(298 days)
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.
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. Bone Tack is a stabilizer that can stably fix the membrane in GBR.
The provided document is an FDA 510(k) Premarket Notification summary for a Bone Screw and Bone Tack device. It generally discusses the device's substantial equivalence to predicate devices based on non-clinical testing. However, it explicitly states that no clinical studies were submitted and therefore does not contain information about acceptance criteria or a study proving the device meets them through clinical performance.
Therefore, I cannot provide details for most of your requested points, as they pertain to clinical or comparative effectiveness studies that were not performed or reported in this document.
Here's what can be extracted based on the information provided, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify acceptance criteria for clinical performance or any reported device performance that would meet such criteria. It focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical testing.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical test set was used or reported in this submission. The non-clinical testing details do not specify sample sizes in a way that aligns with "test set" for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No clinical test set or ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical test set or adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. No MRMC study was done, and the device is a medical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. The device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical ground truth was established as no clinical studies were performed.
8. The sample size for the training set
- Cannot be provided. No training set for an algorithm was used.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth for it was established.
Summary of what the document does provide regarding testing:
The manufacturer performed non-clinical testing to support the substantial equivalence claim. These include:
- Biocompatibility evaluation: Considered following FDA Guidance Document Use of International Standard ISO 10993-1 and ISO 10993 suite of standards. This leveraged information from reference device K172354.
- Sterilization Validation and Shelf-life: Considered following 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: Evaluated following ASTM F543 with a "worst-case scenario."
The document explicitly states: "No clinical studies are submitted." (Page 7, Section 8)
Therefore, based solely on the provided text, no information is available about clinical acceptance criteria or studies proving device performance against such criteria. The submission relies on substantial equivalence to predicate devices and non-clinical testing.
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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 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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)
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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)
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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 bonematerial or block bone for bone regeneration or remodeling. Ø1.4 diameterscrew is for fixing membrane or bone plate, and Ø2.0 diameter screw is forfixing 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 | StraumannGBR System | Jeil BoneFixation System | Remark | |
|---|---|---|---|---|
| 510(k) | Proposed | Primary Predicate(K011698) | Reference Device(K050669) | - |
| Manufacturer | Osstem ImplantCo., Ltd. | Straumann USA | Jeil MedicalCorporation | - |
| Design | Image: Bone Screw | Image: Straumann GBR System | Image: Jeil Bone Fixation System | Similarity |
| Indicationsfor UseStatement | Bone Screw is usedto stabilize and fixatebone grafts, bonefilling material,and/or barriermembranes used forregeneration of bonein the oral cavity. | The StraumannGuided BoneRegeneration (GBR)System is used tostabilize and fixatebone grafts, bonefilling materials,and/or barrier | The device isintended for use instabilizing andfixating bone grafts,bone filling materialand/or barriermembranes used forguided bone/tissue | Similarity.Small changesare due todifferences incomponent-specificlanguage. |
| membranes used forregeneration of bonein the oral cavity.The GBR techniquecan make it possiblefor the placement ofdental implants inpreviously unsuitablesites. | regeneration in theoral cavity. Singlepatient 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 thatof the referencedevice |
| ScrewDiameter | 1.4 mm1.95 mm | 1.2 mm1.5 mm | 1.4 mm1.6 mm2.0 mm | Different but therange of screwdiameter and thescrew length iswithin thepermissible |
| Screw Length | Ø1.4:4.0 mm6.0 mm8.0 mmØ1.95:8.0 mm10.0 mm12.0 mm14.0 mm16.0 mm | 3.0 mm4.0 mm5.0 mm7.0 mm8.0 mm9.0 mm10.0 mm12.0 mm14.0 mm | 4.0 mm5.0 mm6.0 mm8.0 mm10.0 mm12.0 mm14.0 mm16.0 mm | range of thepredicatesdevices;therefore, thedimensions forthe proposeddevices aresubstantiallyequivalent to thepredicatesdevices |
| Single Use | Yes | Yes | Yes | Similarity |
| Sterility | Sterile(Shelf life: 8 years) | Non-sterile(Sterilize before use) | Non-sterile(Sterilize before use) | Different |
| Principle ofOperation | The function ofproposed devices isused in applicationfor maintaining therelative position ofand/or bone grafts inreconstruction ofmaxillary and/ormandibular areas | The function ofpredicate devices isused in applicationfor maintaining therelative position ofand/or bone grafts inreconstruction ofmaxillary and/ormandibular areas | The function ofpredicate devices isused in applicationfor maintaining therelative position ofand/or bone grafts inreconstruction ofmaxillary and/ormandibular 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 havesimilar principle of operation which is to function for maintaining the relative position ofand/or bone grafts in reconstruction of maxillary and/or mandibular areas. The proposeddevices are made with same material and have similar designs compared to that of thepredicates. The proposed devices are single use only which is the same way as the |
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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 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
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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
| predicates. |
|---|
| Differences |
| The proposed devices have different dimensions compared to that of the predicates, butthe range of screw diameter and screw length is within the permissible range of thepredicates devices, Straumann GBR System of Straumann USA (K011698) and JeilBone Fixation System of Jeil Medical Corporation (K050669). The proposed devices aregamma sterilized while the predicates are delivered in non-sterile which requiredsterilization prior to use. |
| .: While given dimensions are different with that of the predicates (K011698 andK050669), the proposed devices have similar indications for use, similar shape andprinciple of operation; and are made with same materials compared to that of thedescribed predicates. Therefore, the proposed devices are substantially equivalent to thepredicates 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 |
| Indicationsfor UseStatement | It is indicated for use to stabilizeand support bone graft and/orfractured bone segments with orwithout bone plates or titaniummesh in oral and maxillofacialsite defects. | It is indicated for use to stabilizeand support bone graft and/orfractured bone segments with orwithout bone plates or titaniummesh in oral and maxillofacialsite 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 mm5.0 mm | Similarity |
| Single Use | Yes | Yes | Similarity |
| Sterility | Sterile(Shelf life: 8 years) | Sterile(Shelf life: unknown) | Similarity |
| Principle ofOperation | The function of proposed deviceis used in application for fixatingor stabilizing barrier membranesin GBR | The function of proposed deviceis used in application for fixatingor stabilizing barrier membranesin GBR | Similarity |
| S.E. | Similarities |
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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 materialcompared to that of the predicate device, ACE Tru-FIX Implant System of ACE SurgicalSupply Co., Inc. (K080074). Proposed device has same head diameter and length, andsupplied in sterile compared to that of the predicate device. | |
|---|---|
| Differences | |
| The proposed device has one length option while the predicates have two options inlength with having same diameter. | |
| : The proposed device has same dimension, made of same material, and has similarindications 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
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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.
§ 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.