Membrane Screws and Membrane Tacks
Device Facts
| Record ID | K201561 |
|---|---|
| Device Name | Membrane Screws and Membrane Tacks |
| Applicant | Neoss Limited |
| Product Code | DZL · Dental |
| Decision Date | Oct 5, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4880 |
| Device Class | Class 2 |
Indications for Use
Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of implantation of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
Device Story
Membrane Tacks and Membrane Screws are titanium alloy (ASTM F136) fasteners used in oral surgery to secure regenerative membranes over bone defects. Tacks are applied via a Tack Positioning Instrument using a mallet; screws are applied via a Neoss Implant Inserter. Devices are single-use, sterile, and intended for temporary implantation (3-9 months) until bone regeneration is complete. Upon healing, tacks are removed using a flat tool (e.g., scalpel); screws are removed by unscrewing with the inserter. Used by dental clinicians in clinical settings to prevent soft tissue ingrowth into bone grafts, facilitating bone repair.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing, including insertion/removal force evaluations, insertion torque testing, and sterilization/biocompatibility validation per ISO 10993-1 and EN ISO 11137 standards.
Technological Characteristics
Materials: Titanium alloy grade 5 (ASTM F136). Form factor: 3mm length tacks/screws. Sterilization: Gamma irradiation (25 kGy, SAL 10^-6). Packaging: PET blister with peel-open lid. Connectivity: None. Software: None.
Indications for Use
Indicated for fastening membranes during bone regenerative treatment in the oral cavity. Intended for temporary, submerged implantation (30 days to 9 months) until bone regeneration is complete.
Regulatory Classification
Identification
An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.
Predicate Devices
- Meisinger Tacs, Hager and Meisinger GmbH (K130682)
- Pro-fix Membrane Fixation Screws, Osteogenics (K093719)
Reference Devices
- Neoss Implant System (K083561)
- Neoss Implant System (K090452)
- Neoss Implant System (K113376)
- Neoss Access Abutment (K081851)
- Crystaloc Abutment Screw (K150669)
Submission Summary (Full Text)
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October 5, 2020
Neoss Limited c/o Cherita James Regulatory Consultant M Squared Associates, Inc. 127 West 30th St. Floor 9 New York, New York 10001
Re: K201561
Trade/Device Name: Membrane Screws and Membrane Tacks Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: September 23, 2020 Received: September 25, 2020
Dear Cherita James:
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 Part 803) for devices or post-marketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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.
for Srinivas Nandkumar, Ph.D. 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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## Indications for Use
510(k) Number (if known) K201561
#### Device Name Membrane Tacks and Membrane Screws
#### Indications for Use (Describe)
Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
Type of Use (Select one or both, as applicable)
| <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## 510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for the Membrane Tacks and Membrane Screws 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | Neoss Ltd<br>Windsor House<br>Cornwall Road<br>Harrogate, HG1 2PW, UK<br>Establishment Registration Number: 3005846524 |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cherita James<br>M Squared Associates, Inc.<br>127 West 30th St<br>9th Floor<br>New York, New York 10001<br>Ph: 347-954-0624<br>Fax: 702-562-9797<br>E-mail: CJames@MSquaredAssociates.com |
| Date of Submission: | October 2, 2020 |
|----------------------|--------------------------------------------------|
| Proprietary Name: | Membrane Tacks and Membrane Screws |
| Common Name: | Intraosseous Tacks, Screws |
| Regulatory Class: | II |
| Regulation: | 872.4880 |
| Product Code: | DZL |
| Predicate Device(s): | Meisinger Tacs, Hager and Meisinger GmbH K130682 |
Pro-fix Membrane Fixation Screws, Osteogenics K093719
Device Description: Membrane Tacks and Membrane Screws are regenerative membrane fastening devices available in 3mm length. The Membrane Tack is used in conjunction with a Tack Positioning Instrument, while the Membrane Screw is applied with the Neoss Implant Inserter. Regenerative membranes are designed to prevent ingrowth of gingival soft tissue into bony defects, in order to facilitate the bone formation during the repair process of the defect. Membrane Tacks and Screws are made of titanium while related instruments are made in stainless steel. The Membrane fastening devices are single-use only while the instruments are for multiple use.
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Indications for Use: Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of implantation of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
## Comparison to predicate device.
The claim of substantial equivalence of the Membrane Tacks and Membrane Screws to the products identified above is based on the comparison of the intended use, product technical characteristics, performance characteristics and product handling.
| | Neoss | Hager and Meisinger GmbH | Substantial<br>Equivalence |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Membrane Tack | Meisinger Tac (only) | |
| 510(k) No. | K201561 | K130682 | |
| | Image: Neoss Membrane Tack | Image: Hager and Meisinger GmbH Meisinger Tac | Device designs are<br>similar and suitable for<br>their intended use. |
| Product Code | DZL Intraosseous fixation<br>screw | DZL Intraosseous fixation screw | Substantially<br>equivalent |
| Intended Use | Membrane Tacks are<br>intended for fastening<br>membranes during bone<br>regenerative treatment.<br>These membrane fastening<br>means are in direct body<br>contact, intended for<br>temporary use only.<br>Membrane fastening means<br>are submerged and<br>clinically implanted more<br>than 30 days with an<br>expected duration of<br>implantation of three to<br>nine months or until bone<br>regeneration is complete<br>taking into account which<br>membrane and bone<br>grafting materials are being<br>used. | Meisinger Tacs are used for the<br>fixation of membranes<br>(resorbable membranes<br>nonresorbable membranes) to the<br>bone structure. Tacs are intended<br>for single use only. | Substantially<br>equivalent.<br>Both devices have the<br>same intended use<br>(membrane fastening)<br>for the same<br>anatomical site (oral<br>cavity) during bone<br>regeneration.<br>Though not specified<br>by Neoss, the<br>membrane tacks are<br>intended for use with<br>both resorbable<br>membranes<br>nonresorbable<br>membranes.<br>Meisinger has not<br>specified the duration<br>and implantation<br>details however this |
| | Neoss | Hager and Meisinger GmbH | Substantial<br>Equivalence |
| | | | can be assumed by the<br>intention of the<br>application of a dental<br>membrane.<br><br>The differences in the<br>indication statements<br>do not represent a<br>difference in the<br>intended use clinically<br>and do not affect the<br>safety and<br>effectiveness of the<br>subject device. |
| Material<br>Composition | Titanium alloy grade 5<br>(ASTM F136) | Titanium alloy grade 5 (ASTM<br>F136) | Substantially<br>equivalent |
| Dimensions | Head diameter 2.5mm,<br>Length 3.0mm | Head diameter 2.5mm, Length<br>3.5mm | The Neoss device is<br>within the range of<br>dimensions of the<br>predicate and other<br>commercially<br>available tacks |
| Handling and<br>placement | Pick up the Tack by firmly<br>pushing the Tack<br>Positioning Instrument,<br>Insert thru membrane and<br>gently tap Tack with mallet | Pick up the Tack by firmly<br>pushing the Tack Positioning<br>Instrument, Insert thru membrane<br>and gently tap with mallet | |
| Removal | pry the head of the Tack<br>from the underlying<br>membrane using a thin and<br>flat tool, such as a scalpel<br>blade. | Unknown for Tacs | The Neoss Membrane<br>Tack is removed by<br>similar methods to<br>currently marketed<br>dental membrane<br>tacks. |
| Bone stability | Barbed tip | Barbed tip | Substantially<br>equivalent |
| Duration of use | implanted more than 30<br>days with an expected<br>duration of implantation of<br>three to nine months or<br>until bone regeneration is<br>complete taking into<br>account which membrane<br>and bone grafting materials<br>are being used. | unknown | The duration of use for<br>the Neoss products is<br>the same as other<br>commercially<br>available tacks, they<br>are intended to be<br>removed at the time<br>healing is achieved |
| Sterility | sterile | delivered non-sterile/<br>autoclavable | Packaging,<br>sterilization and<br>transport have been<br>validated. |
| Reprocessing | No - single use | No – single use | Substantially<br>equivalent |
| Biocompatible | Yes, materials and<br>manufacturing process | Yes, materials | Neoss Tacks<br>manufacturing<br>processes and<br>cleaning |
| Neoss | Hager and Meisinger GmbH | Substantial<br>Equivalence | |
| | | materials are evaluated<br>for biocompatibility<br>for their intended use. | |
| | | Meisinger processing<br>is unknown, but<br>material is the same. | |
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| | Neoss | Osteogenics | Substantial<br>Equivalence |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Membrane Screw | Pro-Fix Screw (only) | |
| 510(k) No. | K201561 | K093719 | |
| Product Code | DZL Intraosseous fixation screw | DZL Intraosseous fixation<br>screw | Substantially equivalent |
| | Image: Membrane Screw | Image: Pro-Fix Screw | Device designs are<br>similar and suited for<br>intended use. |
| Intended Use | Membrane Screws are intended<br>for fastening membranes during<br>bone regenerative treatment.<br>These membrane fastening means<br>are in direct body contact,<br>intended for temporary use only.<br>Membrane fastening means are<br>submerged and clinically<br>implanted more than 30 days with<br>an expected duration of<br>implantation of three to nine<br>months or until bone regeneration<br>is complete taking into account<br>which membrane and bone<br>grafting materials are being used. | The Pro-FixTM Precision<br>Fixation System is used to<br>stabilize, fixate and/or support<br>bone grafts, bone filling<br>materials and/or barrier<br>membranes used for<br>regeneration of bone in the<br>oral cavity. | Same intended use for<br>fixation of membranes<br>only.<br>Osteogenics has not<br>specified the duration<br>and implantation details<br>however this can be<br>assumed by the<br>intention of the<br>application of a dental<br>membrane.<br>The differences in the<br>indication statements do<br>not represent a<br>difference in the<br>intended use clinically<br>and do not affect the<br>safety and effectiveness<br>of the subject device. |
| Material<br>Composition | Titanium alloy grade 5 (ASTM<br>F136) | Titanium alloy grade 5<br>(ASTM F136) | Same material |
| Dimensions | Diameter Head 2.6mm, Thread<br>1.5mm & length 3.2mm | Diameter: Thread 1.5mm,<br>length 3.mm | Comparable screw<br>dimensions and<br>performance testing<br>confirms adequate for<br>intended use |
| | Neoss | Osteogenics | Substantial |
| | | | Equivalence |
| Handling and<br>placement | Pick up the Screw by firmly<br>pushing the tip of a Neoss<br>Implant Inserter into the head of<br>the Screw, Insert the Screw<br>through the membrane into the<br>bone applying a torque of less<br>than 10 Ncm. | Cruciform driver | Neoss has confirmed<br>instrument performs as<br>intended for placement. |
| Removal | unscrew the Membrane Screws<br>using the tip of a Neoss Implant<br>Inserter | Unknown | Neoss has confirmed<br>instrument performs as<br>intended for removal |
| Duration of use | implanted more than 30 days with<br>an expected duration of<br>implantation of three to nine<br>months or until bone regeneration<br>is complete taking into account<br>which membrane and bone<br>grafting materials are being used. | implanted more than 30 days<br>with an expected duration of<br>implantation of three to nine<br>months or until bone<br>regeneration is complete<br>taking into account which<br>membrane and bone grafting<br>materials are being used | Substantially equivalent<br>duration of use |
| Sterility | sterile | sterile | Substantially equivalent |
| Reprocessing | No-single use | No-single use | Substantially equivalent |
| Biocompatible | Yes, material and manufacturing<br>processes | Yes, materials | Neoss Tacks<br>manufacturing processes<br>and materials are<br>evaluated for<br>biocompatibility for<br>their intended use.<br>Osteogenics processing<br>is unknown, but<br>material is the same. |
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## Technological Characteristics
The Membrane Screws and Membrane Tacks are substantially equivalent to the predicates identified above with regard to materials, dimensions, product packaging and placement and removal methods.
Both Membrane Tacks and Screws, like the predicate devices, are provided in a sterile form.
## Performance Testing
Membrane Screws and Membrane Tacks are in conformity with the following standards.
| Standard | Recognition Number |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| EN ISO 11137-1:2015 Sterilization of health care products — Radiation —<br>Part 1 Requirements for development, validation and routine control of a<br>sterilization process for medical devices | 14-428 |
| EN ISO 11137-2:2015 Sterilization of health care products — Radiation —<br>Part 2 Establishing the sterilization dose | 14-409 |
| ISO 10993-1:2018 Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management process. | 2-258 |
Sterilization: A dose of 25 kGy is chosen as sterilization dose by gamma irradiation. Method VDmax25 according to standard EN ISO 11137-2 is applied for all Neoss products that are terminally sterilized (SAL 106). The Membrane Tacks and Screws are manufactured of the same material (Titanium alloy grade 5) and packaged identically to various 510k cleared Neoss Implant System (implants/abutments/screws K083561, K090452, K113376), which would be considered "worst case" for sterilization when compared to the Membrane Tacks and Screws.
Shelf life: Membrane Tacks and Screws are provided sterile for single patient use. They are delivered packaged in a PET blister with peel-open paper lid housed in a protective rigid plastic case. The packaging utilized is a standard packaging for terminally sterilized Neoss Implant Systems. The products sterilized with gamma irradiation and packaged as described above have been verified to support 5 years shelf life (Ageing Validation including accelerated ageing, real time ageing and peel force testing have been performed and are documented to support 5 year shelf life claim).
Biocompatibility: Membrane Tacks and Membrane Screws are characterized as permanent implants (up to 1 year), contacting tissue and bone. No new biocompatibility testing has been performed, as the subject devices are substantially equivalent to Neoss Access Abutment (K081851) and Crystaloc Abutment Screw (K150669) with regards to materials and processing. The Neoss patient contacting instruments
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(implant inserter and tack positioning instrument) only have very brief / transitory contact with the body. No coating or lubricants are left in contact with body tissues after the devices are removed. Per ISO 10993-1:2018 section 5.3.2 such devices do not require biocompatibility testing.
Instrument cleaning and sterilization: Membrane Tack and Screw Cassette, Tack Positioning Instrument and Neoss Implant Inserter cleaning and sterilization recommendations were validated on more complex, multicomponent Neoss instruments of the same materials. Cleaning validations included soiling, mechanical cleaning, and residual testing for hemoglobin and protein. Sterilization parameters were evaluated to a SAL 10 ° using the biological indicator overkill method. Test articles were inoculated as outlined in AAMI TIR12 and sterilized using the validated full cycle sterilization parameters and dry time. Validation results confirmed the SAL was achieved with recommended parameters and no evidence of moisture.
Performance evaluations of the Membrane Tacks was conducted to evaluate the insertion and removal forces and found them to be comparable to the predicate device and acceptable for their intended use. Performance evaluations of the Membrane Screws was conducted to evaluate the insertion torque of the device and found them comparable to the values of the predicate device.
Clinical Data: Clinical data is not required to establish substantial equivalence in this submission.
### Conclusion
Membrane Tacks and Membrane Screws substantially equivalent, to the Meisinger Tacs (K130682) and the Osteogenics Pro-fix Membrane Fixation Screws (K093719). They share similar indications for use, technological and performance characteristics.
