(298 days)
No
The 510(k) summary describes a mechanical device (screws and tacks) for bone fixation and does not mention any AI or ML components or functionalities.
No
The device is described as a bone screw and bone tack used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes for bone regeneration or to stabilize fractured bone segments. Its function is mechanical stabilization and fixation, not therapeutic.
No
Explanation: The device is described as a Bone Screw and Bone Tack used to "stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone" and "stabilize and support bone graft and/or fractured bone segments." These are functions related to surgical fixation and structural support, not diagnosis. There is no mention of the device collecting, analyzing, or interpreting data for the purpose of identifying a disease or condition.
No
The device description clearly indicates that the device is a physical bone screw and bone tack, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used to stabilize and fixate bone grafts, bone filling material, and barrier membranes in the oral cavity. This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description details the physical characteristics and function of screws and tacks used for bone fixation and stabilization. This aligns with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, this device falls under the category of a surgical or implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.4 diameter screw is for fixing membrane or bone plate, and Ø2.0 diameter screw is for fixing block bone.
Material: Ti-6Al-4V (ASTM F 136)
Dimension (mm): D (Ø, implanted) 1.4, 1.95; Length 4.0, 6.0, 8.0, 10, 12, 14, 16
Bone Tack is a stabilizer that can stably fix the membrane in GBR.
Material: Ti-6Al-4V (ASTM F 136)
Dimension (mm): D (Ø, Head) 2.5; Length 3.0
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, oral and maxillofacial site defects, maxillary and/or mandibular areas
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: Biocompatibility testing was considered following 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"and the ISO 10993 suite of standards and leveraged from reference device K172354.
Sterilization Validation and Shelf-life: All subject devices are delivered sterile. Sterilization validation and shelf-life was considered following the ISO 11137 and ISO 11607 suites of standards. Endotoxin batch testing is in place per the FDA Guidance Document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Mechanical Properties: Mechanical testing was evaluated following ASTM F543 with the worst case scenario.
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.
K050669, K080074, K161604, K172354
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.
0
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 seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
August 9, 2019
Osstem Implant Co., Ltd. Jungmin Yoo RA Manager 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, 612-070 Kr
Re: K182881
Trade/Device Name: Bone Screw. Bone Tack Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: July 18, 2019 Received: July 18, 2019
Dear Jungmin Yoo:
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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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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Image /page/2/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850 2500, the fax number is +82 51 861 4693, and the website address is www.osstem.com.
510(k) Number: K182881
Device Name: Bone Screw, Bone Tack
Indication for Use:
Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.
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)
QS-QI-505-7(Rev.0)
3
DSSTEM 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
510(K) Summary
K182881
Date: August 9, 2019
1. Company and Correspondent making the submission
| - Submitter's Name
-
Address
-
Contact
-
Phone | : OSSTEM IMPLANT Co., Ltd.
: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 612-070, Republic of Korea
: Ms. Jungmin Yoo
: +82-51-850-2500 |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| - Correspondent's Name -
Address
-
Contact
-
Phone | : HIOSSEN Inc.
: 85 Ben Fairless Dr.
Fairless Hills, PA, 19030
: PETER LEE
: 267-759-7031 | -
- Device
| - Trade or (Proprietary) Name | : Bone Screw, Bone Tack |
|---|---|
| - Classification Name | : Screw, Fixation, Intraosseous |
| - Regulation Number | : 21CFR872.4880 |
| - Devce Classification | : Class II |
| - Classification Product Code | : DZL |
3. Predicate Device
- -Primary Predicate Fixation Screw of Straumann GBR System, INSTITUT STRAUMANN AG (K011698)
- Reference Devices -
Bone Screw of Jeil Bone Fixation System, Jeil Medical Corporation (K050669) truTACK of ACE Tru-FIX Implant System, ACE Surgical Supply Co., Inc. (K080074) Osstem Implant System, OSSTEM Implant Co., LTd. (K161604) OssBuilder System, OSSTEM Implant Co., Ltd. (K172354)
4
Image /page/4/Picture/0 description: This image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is +82 51 850 2500, and the fax number is +82 51 861 4693. The website address is www.osstem.com.
4. Description
Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Bone Tack is used to fix the membrane in GBR.
| Item | Content | ||
|---|---|---|---|
| Bone Screw | Description | Bone Screw is using as anchor to fix the bone plate, membrane that cover bone | |
| material or block bone for bone regeneration or remodeling. Ø1.4 diameter | |||
| screw is for fixing membrane or bone plate, and Ø2.0 diameter screw is for | |||
| fixing block bone. | |||
| Material | Ti-6Al-4V (ASTM F 136) | ||
| Dimension | |||
| (mm) | D (Ø, implanted) | 1.4, 1.95 | |
| Length | 4.0, 6.0, 8.0, 10, 12, 14, 16 | ||
| Bone Tack | Description | Bone Tack is a stabilizer that can stably fix the membrane in GBR. | |
| Material | Ti-6Al-4V (ASTM F 136) | ||
| Dimension | |||
| (mm) | D (Ø, Head) | 2.5 | |
| Length | 3.0 |
5. Substantial Equivalence Matrixes
| | Bone Screw | Straumann
GBR System | Jeil Bone
Fixation System | Remark |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Proposed | Primary Predicate
(K011698) | Reference Device
(K050669) | - |
| Manufacturer | Osstem Implant
Co., Ltd. | Straumann USA | Jeil Medical
Corporation | - |
| Design | Image: Bone Screw | Image: Straumann GBR System | Image: Jeil Bone Fixation System | Similarity |
| Indications
for Use
Statement | Bone Screw is used
to stabilize and fixate
bone grafts, bone
filling material,
and/or barrier
membranes used for
regeneration of bone
in the oral cavity. | The Straumann
Guided Bone
Regeneration (GBR)
System is used to
stabilize and fixate
bone grafts, bone
filling materials,
and/or barrier | The device is
intended for use in
stabilizing and
fixating bone grafts,
bone filling material
and/or barrier
membranes used for
guided bone/tissue | Similarity.
Small changes
are due to
differences in
component-
specific
language. |
| | membranes used for
regeneration of bone
in the oral cavity.
The GBR technique
can make it possible
for the placement of
dental implants in
previously unsuitable
sites. | regeneration in the
oral cavity. Single
patient use only. | | |
| Material | Titanium Alloy
(Ti-6Al-4V,
ASTM F136) | Titanium
(Ti Grade 4,
ASTM F67) | Titanium Alloy
(Ti-6Al-4V,
ASTM F136) | Identical as that
of the reference
device |
| Screw
Diameter | 1.4 mm
1.95 mm | 1.2 mm
1.5 mm | 1.4 mm
1.6 mm
2.0 mm | Different but the
range of screw
diameter and the
screw length is
within the
permissible |
| Screw Length | Ø1.4:
4.0 mm
6.0 mm
8.0 mm
Ø1.95:
8.0 mm
10.0 mm
12.0 mm
14.0 mm
16.0 mm | 3.0 mm
4.0 mm
5.0 mm
7.0 mm
8.0 mm
9.0 mm
10.0 mm
12.0 mm
14.0 mm | 4.0 mm
5.0 mm
6.0 mm
8.0 mm
10.0 mm
12.0 mm
14.0 mm
16.0 mm | range of the
predicates
devices;
therefore, the
dimensions for
the proposed
devices are
substantially
equivalent to the
predicates
devices |
| Single Use | Yes | Yes | Yes | Similarity |
| Sterility | Sterile
(Shelf life: 8 years) | Non-sterile
(Sterilize before use) | Non-sterile
(Sterilize before use) | Different |
| Principle of
Operation | The function of
proposed devices is
used in application
for maintaining the
relative position of
and/or bone grafts in
reconstruction of
maxillary and/or
mandibular areas | The function of
predicate devices is
used in application
for maintaining the
relative position of
and/or bone grafts in
reconstruction of
maxillary and/or
mandibular areas | The function of
predicate devices is
used in application
for maintaining the
relative position of
and/or bone grafts in
reconstruction of
maxillary and/or
mandibular areas | Similarity |
| S.E. | Similarities | The proposed devices have similar indications for use with that of the primary predicate,
Straumann GBR System of Straumann USA (K011698). The proposed devices have
similar principle of operation which is to function for maintaining the relative position of
and/or bone grafts in reconstruction of maxillary and/or mandibular areas. The proposed
devices are made with same material and have similar designs compared to that of the
predicates. The proposed devices are single use only which is the same way as the | | |
5
Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small orange circle above the "M". Below "OSSTEM" is the word "IMPLANT" 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
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
| predicates. |
|---|
| Differences |
| The proposed devices have different dimensions compared to that of the predicates, but |
| the range of screw diameter and screw length is within the permissible range of the |
| predicates devices, Straumann GBR System of Straumann USA (K011698) and Jeil |
| Bone Fixation System of Jeil Medical Corporation (K050669). The proposed devices are |
| gamma sterilized while the predicates are delivered in non-sterile which required |
| sterilization prior to use. |
| .: While given dimensions are different with that of the predicates (K011698 and |
| K050669), the proposed devices have similar indications for use, similar shape and |
| principle of operation; and are made with same materials compared to that of the |
| described predicates. Therefore, the proposed devices are substantially equivalent to the |
| predicates above. |
| Bone Tack | ACE Tru-FIX Implant System | Remark | |
|---|---|---|---|
| 510(K) | Proposed | Reference Device (K080074) | - |
| Manufacturer | Osstem Implant Co., Ltd. | ACE Surgical Supply Co., Inc. | Different |
| Design | Image: Bone Tack | Image: ACE Tru-FIX Implant System | Similarity |
| Indications | |||
| for Use | |||
| Statement | It is indicated for use to stabilize | ||
| and support bone graft and/or | |||
| fractured bone segments with or | |||
| without bone plates or titanium | |||
| mesh in oral and maxillofacial | |||
| site defects. | It is indicated for use to stabilize | ||
| and support bone graft and/or | |||
| fractured bone segments with or | |||
| without bone plates or titanium | |||
| mesh in oral and maxillofacial | |||
| site defects. | Similarity | ||
| Material | Titanium Alloy | ||
| (Ti-6Al-4V, ASTM F136) | Titanium Alloy | ||
| (Ti-6Al-4V, ASTM F136) | Similarity | ||
| Head Diameter | 2.5 mm | 2.5 mm | Similarity |
| Length | 3.0 mm | 3.0 mm | |
| 5.0 mm | Similarity | ||
| Single Use | Yes | Yes | Similarity |
| Sterility | Sterile | ||
| (Shelf life: 8 years) | Sterile | ||
| (Shelf life: unknown) | Similarity | ||
| Principle of | |||
| Operation | The function of proposed device | ||
| is used in application for fixating | |||
| or stabilizing barrier membranes | |||
| in GBR | The function of proposed device | ||
| is used in application for fixating | |||
| or stabilizing barrier membranes | |||
| in GBR | Similarity | ||
| S.E. | Similarities |
7
Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, with the letters connected in a stylized way. Below "OSSTEM" is the word "IMPLANT" in gray, in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company name.
SSTEM Implant Co.. Ltd.
16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea 'el: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com
| | The proposed device has same indication and function, and is made of same material
compared to that of the predicate device, ACE Tru-FIX Implant System of ACE Surgical
Supply Co., Inc. (K080074). Proposed device has same head diameter and length, and
supplied in sterile compared to that of the predicate device. |
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Differences |
| | The proposed device has one length option while the predicates have two options in
length with having same diameter. |
| | : The proposed device has same dimension, made of same material, and has similar
indications and priniciple of operation compared to that of the predicate device;
therefore, the proposed device is substantially equivalent to the predicate above. |
-
- Indications for Use
Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.
- Indications 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 testing was considered following 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"and the ISO 10993 suite of standards and leveraged from reference device K172354.
Sterilization Validation and Shelf-life
All subject devices are delivered sterile. Sterilization validation and shelf-life was considered following the ISO 11137 and ISO 11607 suites of standards. Endotoxin batch testing is in place per the FDA Guidance Document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Mechanical Properties Mechanical testing was evaluated following ASTM F543 with the worst case scenario.
-
- Summary of Clinical Testing
No clinical studies are submitted.
- Summary of Clinical Testing
8
Image /page/8/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" also appearing in orange next to the word "IMPLANT" in gray. Below the logo is the company's address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, along with their telephone number (+82 51 850 2500), fax number (+82 51 861 4693), and website address (www.osstem.com).
9. 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 Bone Screw and Bone Tack are substantially equivalent to the predicated devices as herein.