(300 days)
The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
OssBuilder System is consisted of metal devices, OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw, and is intended for use to stabilize and support of bone graft in dento-alveolar bony defect sites.
Tenting Screw, a product in the OssBuilder System product group, is a temporary dental implant that can be implanted in the bone defect site of the alveolar bone to fix the guided tissue regeneration material.
Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration.
This document describes the premarket notification (510(k)) for the OssBuilder System, an intraosseous fixation device. It asserts substantial equivalence to predicate devices based on non-clinical performance testing. Due to the nature of this submission, which focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical study, many of the typical elements expected for evaluating AI/algorithm performance (e.g., ground truth establishment with experts, MRMC studies, training/test set details) are not applicable or provided.
Here's a breakdown of the available information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, the "acceptance criteria" are not reported as specific performance metrics like accuracy, sensitivity, or specificity, which would be common for diagnostic AI/software. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through:
- Identical or similar design, operating principle, and intended use as predicates.
- Identical or similar materials.
- Successful non-clinical performance testing (bench tests) demonstrating comparable mechanical properties.
- Validated sterilization and shelf-life.
- Biocompatibility evaluation.
The reported device performance heavily relies on comparisons to predicate devices in the following aspects:
| Acceptance Criterion (Implicitly for SE) | Device Performance (Reported) |
|---|---|
| Intended Use | OssBuilder System: "used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site." This is compared to the predicate's intended use for fixing and stabilizing non-resorbable barrier membranes for tissue regeneration. The submission argues equivalence despite linguistic differences, viewing them as a whole system. |
| Principle of Operation | OssBuilder System (Tenting Screw): "is placed in maxilla or mandible bone area to be combined with OssBuilder (non-resorbable titanium membrane) and Healing Cap or Cover Cap. It helps to support and prevent the mobility of the membrane during the bone regeneration." This is compared to the predicate's "temporary dental implant ... to be combined with titanium membrane and cover screw or cover cap. It helps to support the membrane." Again, linguistic differences are noted but equivalence asserted. |
| Material | OssBuilder System: Ti-6Al-4V ELI (ASTM F136). Predicate (Neo GBR): Ti-6Al-4V ELI (ASTM F136). (Identical) |
| Dimensions (Tenting Screw) | OssBuilder System: Head Diameter: 3.0mm; Major Thread Diameter: 2.1mm; Length: 8.5, 10.0, 11.5, 13.0mm. Predicate (Neo GBR): Head Diameter: 2.85mm; Major Thread Diameter: 2.0mm; Length: 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2mm. (Similar, differences noted but deemed acceptable). |
| Dimensions (Healing Cap) | OssBuilder System: Diameter: 4.0, 5.0mm; Height: 7.0, 8.0mm. Predicate (K172354): Diameter: 4.0, 5.0mm; Height: 7.0, 8.0mm, 4.3mm (for Cover Cap). (Identical for healing cap). |
| Sterilization | OssBuilder System: Gamma Sterilization. Predicate: Gamma Sterilization. (Identical) |
| Shelf Life | OssBuilder System: 8 years. Predicate (Neo GBR): Unknown. Predicate (K172354): 8 years. (Similar/Identical to one predicate) |
| Biocompatibility | Evaluation conducted per ISO 10993-1. Deemed necessary as the OssBuilder System is made of same material, chemical composition, manufacturing process, and body contact with the predicate devices. (No additional testing required due to substantial equivalence in these factors). |
| Sterilization Validation & Shelf-life | Considered by leveraging data from prior submissions. |
| Mechanical Properties | Bench tests conducted per ASTM F543 (fracture load, insertion torque, axial pullout strength, torsional strength, breakage angle, removal torque, self-tapping force). Results found substantially equivalent to the predicate device for worst-case insertion in block material representing hard/soft bone. |
2. Sample Size for the Test Set and Data Provenance
This submission does not involve an AI/algorithmic device that would typically have a "test set" of patient data for performance evaluation. The "tests" performed are bench tests on the physical device components.
- Sample Size: Not explicitly stated as a number of devices/units tested, but refers to "Bench tests evaluated for OssBuilder System according to ASTM F543" for "worst-case insertion in block material." The assumption is that standard engineering testing practices for mechanical properties were followed.
- Data Provenance: The tests are laboratory-based bench tests, not patient data from a specific country. They are likely conducted at the manufacturer's facility or a contracted testing lab. The submission is made by a company based in the Republic of Korea (Osstem Implant Co., Ltd.) with a US correspondent (Hiossen Inc.).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. As this is a physical medical device submission demonstrating substantial equivalence through non-clinical testing, there is no "ground truth" derived from human experts interpreting medical images or data. The "ground truth" for mechanical properties is established by the specifications defined in standards like ASTM F543 and the performance of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Mechanical properties are measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device, and therefore, no MRMC comparative effectiveness study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the performance specifications and characteristics of the legally marketed predicate devices and generally accepted industry standards (e.g., ASTM F543) for mechanical properties testing, along with established biocompatibility guidelines (ISO 10993-1). The manufacturer demonstrates that the new device meets or is "substantially equivalent" to these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
May 7, 2019
Osstem Implant Co., Ltd. % Peter Lee OA/RA Manger Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K181854
Trade/Device Name: OssBuilder System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: Class II Product Code: DZL, NHA Dated: April 4, 2019 Received: April 5, 2019
Dear Peter Lee:
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.htm); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina Eydelman, M.D. Director 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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Image /page/2/Picture/1 description: This image contains the logo for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black text, with the word "OSSTEM" appearing in orange on the left side. Below the logo is the company's address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, along with their phone number: +82 51 850 2500, fax number: +82 51 861 4693, and website: www.osstem.com.
510(k) Number: K 181854
Device Name: OssBuilder System
Indication for Use:
The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
X | Prescription Use (21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
STEM Implant Co., L
510(K) Summary K181854
Date: May 07, 2019
1. Company and Correspondent making the submission
| Submitter's Name | OSSTEM IMPLANT Co., Ltd. |
|---|---|
| Address | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan612-070, Republic of Korea |
| Contact | Ms. Jungmin Yoo |
| Phone | +82-51-850-2500 |
| Correspondent's Name | HIOSSEN Inc. |
| Address | 85 Ben Fairless Dr.Fairless Hills, PA, 19030 |
| Contact | PETER LEE |
| Phone | 267-759-7031 |
-
- Device
| - Trade or (Proprietary) Name | : OssBuilder System |
|---|---|
| - Classification Name | : Intraosseous Fixation Screw or Wire |
| - Regulation Number | : 21CFR872.4880 |
| - Devce Classification | : Class II |
| - Classification Product Code | : DZL |
| - Subsequent Product Code | : NHA |
3. Predicate Device
- Primary Predicate -Neo GBR System, Neobiotech Co., Ltd. (K160991)
- -Reference Predicate OssBuilder System, OSSTEM Implant Co., Ltd. (K172354)
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-
- Description
OssBuilder System is consisted of metal devices, OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw, and is intended for use to stabilize and support of bone graft in dento-alveolar bony defect sites.
- Description
Tenting Screw, a product in the OssBuilder System product group, is a temporary dental implant that can be implanted in the bone defect site of the alveolar bone to fix the guided tissue regeneration material.
Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration.
| Item | Content | ||
|---|---|---|---|
| Tenting Screw | Description | Tenting Screw is used for space maintenance of the bone graft material for horizontal and vertical bone augmentation in the alveolar bone defect site. | |
| Material | Ti-6Al-4V (ASTM F 136) | ||
| Dimension (mm) | D (Ø, implanted) | 2.1 | |
| Total Length | 8.5, 10.0, 11.5, 13.0 | ||
| Healing Cap | Description | Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration. | |
| Material | Ti-6Al-4V (ASTM F 136) | ||
| Dimension (mm) | D (Ø) | 4, 5 | |
| Total Length | 7, 8 |
The OssBuilder System is compatible with OssBuilder, Healing Cap, and Cover Cap of OssBuilder System cleared in K172354.
-
- Substantial Equivalence Matrixes
| OssBuilder System | Neo GBR System | Remark | |
|---|---|---|---|
| 510(K) | Proposed | Predicated (K160991) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Neobiotech. Co., Ltd. | Different |
| Device Name | Tenting Screw | Tent Screw | Different |
| Design | Image: Tenting Screw | Image: Tent Screw | Similar |
| Indication forUse | The OssBuilder System is usedfor space maintenance andstabilization of bone graftingmaterial in an alveolar bonedefect site. | Neo GBR System is intendedto fixate and stabilize non-resorbable barrier membranesused for regeneration of tissuein the oral cavity or in dentalsituations that requiremembrane use or fixation. | The propose deviceand the predicateddevice has differentindication for use inlanguage. Theindication for usefor the proposeddevice is forindividual device(Tenting Screw)within the system,while the indicationfor use for thepredicated device isfor the overalldevices in the NeoGBR System.Therefore, it can besaid that theindication for usefor both devices areequivalent whenviewed as a wholesystem. |
| Principle ofOperation | Tenting Screw is placed inmaxilla or mandible bone areato be combined withOssBuilder (non-resorbabletitanium membrane) andHealing Cap or Cover Cap. Ithelps to support and preventthe mobility of the membraneduring the bone regeneration.Since it is used for temporaryuse, second surgery is requiredto remove them after boneregeneration. | The function of Bone screwbody is temporary dentalimplant (Screw) that place inmaxilla or mandible bone areato be combined with titaniummembrane and cover screw orcover cap. It helps to supportthe membrane. Second surgeryfor removal is required. | The proposeddevice and thepredicated devicehas differentprinciple ofoperation inlanguage, howeverthe difference inlanguage does notchange the intendeduse or substantialequivalence status. |
| Material | Ti-6A1-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Identical |
| HeadDiameter(mm) | 3.0 | 2.85 | Similar |
| MajorThreadDiameter(mm) | 2.1 | 2.0 | Similar |
| Length (mm) | 8.5, 10.0, 11.5, 13.0 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2,18.2 | Within the range ofthe predicated. |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Identical |
| Shelf Life | 8 years | Unknown | Similar |
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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a stylized design. Below it, the word "IMPLANT" is written in gray, smaller font. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea
Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
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Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
S.E. Similarities The proposed Tenting Screw has similar shape, is made of same material and has same sterilization method compared to the predicated Tent Screw of Neo GBR System (K160991). Differences The implanted diameter and the length of the proposed device and the predicated device are different. : . While its dimension is different from the predicated, the proposed Tenting Screw is made of same material and has same function and intended use; therefore, the proposed Tenting Screw is substantially equivalent to the predicated Tent Screw of Neo GBR System (K160991).
| OssBuilder System | OssBuilder System | Remark | |
|---|---|---|---|
| 510(k) No. | Proposed | Predicated (K172354) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Device Name | Healing Cap | Healing Cap Cover Cap | Identical |
| Design | Image: Healing Cap | Image: Healing Cap and Cover Cap | Identical |
| Intended Use | OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. | OssBuilder System is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. | Identical |
| Principle of Operation | Where Tenting Screw is placed in maxilla or mandible bone area, it is combined with OssBuilder (non-resorbable titanium membrane) and Healing Cap or Cover Cap. Healing Cap is intended by connecting with Tenting Screw to fix OssBuilder during osseointegration. Second surgery is required to remove them after bone regeneration. | Healing Cap and Cover Cap is used by Connecting with the OB Anchor to fix OssBuilder during osseointegration. Second surgery is required to remove them after bone regeneration. | Healing Cap can be connected with Tenting Screw or OB Anchor to fix OssBuilder during osseointegration. |
| Material | Ti-6Al-4V(ASTM F136) | Pure Titanium Grade 4(ASTM F67)Ti-6Al-4V(ASTM F136) | Identical |
| Diameter (mm) | 4.0, 5.0 | 4.0, 5.04.0 | Identical |
| Height (mm) | 7.0, 8.0 | 7.0, 8.04.3 | Identical |
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Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in large, bold, orange letters. Below it, the word "IMPLANT" is in smaller, gray letters. There is a small orange circle with a white number 6 in the upper right corner of the logo.
CM Imr nt Co.. I t
undae-gu Busan Republic of Korea 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| Sterilization | Gamma Sterilization | Gamma Sterilization | Identical |
|---|---|---|---|
| Shelf Life | 8 years | 8 years | Identical |
| S.E. | SimilaritiesThe proposed Healing Cap has same dimension, function and indication for use; and istreated with same sterilization method and made by same manufacturer compared to thepredicated Healing Cap (K172354).DifferencesThe proposed Healing Cap is made of Ti-6Al-4V (ASTM F136) while the predicatedHealing Cap is made to Ti Grade 4 (ASTM F67), but has made with same materialcompared to the predicated Cover Cap.∴ The propose Healing Cap has different only in raw material compared to thepredicated Healing Cap (K172354), but it has made with same material compared to thepredicated Cover Cap (K172354). Except for this change/difference, its function,dimension, indication for use, etc. is same compared to the predicated; therefore, theproposed Healing Cap is substantially equivalent to the predicated Healing Cap(K172354). |
-
- Indication for Use
The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
- Indication for Use
-
- Summary of Non-Clinical Performance Testing
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
- Summary of Non-Clinical Performance Testing
Biocompatibility evaluation
Biocompatibility evaluation was conducted per the FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." No additional biocompatibility testing for OssBuilder System was deemed necessary as the OssBuilder System is made of same material, chemical composition, manufacturing process and body contact with the predicated devices, Neo GBR System, K160991; and OssBuilder System, K172354.
Sterilization Validation and Shelf-life
All subject devices in OssBuilder System are delivered in sterile. Therefore, the shelf-life and sterilization validation was considered. We considered them by leveraging the data that of our prior submissions.
Mechanical Properties
Bench tests evaluated for OssBuilder System according to ASTM F543. Comparative mechanical testing was conducted to evaluate the mechanical properties including fracture load, insertion torque, axial pullout strength, torsional strength, breakage angle, removal torque, and self-tapping force following per ASTM F543 for worstcase insertion in block material that represents hard/soft bone. Mechanical properties
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Image /page/8/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray.
OSSTEM Implant Co., Lt
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
from bench tests of OssBuilder System found substantially equivalent to the predicate device.
-
- Summary of Clinical Testing
No clinical studies are submitted.
- Summary of Clinical Testing
-
- Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, OSSTEM IMPLANT Co., Ltd. concludes that the OssBuilder System is substantially equivalent to the predicated devices as herein.
- Conclusion
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.