters and subject to sterilization by qammairradiation.

Straumann® cerabone® is offered in two particle size ranges (0.5 – 1.0 mm and 1.0 – 2.0 mm) and various pack sizes (0.5, 1.0, 2.0 and 5.0 cc).

| Art. No. | Article Name |
|----------|------------------------------------------------|
| BS-1510 | Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 0.5 cc |
| BS-1511 | Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 1.0 cc |
| BS-1512 | Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 2.0 cc |
| BS-1515 | Straumann® cerabone®, 0.5 - 1.0 mm, 1 x 5.0 cc |
| BS-1520 | Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 0.5 cc |
| BS-1521 | Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 1.0 cc |
| BS-1522 | Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 2.0 cc |
| BS-1525 | Straumann® cerabone®, 1.0 - 2.0 mm, 1 x 5.0 cc |

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Straumann® cerabone® is used in the following intra-oral Indications For Use: surgical procedures:

- Alveolar ridge augmentation/ reconstruction ●
- Filling of defects after root resection and ● apicoectomy
- Filling alveoli after tooth extraction .
- Sinus elevation .

Technological The subject and the predicate device are both sterile, Characteristics: biocompatible porous bone mineral materials for use in the same intra-oral surgical procedures.

> The subject and predicate devices are based on the following same technological elements:

- Pure cancellous bovine bone mineral (free from . organic compounds)
- . Rough surface structure, interconnecting macroand micro pores
- . Scaffold provision as mode of action
- . Same sterilization method and shelf life

The comparison between the features of the subject device and the predicate are provided in the table below. The Indications for Use for the subject device are a subset of the Primary Predicate Indications for Use.

| Feature | Subject Device<br>Straumann® cerabone® | Primary Predicate Devices<br>Geistlich Bio-Oss<br>K122894 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | Straumann® cerabone® is used in the following intra-oral surgical procedures:<br>Alveolar ridge augmentation/reconstruction Filling of defects after root resection and apicoectomy Filling alveoli after tooth extraction Sinus elevation | Geistlich Bio-Oss® is indicated for:<br>Augmentation or reconstructive treatment of the alveolar ridge Filling of intrabony periodontal defects Filling of defects after root resection, apicoectomy and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of the maxillary sinus floor Filling of periodontal defects in conjunction with products identified for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) |

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| Feature | Subject Device<br>Straumann® cerabone® | Primary Predicate Devices<br>Geistlich Bio-Oss<br>K122894 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | xenogenic hydroxyapatite (calcium<br>phosphate) ceramic manufactured<br>from cancellous (spongiosa)<br>bovine bone | xenogenic hydroxyapatite (calcium<br>phosphate) ceramic manufactured<br>from cancellous (spongiosa)<br>bovine bone |
| Origin | Femoral heads of cattle | Femoral heads of cattle |
| Form | Granules | Granules |
| Composition | - Hydroxyapatite (Pentacalcium-<br>hydroxy-[tri]-phosphate<br>Ca5(PO4)3(OH)) (≥95%)<br>- ≤2.5% other calcium phosphates<br>(traces of calcium carbonate<br>(CaO3) (<0.1%))<br>- No water (0%)<br>- No organic components (0%) | - Hydroxyapatite (Pentacalcium-<br>hydroxy-[tri]-phosphate<br>Ca5(PO4)3(OH)) (93.6%),<br>- Calcium carbonate (CaO3)<br>(3,4%)<br>- Water (3%)<br>- No organic components (0%) |
| Appearance<br>(dry state) | Whitish up to beige | Whitish |
| Structure /<br>Density | Matrix possessing an<br>interconnected macro- and micro-<br>porous structure. | Matrix consisting of interconnected<br>macro- and micropores, highly<br>porous with a large inner surface<br>area. |
| Specifications<br>/ Granules<br>sizes | Granule sizes<br>0.5 – 1.0 mm<br>1.0 – 2.0 mm | Granule sizes<br>0.25 – 1.0 mm<br>1.0 – 2.0 mm |
| Packaging &<br>Sterilization | Single use, triple sterile barrier<br>system, terminally gamma<br>sterilized by gamma irradiation | Single use, double sterile barrier<br>system, terminally gamma<br>sterilized by gamma irradiation |
| Sterilization | Gamma-irradiation | Gamma-irradiation |
| Shelf life | 3 years | 3 years |

Performance Data:

The following performance data were provided in support of the substantial equivalence determination

Sterilization and Shelf Life:

- Validation of sterilization process per ISO 11137-1 ●
- . Validation of shelf life per ASTM F1980

Biocompatibility Testing:

- Biocompatibility testing per ISO 10993-1 and the . following:
- Cytotoxicity per ISO 10993-5 o
- Sensitization per ISO 10993-10 o
- Irritation per ISO 10093-10 O
- Subchronic Toxicity per ISO 10993-11 o
- O Genotoxicity per ISO 10993-3
- Implantation per ISO 10993-6 o

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Performance Testing - Bench:

- Physicochemical and material characterization per ● ASTM F 1185-03 and ASTM F 1581-99
- . Viral inactivation demonstrated through validation of manufacturing steps, and the assessment of the potential pathogenic burden, quality management system in place. The Zoonosis assessment demonstrated that the validated manufacturing processes are sufficient to ensure a reduction of viral burden in accordance with the recommendation of the FDA recognized standard ISO 22442-3 and are sufficient for the demonstration of substantial equivalence to the predicate device.

Performance Testing - Animal:

- The osteoconductive capacity of Straumann® . cerabone® in intra-oral defects was assessed in a kinetic study in minipigs with comparison to the primary predicate Bio-Oss®. The performance of cerabone was equivalent to the primary predicate device Bio-Oss.
Performance Testing – Clinical:

- A review of the clinical literature was performed. . The reviewed literature supports the use of Straumann® cerabone® in the proposed Indications for Use.
- Conclusions: Following assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate device.