Search Results

The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
Elbow: Tennis elbow repair
Knee: Medial and lateral collateral ligament repair.
Wrist: Scapholunate ligament reconstruction

The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

Shoulder: Rotator Cuff Repair, Biceps Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis

The DueLock™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The DueLock™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

Shoulder: Rotator Cuff Repair, Bankart Repair, Capsular Shift and Capsulolabral Reconstruction, Subscapularis Tendon Tears

Elbow: Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Metatarsal Tendon Repair.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
Hip: Acetabular labral repair.

The VersaTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

The MiniTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MiniTTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixsue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:

Elbow: Ulnar/Medial Collateral Ligament Repair

Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.

Device Description

The VersaTap™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. This anchor is ingeniously designed to combine the advantage of both PEEK and Titanium. The titanium tip allows for self-tapping ability whilst the majority of the anchor is manufactured from PEEK which minimizes post-operative imaging effects.

The VersaLat™ Suture Anchor is an innovative knotless-/suture anchor inspired by a top orthopedic shoulder surgeon. This PEEK screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differs this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments

The DueLock™ Suture Anchor is a flexible anchor that combines the functional push-in anchors into one multi-purpose suture anchor can be used as a knotless suture anchor as well as a push-in, preloaded suture anchor used in both small and large-joint repairs.

The VersaTi™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. The anchor is designed for ultimate mechanical properties (pull-out strength, etc.) and ease of use. VersaTi™ Suture Anchor is recommended for use in small and large-joint repairs without the need for tapping or drilling.

The MiniT™ Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.

AI/ML Overview

This document describes the acceptance criteria and study data for several Suture Anchors (VersaTap™, VersaLat™, DueLock™, VersaTi™, and MiniTi™). The device's performance is demonstrated through non-clinical testing to show substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by demonstrating "similar or improved" performance compared to predicate devices or established literature, and by meeting regulatory requirements.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Meet or exceed performance of predicate devices in static pull-out, insertion torque, fatigue, and corrosion testing, as per FDA Guidance Document: Bone Anchors—Premarket Notification (510(k)) Submissions.	All devices (VersaTap, VersaLat, DueLock, VersaTi, MiniTi) demonstrated "similar or improved pull out force compared to the primary predicate" and met requirements for insertion torque, fatigue, and corrosion. (Direct comparison data is not provided in this summary, but the conclusion states equivalence). The VersaTap™ is designed to combine the advantage of both PEEK and Titanium. The titanium tip allows for self-tapping ability whilst the majority of the anchor is manufactured from PEEK which minimizes post-operative imaging effects. The VersaTi™ had its thread designed for optimal pull-out strength and mechanical stability, and thread design for cancellous and cortical fixation while the MiniTi™'s specially engineered thread combines with cortical bone to provide tremendous pull-out strength.
Biocompatibility	Compatibility with human tissues, as demonstrated by materials previously cleared by FDA for reference devices and manufacturing processes conforming to ISO 9001/ISO 13485.	For all devices, the materials, processes, and cleaning agents used have been previously cleared by the FDA for reference devices manufactured by the same facility (Elite Surgical Supplies) under an OEM agreement with Ortho-Design, conforming to ISO 9001 (and ISO 13485 for DueLock™).
Sterility	Achieve a Sterility Assurance Level (SAL) of 10^-6.	The Overkill Method was successfully conducted to achieve a SAL of 10^-6, based on IQ, OQ, and PQ results and identified parameters and tolerances.
Shelf-Life	Maintain mechanical and functional integrity for a specified shelf-life (3 years).	All devices have a validated shelf-life of 3 years using accelerated aging techniques. Real-time aging is ongoing. Implant components are made from PEEK OPTIMA (ASTM F2026) and Titanium Alloy (ASTM F136), which are historically used in implants and not mechanically affected by aging within 3 years.
Packaging	Ensure sterility and safe transfer to operative field, including appropriate labeling.	All devices are boxed individually in EtO sterilized double peel pouches (60g/m² medical plastic film and paper) for sterile transfer. Each package includes external labeling, an instruction leaflet, and individual patient labels. Instruments are provided separately in non-sterile trays.
Endotoxin/Pyrogenicity	Non-pyrogenic.	All devices were tested and found to be non-pyrogenic.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each mechanical test (static pull-out, insertion torque, fatigue, corrosion). It states that "This testing was done on the subject device and the primary predicate device" or "compared to the data found in literature". The data provenance is from non-clinical bench testing conducted by the manufacturer (Ortho-Design (Pty) Ltd in South Africa or their OEM, Elite Surgical Supplies). The comparison data for predicates sometimes comes from literature, implying retrospective use of published data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a submission for medical devices that are primarily evaluated based on non-clinical (mechanical, material, sterilization) testing, not on diagnostic accuracy requiring expert interpretation of results or images. The "ground truth" for mechanical properties is established by standardized testing methods.

4. Adjudication Method for the Test Set

Not applicable, as this is related to human interpretation or diagnostic accuracy studies, which are not detailed in this submission. The "adjudication" for mechanical testing is based on objective measurements and comparison against established standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (MRMC) is typically performed for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The submitted device is a physical medical implant (suture anchor).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The devices are physical implants, not algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims (e.g., pull-out strength, biocompatibility, sterility) is based on objective measurement results from standardized non-clinical tests (mechanical testing, chemical analysis for biocompatibility, sterility validation methods) and comparison to established regulatory standards and predicate device data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The term "training set" is typically used in the context of machine learning model development.

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI/ML device, there is no training set for which to establish ground truth.

Ask a Question

Ask a specific question about this device

Page 1 of 1