(91 days)
The TranSet™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet™ Fracture Fixation System.
The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.
The TranSet™ Fracture Fixation System intended use is in the stabilization and linear fixation of bone or tissue fragments in orthopedic fractures and in ligament and tendon repair and reconstruction. The system consists of both absorbable and titanium cylindrical buttons manufactured from poly-L-lactic acid or titanium alloy. The buttons are provided sterile packaged with or without braided suture and are intended for single-patient use. Buttons are applied to the outer bone cortex and with suture running across the fracture site allows for stabilization and linear fixation of the bone or tissue fragments. This allows the bone or tissue fragments to be compressed and held together to promote healing. The cylindrical design of the buttons also allows them to be used as fixation devices in orthopedic ligament and tendon repair and reconstruction. The buttons are placed outside the cortical bone or though a soft tissue repair site and act as fixation posts by distributing suture tension over larger areas to promote healing and eliminate any suture tearing or pulling through the tissue. The absorbable buttons degrade over time and eliminate the need for any surgical removal. Removal of the titanium buttons is based upon surgeon preference. Reusable manual surgical instrumentation for insertion of the buttons and a sterilization tray for autoclaving complete the system.
This document, a 510(k) summary for the TranSet™ Fracture Fixation System, focuses on demonstrating substantial equivalence to predicate devices based on intended use and material similarity, as well as mechanical strength testing. It does not contain information typically found in a study proving a device meets specific acceptance criteria related to clinical performance or algorithm-driven accuracy.
Therefore, many of the requested categories cannot be filled from the provided text.
Here is the information that can be extracted or reasonably inferred, along with notations for what is not present:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength and Failure Modes: Demonstrate that the TranSet™ Fracture Fixation System's absorbable and titanium buttons are statistically equivalent in mechanical strength and failure modes to stainless steel Steinmann Pins (a commonly used fracture fixation procedure). This is inferred as the core performance comparison to establish substantial equivalence. | Statistically Equivalent: "Performance testing comparing the mechanical strengths and failure modes of the TranSet™ Fracture Fixation System absorbable and titanium buttons to stainless steel Steinmann Pins commonly used in fracture fixation procedures demonstrated the buttons are statistically equivalent." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical performance testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is physical performance testing, not clinical data from patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was mechanical performance testing, not a clinical study involving expert assessment of patient outcomes or images. The "ground truth" would be the measured physical properties of the materials.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This was mechanical performance testing, not a clinical study requiring human adjudication of results.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This document describes a medical device (fracture fixation system), not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Measured Physical Properties: The "ground truth" for the performance testing would be the objectively measured mechanical properties (e.g., tensile strength, bending strength, failure load) of the devices under controlled laboratory conditions.
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The sample size for the training set:
- Not Applicable. This is not an AI or machine learning study, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 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.