Bone Anchors

Knee Joint Femoral Component, used alongside bone anchors in orthopedic fixation, must meet stringent sterility and cleanliness requirements to avoid postoperative infection and comply with surgical asepsis standards. Manufactured under ISO 13485 environments, these components undergo validated double-sterilization cycles, ensuring bioburden elimination without material degradation. Controlled packaging processes preserve the sterile barrier for up to 5 years, addressing procurement demands for long shelf-life and reducing intraoperative contamination risk.

Material Specification

Titanium 6Al-4V ELI (ASTM F136), Stainless Steel 316LVM (ASTM F138)

Dimensional Tolerance

±0.05mm (Major/Minor Diameter), ±0.1mm (Length), Thread Pitch – ±0.02mm

Surface Finish

Ra ≤0.4µm (Thread Flanks), Ra ≤0.8µm (Body), Porous Coating – Ra 3.2–6.3µm

Concentricity/Runout

≤0.02mm TIR (Thread Axis), ≤0.05mm (Body Runout)

Thread Specifications

Self-Tapping (ISO 5835), M2–M6 (ISO 5835-1), Thread Pitch – ±0.01mm

Product Description

Implantation success relies heavily on the congruency of the Knee Joint Femoral Component with the patient’s anatomical femoral condyles. Precision-contoured sagittal and coronal profiles replicate native curvature to maintain consistent femorotibial contact during gait cycles. Advanced CAD/CAM modeling enables size variants that minimize overhang and undercoverage, solving intraoperative sizing mismatches and reducing post-surgical impingement complications. 

Heat Treatment

Solution Treated & Aged (Ti, ASTM F136), Annealed (SS, ASTM F138)

Surface Treatment

Hydroxyapatite (HA, ASTM F1185), Titanium Plasma Spray (ASTM F1580), Anodized (Ti, ASTM F86)

Certification Standard

ISO 13485, FDA 510(k), ASTM F543 (Bone Screws), ISO 10993-1 (Biocompatibility)

Tool Radius

Cutting Tool Radius – 0.1–0.3mm, Chamfer – 0.2mm x 45°, No Sharp Edges (ISO 14602)

Inspection Method

100% CMM (±0.01mm), Thread Gauge (Go/No-Go), Metallography (ASTM E3), Lot Sampling (AQL 1.0)

Technical Advantages

Every Knee Joint Femoral Component is supplied with full documentation aligned with EU MDR 2017/745, US FDA 21 CFR Part 820, and ISO 10993 biocompatibility standards. Each component includes UDI labelling and serialized data embedded in digital traceability systems for audit readiness. These traceability features enable full batch recall capability and compliance with national joint registries. 

Tight tolerance control in the manufacturing of the Knee Joint Femoral Component is critical for ensuring optimal articulation and prosthesis lifespan. CNC machining operations with multi-axis control achieve dimensional precision within ±10 microns on condylar radii and intercondylar box geometry. Each lot undergoes coordinate measuring machine (CMM) validation and wear simulation, ensuring reproducibility across procurement batches. 

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Industry Applications

Rotator Cuff Repair

Used to secure tendon to humeral head, maintaining soft-tissue tension during post-operative healing and cyclic shoulder motion. 

Anterior Cruciate Ligament (ACL) Reconstruction

Provides stable graft fixation within femoral or tibial tunnel to restore joint kinematics under physiological loading conditions. 

Spinal Fusion Constructs

Anchors provide sublaminar or lateral fixation for rod-screw constructs, enhancing segmental stability and reducing hardware migration risk. 

Foot and Ankle Ligament Repair

Used to reattach deltoid or lateral ligaments to bone, preserving ankle stability under multi-directional mechanical stress. 

Labral Reattachment in Hip Arthroscopy

Secures acetabular labrum to bony rim, restoring fluid seal and improving femoroacetabular articulation during flexion-extension movements. 

Elbow Ulnar Collateral Ligament (UCL) Repair

Facilitates reconstruction of medial elbow ligament complex, resisting valgus stress during repetitive throwing or overhead athletic activity. 

 

Bone Anchors

Load Transfer Efficiency Across Soft-Tissue Interfaces

Fixation failure is often caused by mismatch between anchor rigidity and soft tissue compliance. Bone anchors featuring dynamic eyelet articulation or suture groove micro-texturing promote even load transfer, minimizing stress concentrations. These features allow the construct to accommodate cyclic physiological motion without cutting through tendons or ligaments. Purchasers benefit from reduced revision rates and improved functional integration of soft tissue. 

Procurement for global healthcare networks demands alignment with multi-jurisdictional medical device standards. Frigate Bone Anchors meet MDR (EU 2017/745), US FDA CFR 21 Part 820, and ISO 13485:2016 certification requirements. Full lot-level traceability, including UDI labelling and digital batch documentation, ensures seamless audit-readiness for OEMs and hospital systems. 

 

Bone Anchors

Having Doubts? Our FAQ

Check all our Frequently Asked Question

How does Frigate ensure dimensional consistency in bone anchors thread geometry across production batches?

Frigate utilizes multi-axis CNC machining with real-time tool wear compensation to maintain thread accuracy within ±10 micron tolerance. Each lot is inspected using coordinate measuring machines (CMM) and validated against master CAD profiles. Thread pitch, depth, and helical angle are statistically monitored through process capability indices (Cp, Cpk). This ensures reproducibility of anchoring performance across diverse surgical indications. 

What fatigue testing protocols are used by Frigate to evaluate bone anchors performance under repetitive loading?

Frigate conducts high-cycle fatigue testing per ASTM F2077 and ISO 12189 using synthetic bone models with simulated tissue loading. Test rigs apply sinusoidal axial loads exceeding 10 million cycles to capture early microfailure onset. Stress amplitude and displacement are recorded to assess fatigue endurance limits. This validates long-term mechanical integrity for load-bearing tendon and ligament fixation. 

 

How does Frigate address imaging compatibility issues with metallic bone anchors in post-operative MRI evaluations

Frigate offers titanium anchors with optimized surface polishing to minimize eddy current-induced distortion in MRI fields. For artifact-sensitive cases, radiolucent PEEK anchors are manufactured using injection-compression molding to preserve internal geometry. All anchor materials are benchmarked using ASTM F2119 artifact testing protocols. This allows radiologists to evaluate periprosthetic healing with minimal interference. 

What suture integration methods does Frigate use to reduce soft-tissue cut-through in dynamic loading applications?

Frigate preloads anchors with ultra-high molecular weight polyethylene (UHMWPE) sutures that undergo plasma surface treatment for increased knot friction. Eyelets are precision-reamed and chamfered to prevent abrasion under high-tension cycles. Mechanical testing confirms suture retention strength and abrasion resistance under tendon simulation models. These features ensure durable fixation in high-mobility joints. 

How does Frigate validate bone anchor performance in osteoporotic bone models?

Frigate tests anchor prototypes in polyurethane foam blocks replicating osteoporotic trabecular density per ASTM F1839 standards. Pull-out and torque-to-failure values are measured against both baseline and augmented fixation scenarios. Finite element analysis (FEA) is also used to simulate stress distributions in osteoporotic regions. This comprehensive approach supports safe use in elderly or low-density bone conditions. 

 

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LOCATIONS

Global Sales Office

818, Preakness lane, Coppell, Texas, USA – 75019

Registered Office

10-A, First Floor, V.V Complex, Prakash Nagar, Thiruverumbur, Trichy-620013, Tamil Nadu, India.

Operations Office

9/1, Poonthottam Nagar, Ramanandha Nagar, Saravanampatti, Coimbatore-641035, Tamil Nadu, India. ㅤ

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Bone Anchors

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