(29 days)
Not Found
No
The device description explicitly states "The device does not contain software/firmware," and there are no mentions of AI, ML, or related concepts in the summary.
Yes
The device is described as an "implantable non-active device" intended for "fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee," directly indicating its use in treating a medical condition.
No
Explanation: The WasherCap™ Fixation System is described as an implantable non-active device intended for fixation of soft tissue grafts during surgical procedures. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states that the device does not contain software/firmware and is composed of physical implantable components (washer, cap, screw) and reusable surgical instruments.
Based on the provided information, the WasherCap™ Fixation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is described as an "implantable non-active device" made of materials like PEEK and Titanium Alloy. These are typical materials for surgical implants.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The WasherCap™ Fixation System does not perform any such function.
Therefore, the WasherCap™ Fixation System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surqical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The WasherCap™ Fixation System is an implantable non-active device consisting of three components: the washer, the cap, and the screw. All components building the WasherCap™ Fixation System are made of high-quality biocompatible materials, with a long-existence use in terms of human safety and patient's clinical performance.
The Washer and the Cap are made from non-degradable organic thermoplastic polymer biomaterial, so-called Polietheretherketone (PEEK by Invibio™ Biomaterial Solutions in accordance with ASTM 2026) and the Screw is made from implantable degree Titanium Alloy (Ti-6Al- 4V ELI) in accordance with ISO 5832-3 and ASTM F136 standards.
To achieve correct implantation and use of the device requires specific accessories: WasherCap™ Instrument Set. The required accessories are product- specific reusable surgical instruments that have been designed for the implantation of the WasherCap™ Fixation System. Use of the WasherCap™ Instrument Set will ensure the surgical procedure, and the use of the WasherCap™ Fixation System are carried out in an appropriate manner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Mechanical testing verifications were performed on the proposed WasherCap™ Fixation System 11mm implant to ensure device performance was identical to that of the predicate (K212197). Testing was performed using the same acceptance criteria and protocols used in the predicate submission. The proposed device was found to be substantially equivalent in performance compared to its predicate.
This submission does not include any animal performance testing. It was determined that no such testing is required to demonstrate substantial equivalence.
This submission does not include any clinical performance testing. It was determined that no such testing is required to demonstrate substantial equivalence.
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2025
Abanza Tecnomed S.1 % Jessica Czamanski Regulatory Consultant Precision Life Science Partners 300 Creek View Road Newark, Delaware 19711
Re: K250238
Trade/Device Name: WasherCap™ Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 24, 2025 Received: January 27, 2025
Dear Jessica Czamanski:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 postmarketing 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 (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Thomas Mcnamara -S
For: Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
WasherCap™ Fixation System
Indications for Use (Describe)
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surqical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
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."
4
Image /page/4/Picture/0 description: The image shows the logo for ABANZA. The logo consists of a stylized blue shape on the left, resembling a curved, elongated form with intersecting lines. To the right of the shape is the word "ABANZA" in a blue, sans-serif font. The overall design is clean and modern.
WahserCap™ Fixation System – 510(k) Summary
l. Submitter
| Submitter Name: | Anbanza Tecnomed, S.L. |
|---|---|
| Contact Person: | Ander Menaut |
| RD Manager | |
| Address: | Calle Nueva 29 |
| Multiva, ES, 31192 | |
| Spain | |
| Telephone: | (+34) 948-044-643 |
| Email: | regulatory@abanzamed.com |
| Date of Preparation: | January 24, 2025 |
II. Application Correspondent
| Contact's Name: | Precision Life Sciences Partners LLC |
|---|---|
| Contact Person: | Jessica Czamanski |
| Address: | 300 Creek View Road |
| Newark, DE, 19711 | |
| USA | |
| Telephone: | (754) 422-9101 |
| Email: | jczamanski@plsp.pro |
lll. Device
| Trade Name: | WasherCap™ Fixation System |
|---|---|
| Common Name: | Non-Degradable Soft Tissue Fixation Device |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Product Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | MBI |
IV. Predicate Device
| Manufacturer: | Abanza Tecnomed, S.L. |
|---|---|
| Device Name: | WasherCap™ Fixation System |
| 510(k) Number: | K212197 |
| Product Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | MBI |
5
Image /page/5/Picture/0 description: The image shows the logo for Avanza. The logo consists of a stylized blue icon on the left and the word "ABANZA" in blue on the right. The icon appears to be an abstract shape with curved lines, possibly representing movement or growth. The font used for the word "ABANZA" is a clean, sans-serif typeface.
V. Device Description
The WasherCap™ Fixation System is an implantable non-active device consisting of three components: the washer, the cap, and the screw. All components building the WasherCap™ Fixation System are made of high-quality biocompatible materials, with a long-existence use in terms of human safety and patient's clinical performance.
The Washer and the Cap are made from non-degradable organic thermoplastic polymer biomaterial, so-called Polietheretherketone (PEEK by Invibio™ Biomaterial Solutions in accordance with ASTM 2026) and the Screw is made from implantable degree Titanium Alloy (Ti-6Al- 4V ELI) in accordance with ISO 5832-3 and ASTM F136 standards.
To achieve correct implantation and use of the device requires specific accessories: WasherCap™ Instrument Set. The required accessories are product- specific reusable surgical instruments that have been designed for the implantation of the WasherCap™ Fixation System. Use of the WasherCap™ Instrument Set will ensure the surgical procedure, and the use of the WasherCap™ Fixation System are carried out in an appropriate manner.
VI. Intended Use
The WasherCap™ Fixation System is intended for fixation of soft tissue grafts to bone.
VII. Indications for Use
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
VIII. Comparison of Technological Characteristics
The proposed WasherCap™ Fixation System is identical to its predicate, except for a 1mm difference which will allow compatibility with the full range of tendon grafts used in ACL reconstruction surgery, which spans 6mm – 11mm. The subject device includes accessories sized appropriately to effectively use the 11mm implant.
All materials and manufacturing processes are identical to those used for the predicate.
IX. Sterilization
There are no differences in the sterilization process between the subject and predicate device.
6
Image /page/6/Picture/0 description: The image shows the Abanza logo, which consists of a blue abstract shape on the left and the word "ABANZA" in blue capital letters on the right. Below the logo, there is the text "X. Performance Data" in black. The text is left-aligned and appears to be a section heading or title.
All performance data for the WasherCap™ Fixation System was obtained using the same validated methodology used in the predicate submission (K212197).
Performance Testing - Bench
Mechanical testing verifications were performed on the proposed WasherCap™ Fixation System 11mm implant to ensure device performance was identical to that of the predicate (K212197). Testing was performed using the same acceptance criteria and protocols used in the predicate submission. The proposed device was found to be substantially equivalent in performance compared to its predicate.
Biocompatibility
There is no change in materials or manufacturing of the WasherCap™ Fixation System. The biocompatibility data in the predicate submission (K212197) support the subject device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility have not been evaluated.
Software Verification and Validation
The device does not contain software/firmware.
Performance Testing - Animal
This submission does not include any animal performance testing. It was determined that no such testing is required to demonstrate substantial equivalence.
Performance Testing - Clinical
This submission does not include any clinical performance testing. It was determined that no such testing is required to demonstrate substantial equivalence.
XI. Conclusion
The proposed WasherCap™ Fixation System has the same intended use, indications for use, operating principle, fundamental technology, materials, and manufacturing as the predicate device. Additional testing was performed to ensure performance of the proposed 11mm implant and
7
Image /page/7/Picture/0 description: The image shows the logo for ABANZA. The logo consists of a stylized, abstract shape on the left, resembling a network or interconnected structure, rendered in shades of blue. To the right of the shape is the word "ABANZA" in a sans-serif font, also in blue. The overall design is clean and modern.
associated instruments is identical to the predicate, and that the addition of the new size does not introduce new questions for safety and effectiveness. The information provided in this submission demonstrated that the subject device, WasherCap™ Fixation System, is substantially equivalent to its predicate, WasherCap™ Fixation System K212197.