Who is the manufacturer of Membrane Screws and Membrane Tacks?

Neoss Limited filed the 510(k) submission for Membrane Screws and Membrane Tacks (K201561).

What is the FDA product code for Membrane Screws and Membrane Tacks?

DZL. It is classified under 21 CFR 872.4880 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Membrane Screws and Membrane Tacks?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Membrane Screws and Membrane Tacks?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Membrane Screws and Membrane Tacks

Q: What are the predicate devices for Membrane Screws and Membrane Tacks?

Meisinger Tacs, Hager and Meisinger GmbH (K130682); Pro-fix Membrane Fixation Screws, Osteogenics (K093719).

K201561 · Neoss Limited · DZL · Oct 5, 2020 · Dental

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
Attributes	Therapeutic

Intended 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)

Related Devices

K182881 — Bone Screw, Bone Tack · Osstem Implant Co., Ltd. · Aug 9, 2019
K130682 — MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT · Hager& Meisinger GmbH · Aug 13, 2013
K251569 — Bone Screw · Osstem Implant Co., Ltd. · Aug 13, 2025
K092855 — MILTEX MEMBRANE TACK KIT · Miltex, Inc. · Dec 29, 2009
K151540 — MC BIO Supertack Tack 3mm, 4mm and 5mm · Eli-Ka Technologies · May 26, 2016

Submission Summary (Full Text)

{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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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. {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 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 {2}------------------------------------------------ ## 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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 Windsor House Cornwall Road Harrogate, HG1 2PW, UK Establishment Registration Number: 3005846524 | |----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Cherita James M Squared Associates, Inc. 127 West 30th St 9th Floor New York, New York 10001 Ph: 347-954-0624 Fax: 702-562-9797 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. {4}------------------------------------------------ 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 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 similar and suitable for their intended use. | | Product Code | DZL Intraosseous fixation screw | DZL Intraosseous fixation screw | Substantially equivalent | | Intended Use | Membrane Tacks 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. | Meisinger Tacs are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure. Tacs are intended for single use only. | Substantially equivalent. Both devices have the same intended use (membrane fastening) for the same anatomical site (oral cavity) during bone regeneration. Though not specified by Neoss, the membrane tacks are intended for use with both resorbable membranes nonresorbable membranes. Meisinger has not specified the duration and implantation details however this | | | Neoss | Hager and Meisinger GmbH | Substantial Equivalence | | | | | can be assumed by the intention of the application of a dental membrane. The differences in the indication statements do not represent a difference in the intended use clinically and do not affect the safety and effectiveness of the subject device. | | Material Composition | Titanium alloy grade 5 (ASTM F136) | Titanium alloy grade 5 (ASTM F136) | Substantially equivalent | | Dimensions | Head diameter 2.5mm, Length 3.0mm | Head diameter 2.5mm, Length 3.5mm | The Neoss device is within the range of dimensions of the predicate and other commercially available tacks | | Handling and placement | Pick up the Tack by firmly pushing the Tack Positioning Instrument, Insert thru membrane and gently tap Tack with mallet | Pick up the Tack by firmly pushing the Tack Positioning Instrument, Insert thru membrane and gently tap with mallet | | | Removal | pry the head of the Tack from the underlying membrane using a thin and flat tool, such as a scalpel blade. | Unknown for Tacs | The Neoss Membrane Tack is removed by similar methods to currently marketed dental membrane tacks. | | Bone stability | Barbed tip | Barbed tip | Substantially equivalent | | Duration of use | 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. | unknown | The duration of use for the Neoss products is the same as other commercially available tacks, they are intended to be removed at the time healing is achieved | | Sterility | sterile | delivered non-sterile/ autoclavable | Packaging, sterilization and transport have been validated. | | Reprocessing | No - single use | No – single use | Substantially equivalent | | Biocompatible | Yes, materials and manufacturing process | Yes, materials | Neoss Tacks manufacturing processes and cleaning | | Neoss | Hager and Meisinger GmbH | Substantial Equivalence | | | | | materials are evaluated for biocompatibility for their intended use. | | | | | Meisinger processing is unknown, but material is the same. | | {5}------------------------------------------------ {6}------------------------------------------------ | | Neoss | Osteogenics | Substantial Equivalence | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Membrane Screw | Pro-Fix Screw (only) | | | 510(k) No. | K201561 | K093719 | | | Product Code | DZL Intraosseous fixation screw | DZL Intraosseous fixation screw | Substantially equivalent | | | Image: Membrane Screw | Image: Pro-Fix Screw | Device designs are similar and suited for intended use. | | Intended Use | 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. | The Pro-FixTM Precision Fixation System is used to stabilize, fixate and/or support bone grafts, bone filling materials and/or barrier membranes used for regeneration of bone in the oral cavity. | Same intended use for fixation of membranes only. Osteogenics has not specified the duration and implantation details however this can be assumed by the intention of the application of a dental membrane. The differences in the indication statements do not represent a difference in the intended use clinically and do not affect the safety and effectiveness of the subject device. | | Material Composition | Titanium alloy grade 5 (ASTM F136) | Titanium alloy grade 5 (ASTM F136) | Same material | | Dimensions | Diameter Head 2.6mm, Thread 1.5mm & length 3.2mm | Diameter: Thread 1.5mm, length 3.mm | Comparable screw dimensions and performance testing confirms adequate for intended use | | | Neoss | Osteogenics | Substantial | | | | | Equivalence | | Handling and placement | Pick up the Screw by firmly pushing the tip of a Neoss Implant Inserter into the head of the Screw, Insert the Screw through the membrane into the bone applying a torque of less than 10 Ncm. | Cruciform driver | Neoss has confirmed instrument performs as intended for placement. | | Removal | unscrew the Membrane Screws using the tip of a Neoss Implant Inserter | Unknown | Neoss has confirmed instrument performs as intended for removal | | Duration of use | 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. | 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 | Substantially equivalent duration of use | | Sterility | sterile | sterile | Substantially equivalent | | Reprocessing | No-single use | No-single use | Substantially equivalent | | Biocompatible | Yes, material and manufacturing processes | Yes, materials | Neoss Tacks manufacturing processes and materials are evaluated for biocompatibility for their intended use. Osteogenics processing is unknown, but material is the same. | {7}------------------------------------------------ {8}------------------------------------------------ ## 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 — Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices | 14-428 | | EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2 Establishing the sterilization dose | 14-409 | | ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: 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 {9}------------------------------------------------ (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.