(300 days)
No
The summary describes a system of metal devices for bone grafting support and stabilization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on biocompatibility, sterilization, shelf-life, and mechanical properties, which are typical for physical implants and do not suggest AI/ML involvement.
Yes
The device is described for space maintenance and stabilization of bone grafting material in an alveolar bone defect site, which is a therapeutic intervention. It is intended to stabilize and support bone graft, and fix guided tissue regeneration material. These actions directly treat a condition (bony defect) rather than just diagnose or provide information.
No
The device is used for stabilizing bone grafting material and maintaining space in bone defects, not for diagnosing medical conditions.
No
The device description explicitly states that the OssBuilder System is "consisted of metal devices" and lists specific hardware components like "OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw." The performance studies also focus on biocompatibility, sterilization, shelf-life, and mechanical properties of these physical components, not software.
Based on the provided information, the OssBuilder System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "space maintenance and stabilization of bone grafting material in an alveolar bone defect site." This is a surgical/implantable function, not a diagnostic test performed on samples from the body.
- Device Description: The description details metal devices (screws, caps) used to stabilize bone graft material. This aligns with a surgical implant system.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, sterilization, and shelf-life, which are typical for implantable medical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The OssBuilder System's function is entirely focused on supporting bone grafting during a surgical procedure.
N/A
Intended Use / Indications for Use
The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
Product codes (comma separated list FDA assigned to the subject device)
DZL, NHA
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar bone defect site
maxilla or mandible bone area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
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.
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.
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 from bench tests of OssBuilder System found substantially equivalent to the predicate device.
No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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)
3
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, Busan |
| 612-070, 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)
4
-
- 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 for | |||
| Use | The OssBuilder System is used | ||
| for space maintenance and | |||
| stabilization of bone grafting | |||
| material in an alveolar bone | |||
| defect site. | Neo GBR System is intended | ||
| to fixate and stabilize non- | |||
| resorbable barrier membranes | |||
| used for regeneration of tissue | |||
| in the oral cavity or in dental | |||
| situations that require | |||
| membrane use or fixation. | The propose device | ||
| and the predicated | |||
| device has different | |||
| indication for use in | |||
| language. The | |||
| indication for use | |||
| for the proposed | |||
| device is for | |||
| individual device | |||
| (Tenting Screw) | |||
| within the system, | |||
| while the indication | |||
| for use for the | |||
| predicated device is | |||
| for the overall | |||
| devices in the Neo | |||
| GBR System. | |||
| Therefore, it can be | |||
| said that the | |||
| indication for use | |||
| for both devices are | |||
| equivalent when | |||
| viewed as a whole | |||
| system. | |||
| Principle of | |||
| Operation | 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. | |||
| Since it is used for temporary | |||
| use, second surgery is required | |||
| to remove them after bone | |||
| regeneration. | The function of Bone screw | ||
| body is temporary dental | |||
| implant (Screw) that place in | |||
| maxilla or mandible bone area | |||
| to be combined with titanium | |||
| membrane and cover screw or | |||
| cover cap. It helps to support | |||
| the membrane. Second surgery | |||
| for removal is required. | The proposed | ||
| device and the | |||
| predicated device | |||
| has different | |||
| principle of | |||
| operation in | |||
| language, however | |||
| the difference in | |||
| language does not | |||
| change the intended | |||
| use or substantial | |||
| equivalence status. | |||
| Material | Ti-6A1-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Identical |
| Head | |||
| Diameter | |||
| (mm) | 3.0 | 2.85 | Similar |
| Major | |||
| Thread | |||
| Diameter | |||
| (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 of | ||
| the 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
6
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, 5.0 | |
| 4.0 | Identical | ||
| Height (mm) | 7.0, 8.0 | 7.0, 8.0 | |
| 4.3 | Identical |
7
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. | Similarities | ||
| The proposed Healing Cap has same dimension, function and indication for use; and is | |||
| treated with same sterilization method and made by same manufacturer compared to the | |||
| predicated Healing Cap (K172354). |
Differences
The proposed Healing Cap is made of Ti-6Al-4V (ASTM F136) while the predicated
Healing Cap is made to Ti Grade 4 (ASTM F67), but has made with same material
compared to the predicated Cover Cap.
∴ The propose Healing Cap has different only in raw material compared to the
predicated Healing Cap (K172354), but it has made with same material compared to the
predicated Cover Cap (K172354). Except for this change/difference, its function,
dimension, indication for use, etc. is same compared to the predicated; therefore, the
proposed 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
8
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