Search Results

The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended for femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts.

The RigidFix Biocryl Femoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).

The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autografi or allograft ACL soft tissue grafts (semitendinosus and gracillis).

The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/85%PLA) material. The proposed RigidFix Biocryl 2.7 mm BTB Cross Pins are used for the fixation of bone-tendon-bone grafts to the femur and the tibia in Anterior Cruciate Ligament (ACL) reconstruction. A total of four RigidFix Biocryl 2.7 mm BTB Cross Pins are used to complete the reconstruction: two on the femur and two on the tibia.

The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/85%PLA) material. The proposed RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Femoral 3.3 mm ST Cross Pins are used to complete the repair.

The proposed RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are absorbable implants manufactured from "Biocryl" (15% ß-TCP/85%PLA) material. The proposed RigidFix biocryl Tibial 3.3 mm ST Cross Pins are used for the fixation of soft tissue (semitendinosus and gracillis) grafts to the femur in ACL reconstruction. Two RigidFix Biocryl Tibial 3.3 mm ST Cross Pins are used to complete the repair.

Each RigidFix Biocryl Cross Pin Kit is provided sterile and is for single patient use only.

Except for the Interlocking Trocar and Sleeve assemblies that are packaged in the RigidFix kits with the RigidFix Biocryl pins, other reusable instrumentation is offered separately to assist in the placement of the RigidFix Biocryl pins. The instrumentation consists of Tibial Guide Frame, Tibial Rods, Long Stepped Trocar, Trocar Trial. Guide Block Head Thumb Screw, Probe, Short Stepped Trocar, Tibial Pin Insertion Rod and Femora/Tibial Rod Thumb Screw. These devices are all stainless steel, non-sterile, reusable devices.

This 510(k) summary for the RigidFix Biocryl Cross Pin Kit describes a medical device, specifically absorbable implants for ACL reconstruction. However, it does not contain the specific information required to complete the requested table and answer the study-related questions.

Here's why and what information is present:

What is present in the document:

• Device Description: The document describes the RigidFix Biocryl Cross Pins as absorbable implants made from "Biocryl" (15% ß-TCP/85%PLA). It specifies their use for femoral and tibial fixation of bone-tendon-bone or soft tissue grafts in ACL reconstruction.
• Indications for Use: Clearly states the intended use for different versions of the cross pins (BTB and ST) for ACL reconstruction with autograft or allograft.
• Predicate Devices: Lists several predicate devices (e.g., RigidFix Cross Pin Kits, BioIntrafix Tibial Tapered Sheaths and Screws, Biocryl Interference Screws) to which the new device is claimed substantially equivalent.
• Safety and Performance Statement: Mentions "certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification." This is the closest mention of performance data, but it's a general statement, not a detailed report.

What is missing from the document (and therefore cannot be provided in the table/answers):
The document is a 510(k) summary, which generally provides an overview for substantial equivalence, not detailed study reports. It does not contain the specific technical performance data, acceptance criteria, or study design details that would be found in a full study report or the body of the 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions below because the necessary information is not provided in the given text.

Unable to Complete - Information Not Provided in the Document

The provided 510(k) summary for the RigidFix Biocryl Cross Pin Kit does not include the detailed information regarding acceptance criteria, specific device performance metrics, study design (sample sizes, data provenance, ground truth establishment, expert adjudication), or comparative effectiveness study results. The summary only generally states that "results of validation testing (performance testing) for the device modification" were provided in support of the 510(k).

To fully answer your request, a detailed performance testing report would be required.

Ask a specific question about this device