(118 days)
Indications for Use: The Tigon Medical Button System implants are intended to facilitate fixation of bone or soft tissue to bone. Shoulder: Proximal Biceps Tendon Repair Minor Pectoralis Repair Major Pectoralis Repair Elbow: Distal Biceps Tendon Repair Ulnar Collateral Ligament Reconstruction Knee: Anterior Cruciate Ligament Repair Posterior Cruciate Ligament Repair
The Tigon Medical Button System is comprised of reusable instrumentation and button implants designed to interface together in order to secure soft tissue to bone and fixate bone to bone. The reusable instrumentation is designed to operate with any grouping of available buttons within the system. Each button is made of fitanium and designed to be used with #2 suture cable or 1.4 mm to 2 mm sufure tapes. Each button is made up of very similar eyelet geometry and a thickness of 2 mm. The button widths vary from 2.25 mm to 2.7 mm. The lengths of the buttons vary from 6.65 mm to 8 mm. The buttons are designed to function against a single cortex by resting in the intramedullary cavity or against the cortex on the opposite side of the fixation site.
The Tigon Medical Button System is compared to the Arthrex Biceps Button for demonstrating substantial equivalence. The following criteria and results were reported:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate: Arthrex Biceps Button) | Reported Device Performance (Tigon Medical Button System) |
|---|---|---|
| Product Codes | MBI | MBI |
| Indications | Same as Predicate (fixation of bone to bone or soft tissue to bone, specifically for shoulder, elbow, and knee repairs) | Facilitate fixation of bone to bone or soft tissue to bone for the same indications as the predicate. |
| Button - Sizes | Variety of different button combinations and sizes | Range of button sizes; widths vary from 2.25 mm to 2.7 mm, lengths from 6.65 mm to 8 mm. |
| Button - Mechanical Strength | Average mechanical pull out strength of 283.15N | Average mechanical pull out strength of 289.55N |
| Fatigue Testing | Up to 4000 cycles from 5N to 225N condition until failure; average failure at 855 cycles | Up to 4000 cycles from 5N to 225N condition until failure; average failure occurred at 909 cycles. |
| Button - Material | Ti-6Al-4V ELI Titanium per ASTM F-136 | Ti-6Al-4V ELI Titanium per ASTM F-136 |
| Button - Method of Fixation | Unicortical and bicortical | Unicortical and bicortical |
| Inserter | Multi-piece (2) disposable inserter; button loaded onto inserter in packaging prior to surgery | Multi-piece (3) reusable inserter; button loaded onto inserter during surgery. (Claimed as substantially equivalent due to functional similarity despite differences in reusability/loading). |
| Drills | 3.2 mm drill (Biceps Button), 4 mm drill pin (Retro Button) | (2.6mm - 3.2 mm) Drill bits for biceps. Drill appropriate sized holes to ensure proper button insertion. |
| Cannulas | Drill Guide | Drill Guide |
| Supplied | Buttons and instruments shipped sterile. | Buttons and instruments shipped sterile and non-sterile. (Claimed as substantially equivalent, citing other non-sterile titanium devices cleared for steam sterilization). |
2. Sample size used for the test set and the data provenance
The document indicates that "Mechanical testing has been done, including cyclical loading and tensile strength," but does not explicitly state the sample sizes (number of devices tested) for the pull-out strength or fatigue testing. The data provenance is not mentioned, but it can be inferred that these were laboratory-based non-clinical tests rather than human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study involved non-clinical mechanical testing, not a medical imaging or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
This information is not applicable as the study involved non-clinical mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The study focused on mechanical performance comparison of the device itself, not on human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done as this is a mechanical fixation device, not a software or AI product.
7. The type of ground truth used
For mechanical strength and fatigue testing, the "ground truth" was established by measured physical properties (e.g., maximum pullout strength in Newtons, number of cycles to failure) observed under controlled laboratory conditions, compared against the reported performance of a legally marketed predicate device.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set."
§ 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.