(60 days)
No
The document describes a mechanical/ultrasonic device for tissue fixation and does not mention any AI or ML components or functions.
Yes
The device is described as "fully bioresorbable implants designed for soft tissue reattachment to bone by means of suture materials," which is a therapeutic function aimed at treating injuries.
No.
The device is an implantable anchor system used for tissue fixation and reattachment to bone; it is a surgical tool, not a diagnostic device.
No
The device description clearly outlines multiple hardware components including implantable anchors, an ultrasonic system, a sonotrode, drills, stoppers, a handpiece, and a guide. The software mentioned in the performance studies is likely for controlling the ultrasonic generator or other hardware aspects, not the primary function of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "suture or tissue fixation in the foot, ankle, hand, wrist, elbow, knee, hip and shoulder." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details an "implantable anchor" made of bioresorbable material, an ultrasonic system for insertion, and associated tools. This aligns with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. The device's function is purely mechanical fixation.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, hip, knee and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser Generator.
SF Push-in Anchor 1.6mm:
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
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair
SF Push-in Anchor 2.3mm:
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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral epicondylitis repair
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Acetabular labral repair, capsular repair
SF Push-in Anchor 3.0mm and 3.6mm:
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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valqus and Varus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectorny
Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis
Hip: Acetabular labral repair, capsular repair
Product codes
MAI, HTY, GAT
Device Description
The SF Push-in Anchor system consists of implantable anchors with 1.6, 2.3, 3.0, and 3.6mm diameter, an ultrasonic system, a sonotrode, dedicated anchor size specific drills and stoppers, a handpiece front cover, and a guide with integrated wrench.
The SF Push-in Anchors are made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,L-lactide. The SF Push-in Anchors are fully bioresorbable implants designed for soft tissue reattachment to bone by means of suture materials. The implantation process employs ultrasonic energy to liquefy the polymeric components of the Push-in Anchors 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 Push-in Anchors is produced by the SupraFuser® ultrasonic generator and applied via the attached handpiece. The sonotrode is mounted on the handpiece. It transmits the ultrasonic vibrations to the Push-in Anchor. The drills and the stoppers are dedicated to be used with the Push-in Anchor of the respective size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, hand, wrist, elbow, hip, knee, 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
- Insertion testing
- Degradation testing
- Biocompatibility risk assessment
- Lot-to-lot endotoxin testing is also performed per USP
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Surgical Fusion Technologies GmbH % Kelliann Payne Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K240288
Trade/Device Name: SF Push- in 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: January 31, 2024 Received: February 1, 2024
Dear Kelliann Payne:
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.
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"
1
(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 OS 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.
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 mediation-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).
Image /page/1/Picture/7 description: The image shows a closing statement followed by a name. The closing statement is "Sincerely,". The name below the closing statement is "Maziar Shah Mohammadi". The text is left-aligned and uses a serif font.
gitally signed by Maziar Shal Date: 2024.04.01 10:52:53 -04'00
For: Jesse Muir, Ph.D. 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
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
SF Push- in Anchor
Indications for Use (Describe)
The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, hip, knee and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser Generator.
SF Push-in Anchor 1.6mm:
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
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair
SF Push-in Anchor 2.3mm:
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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral epicondylitis repair
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Acetabular labral repair, capsular repair
SF Push-in Anchor 3.0mm and 3.6mm:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and
4
MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectomy Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis Hip: Acetabular labral repair, capsular repair 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)
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5
Surgical Fusion Technologies GmbH's SF-Push-in Anchors
510(k) Summary
Surgical Technology's SF Push-in Anchor Portfolio
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Surgical Fusion Technologies GmbH Wagistrasse 6 Schlieren, Switzerland
Phone: +41 44 204 60 18 Facsimile: +41 44 204 61 2820 Contact Person: Joerg Mayer, CTO Date Prepared: March 29, 2024
Name of Device and Name
SF Push-in 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
- K171228 SportWelding's Fiji Anchor (Primary Predicate)
- K063479 Arthrex's Bio-PushLock (Secondary Predicate)
- K082810 Arthrex's Bio Composite Pushlock (Secondary Predicate)
- K183091 SpineWelding's Elaris Pedicle Screw System (Reference Device) .
Indications for Use
The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, knee, hip and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser Generator.
6
SF Push-in Anchor 1.6mm:
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 ioints for all digits, digital tendon transfers
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valqus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair
SF Push-in Anchor 2.3mm:
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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral epicondylitis repair
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valqus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Acetabular labral repair, capsular repair
SF Push-in Anchor 3.0mm and 3.6mm:
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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
7
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus and Varus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectorny
Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis
Hip: Acetabular labral repair, capsular repair
Technological Characteristics
The SF Push-in Anchor system consists of implantable anchors with 1.6, 2.3, 3.0, and 3.6mm diameter, an ultrasonic system, a sonotrode, dedicated anchor size specific drills and stoppers, a handpiece front cover, and a guide with integrated wrench.
The SF Push-in Anchors are made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,L-lactide. The SF Push-in Anchors are fully bioresorbable implants designed for soft tissue reattachment to bone by means of suture materials. The implantation process employs ultrasonic energy to liquefy the polymeric components of the Push-in Anchors 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 Push-in Anchors is produced by the SupraFuser® ultrasonic generator and applied via the attached handpiece. The sonotrode is mounted on the handpiece. It transmits the ultrasonic vibrations to the Push-in Anchor. The drills and the stoppers are dedicated to be used with the Push-in Anchor of the respective size.
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
- Insertion testing
- . Degradation testing
- Biocompatibility risk assessment .
- Lot-to-lot endotoxin testing is also performed per USP ●
8
Substantial Equivalence
The SF Push-in Anchors are as safe and effective as the primary predicate device by the same manufacturer (Fiji Anchors). The SF Push-in Anchors have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices (Arthrex's 2.5mm Bio PushLock, Bio-Composite PushLock). The minor technological differences between the SF Push-in Anchors and its predicate devices, summarized in the table below, raise no new issues of safety or effectiveness. Performance data demonstrate that the SF Push-in Anchors are as safe and effective as the Fiji Anchor as well as Arthrex's 2.5mm Bio PushLock or Bio-Composite PushLock. Thus, the SF Push-in Anchors are substantially equivalent. The reference device is cited to support testing methods and results.
| Property | SF Push- in Anchor | SportWelding Fiji
Anchor/SF Push-in anchor
2.3 | Arthrex 2.5 mm Bio-
PushLock | Arthrex Bio-Composite
PushLock |
|------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Predicate | Subject | Primary Predicate | Secondary Predicate | Secondary Predicate |
| 510(k) | Subject | K171228 | K063497 | K082810 |
| Components | Anchor, suture, Sonotrode,
US generator | Anchor, suture, sonotrode,
US generator | PEEK eyelet, suture, anchor | PEEK eyelet, suture, anchor |
| Size | 1.6mm/5.2mm
2.3mm/7.2mm
3.0mm/8.7mm
3.6mm/10.2mm | 2.3 x 7.2 mm | 2.5 x 8 mm | Diameter: 2.4-6.5mm/
Length: 5-18.5mm |
| Suture Sizes | 1.6mm: #4-0 to #0
2.3mm: #4-0 to #2
3.0mm: #0 to #2, tape up to
size 2mm
3.6mm: #2, tape up to size
2mm | #4-0 to #2 | #2-0. #0 | #2-0. #0, #2,tape up to size
2mm |
| Insertion Method | Insert anchor into predrilled
hole while applying US
energy | Insert anchor into predrilled
hole while applying US
energy | Insert eyelet into predrilled
hole, then secure with
bioresorbable anchor | Insert eyelet into predrilled
hole, then secure with
bioresorbable anchor |
9
| Property | SF Push- in Anchor | SportWelding Fiji
Anchor/SF Push-in anchor
2.3 | Arthrex 2.5 mm Bio-
PushLock | Arthrex Bio-Composite
PushLock |
|--------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------|-------------------------------------|
| Fixation Method | Ultrasonic melting of the
polymer into the porous
cancellous bone | Ultrasonic melting of the
polymer into the porous
cancellous bone | Barbs in a mechanical press-
fit | Barbs in a mechanical press-
fit |
| Length of
ultrasound energy
delivery | Not more than 6 seconds | Not more than 6 seconds | N/A | N/A |
| Suture fixation | Manual knotting | Manual knotting | Knotless | Knotless |
| Material | PLDLLA | PLDLLA | PLLA and PEEK | PLLA, PLDLA/TCP, PEEK |
| Resorbable | Yes | Yes | Partly | Partly |
| Sterilization | Sterile | Sterile | Sterile | Sterile |
Conclusions
The SF Push-in Anchors are substantially equivalent to the predicate devices.