(268 days)
No
The description focuses on the mechanical and material properties of the anchor and the ultrasonic energy delivery system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a medical implant intended for suture or tissue fixation, designed to treat medical conditions such as ligament reconstruction and tendon repairs.
No
The device is described as an implantable anchor system used for suture or tissue fixation, specifically for reattaching soft tissue to bone using ultrasonic energy. It is a therapy device, not a diagnostic device.
No
The device description clearly outlines multiple hardware components: an implantable anchor, an ultrasound system, a handpiece tip, and a twist drill. While software validation is mentioned in the performance studies, the device is fundamentally a hardware system with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Fiji Anchor is for "suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder." This describes a surgical implant used to physically attach tissues to bone.
- Device Description: The device description details an implantable anchor, an ultrasound system, a handpiece, and a drill. These are all components of a surgical system used for implantation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening. The Fiji Anchor does not interact with bodily specimens in this way. It is a physical implant used during surgery.
The information provided consistently points to this being a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below:
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Liqament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MAI, HTY, GAT
Device Description
The Fiji anchor system consists of an implantable anchor, an ultrasound system, and handpiece tip, and a twist drill.
The Fiji Anchor is made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,Llactide. The in vivo degradation of the Fiji Anchor is based on the natural physiologic process of hydrolysis, which results in the complete metabolization of the polymer into H₂O and CO2.
The Fiji Anchor is a fully bioresorbable implant designed for soft tissue reattachment to bone by means of suture material. The BoneWelding technology employs ultrasonic energy to liquefy the polymeric components of the Fiji Anchor at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone where it is immediately quenched and provides anchorage of the implant.
The ultrasonic energy for the implantation of the Fiji Anchor is produced by the BoneWelder ultrasonic generator and applied via the attached handpiece. The handpiece tip (sonotrode) is mounted on the handpiece. It transmits the ultrasonic energy to the Fiji Anchor. The twist drill is dedicated to be used with the Fiji Anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, hand, wrist, elbow, and shoulder
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)
The following tests were performed to demonstrate the substantial equivalence of the Fiji Anchor:
- Software documentation and validation per FDA guidance
- IEC 60601-1 and 60601-1-2 testing
- Material characterization using GPC, inherent viscosity, GCMS, and ICP
- Static pullout testing before and after aging
- Dynamic pullout testing before and after aging
- Creep testing
- Extraction and analysis per ISO 10993-18
- Cytotoxicity testing per ISO 10993-5
- Temperature rise in surrounding bone (porcine bone)
- Lot-to-lot endotoxin testing is also performed per USP
Performance data demonstrate that the Fiji Anchor is as safe and effective as Arthrex's Bio-PushLock.
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
January 19, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SportWelding GmbH % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K171228
Trade/Device Name: Fiji Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HTY, GAT Dated: December 13, 2017 Received: December 13, 2017
Dear Ms. Hogan:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K171228 Device Name
Fiji Anchor
Indications for Use (Describe)
The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below:
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Metatarsal Ligament Repair, Hallux Valqus reconstruction, digital tendon transfers. Mid-foot reconstruction
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K171228
510(k) SUMMARY
SportWelding's Fiji Anchor
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sport Welding GmbH Wagistrasse 6 Schlieren, Switzerland
Phone: +41 44 204 61 2821 Facsimile: +41 44 204 61 2820 Contact Person: Joerg Mayer, Managing Director, CTO
Date Prepared: January 17, 2018
Name of Device and Name
Fiji Anchor
Common or Usual Name
Fastener, fixation, biodegradable, soft tissue (MAI), class II
Pin, fixation, smooth (HTY), class II
Suture, nonabsorbable, synthetic, polyethylene (GAT), class II
Classification Name
Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)
Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Nonabsorbable poly(ethylene terephthalate) surgical suture (21 CFR 878.5000)
Predicate Devices
Indications for Use
The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below:
4
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Liqament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Technological Characteristics
The Fiji anchor system consists of an implantable anchor, an ultrasound system, and handpiece tip, and a twist drill.
The Fiji Anchor® is made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,Llactide. The in vivo degradation of the Fiji Anchor® is based on the natural physiologic process of hydrolysis, which results in the complete metabolization of the polymer into H₂O and CO2.
The Fiji Anchor® is a fully bioresorbable implant designed for soft tissue reattachment to bone by means of suture material. The BoneWelding® technology employs ultrasonic energy to liquefy the polymeric components of the Fiji Anchor® at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone where it is immediately quenched and provides anchorage of the implant.
The ultrasonic energy for the implantation of the Fiji Anchor® is produced by the BoneWelder® ultrasonic generator and applied via the attached handpiece. The handpiece tip (sonotrode) is mounted on the handpiece. It transmits the ultrasonic energy to the Fiji Anchor®. The twist drill is dedicated to be used with the Fiji Anchor®.
Performance Data
The following tests were performed to demonstrate the substantial equivalence of the Fiji Anchor:
- Software documentation and validation per FDA guidance
- . IEC 60601-1 and 60601-1-2 testing
- . Material characterization using GPC, inherent viscosity, GCMS, and ICP
- . Static pullout testing before and after aging
- . Dynamic pullout testing before and after aging
- Creep testing
- . Extraction and analysis per ISO 10993-18
5
- Cytotoxicity testing per ISO 10993-5 .
- . Temperature rise in surrounding bone (porcine bone)
- . Lot-to-lot endotoxin testing is also performed per USP
Substantial Equivalence
The Fiji Anchor is as safe and effective as the Arthrex's Bio-PushLock. The Fiji Anchor has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Fiji Anchor and its predicate devices, summarized in the table below, raise no new issues of safety or effectiveness. Performance data demonstrate that the Fiji Anchor is as safe and effective as Arthrex's Bio-PushLock. Thus, the Fiji Anchor is substantially equivalent.
| Property | SportWelding Fiji | Arthrex 2.5 mm Bio- | Stryker Sonic Anchor |
|---|---|---|---|
| Anchor | PushLock | ||
| 510(k) | Subject | K063497 | K143063 |
| Components | Anchor, suture, | PEEK eyelet, suture, | Anchor, suture, |
| sonotrode, US generator | anchor | sonotrode, US generator | |
| Size | 2.3 x 7.2 mm | 2.5 x 8 mm | 2.5 x 12 mm |
| Suture Sizes | #4-0, #3-0, #2-0, #0, #2 | #2-0, #0 | #2-0, #0, #2 |
| Insertion Method | Insert anchor into | ||
| predrilled hole while | |||
| applying US energy | Insert eyelet into | ||
| predrilled hole, then | |||
| secure with | |||
| bioresorbable anchor | Partially insert anchor | ||
| into predrilled hole, then | |||
| fully insert while | |||
| applying US energy | |||
| Fixation Method | Ultrasonic melting of the | ||
| polymer into the porous | |||
| cancellous bone | Barbs in a mechanical | ||
| press-fit | Ultrasonic melting of the | ||
| polymer into the porous | |||
| cancellous bone | |||
| Length of | |||
| ultrasound | |||
| energy delivery | Not more than 6 | ||
| seconds | N/A | Not more than 12 | |
| seconds | |||
| Suture fixation | Manual knotting | Knotless | Manual knotting |
| Material | PLDLLA | PLLA and PEEK | PLDLLA |
| Resorbable | Yes | Partly | Yes |
| Sterilization | Sterile | Sterile | Sterile |
Conclusions
The Fiji Anchor is substantially equivalent to the predicate device.