(116 days)
RigidFix Biocryl Cross Pin Kits:
The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts.
The RigidFix Biocryl Fcmoral 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 autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
BioIntrafix Tibial Tapered Sheaths and Screws:
The BioIntrafix Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.
Biocryl Interference Screws:
The Biocryl Interference Screw is indicated for the fixation of soft tissue grafts gr bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
RigidFix Biocryl Cross Pin Kits:
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. In accordance to CFR §888.4540, these are Class I devices and, therefore, are exempt from 510(k) premarketing notification procedures. Validated cleaning and sterilization instructions are provided for those instruments.
BioIntrafix Tibial Tapered Sheaths and Screws:
The DePuy Mitek BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are absorbable implants made from a composite of absorbable Polylactic Acid (PLA) Polymer and Tricalcium Phosphate (TCP). They are used to secure soft tissue grafts to the bone during cruciate ligament reconstruction. The BioIntrafix Tibial Tapered Screws and BioIntrafix Tibial Sheaths are supplied sterile ready to use. The tie tensioner is a non-sterile, reusable instrument used to apply and measure tension on the graft.
Biocryl Interference Screws:
The DePuy Mitek Biocryl Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly Lactic Acid.(PLA) polymer and Tricalcium Phosphate (TCP). The Biocryl Interference Screw is packaged one per pouch.
This document describes a 510(k) premarket notification for several medical devices: RigidFix Biocryl Cross Pin Kits, BioIntrafix Tibial Tapered Sheaths and Screws, and Biocryl Interference Screws. The submission aims to establish substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Study Details:
Based on the provided text, there is no specific acceptance criteria table or a study described to demonstrate the device meets acceptance criteria in the traditional sense of a clinical or performance study with defined metrics.
Instead, the submission for these devices relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the primary "acceptance criterion" is that the new devices have the same indications for use and technological characteristics as their predicates, and therefore, do not introduce new questions of safety or effectiveness.
Here's a breakdown based on your requested information, acknowledging the nature of this 510(k) submission:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion (Implicit for Substantial Equivalence) Reported Device Performance Identical Indications for Use Met Identical Technological Characteristics (design, materials) Met Maintain Safety and Performance Inferred as met based on predicate device performance, as "additional safety and performance testing on the proposed products are not necessary." -
Sample Size Used for the Test Set and Data Provenance:
- No test set in a traditional sense was used for this 510(k) submission. The submission is based on a comparison to predicate devices, not new testing of the current devices for safety and performance in clinical or laboratory settings.
- The document mentions a "36-month stability study reviewed to support a 3-year shelf life claim," but does not provide details on its methodology, sample size, or results. This study is related to shelf-life, not clinical performance or safety.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No external experts were used to establish ground truth for a test set for this submission, as reported studies were not conducted on the devices themselves.
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Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication was used.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. No MRMC comparative effectiveness study was conducted or reported in this document.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. These are physical medical implants, not software algorithms, so a standalone algorithm study is not relevant.
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Type of Ground Truth Used:
- For the purpose of this 510(k) submission, the "ground truth" essentially refers to the established safety and effectiveness profiles of the predicate devices, which have already undergone regulatory clearance based on their own testing and real-world performance. There is no new ground truth established for the described devices through new studies.
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Sample Size for the Training Set:
- Not applicable. These are physical implants, not AI/ML models, so there is no "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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.