Explore our ready-to-ship and custom OEM anatomical clavicle locking plate systems, available in medical-grade Titanium (Ti-6Al-4V ELI) and Stainless Steel (316L) with complete 113-piece instrument sets.
Founded in 1987, Siora Surgicals Pvt. Ltd. operates a state-of-the-art medical device manufacturing campus spanning advanced CNC/VMC machining units in the RAI Industrial Estate, Sonipat, Haryana. As a leading manufacturer and exporter of orthopedic implants, we empower global distributors and OEM partners in 50+ countries with world-class trauma systems.
Our clavicle locking plate systems are produced under strict ISO 13485:2016 quality management standards, holding CE compliance, Malaysian MDA approvals, and Indian FDA Free Sale Certificates. We specialize in turn-key OEM/ODM contract manufacturing, custom implant engineering, and private label packaging produced within ISO Class 10,000 cleanroom facilities.
An authoritative analysis of anatomical precontouring, angular stability, material mechanics, and stress distribution in midshaft and distal clavicle osteosynthesis.
The human clavicle exhibits a complex double-curve geometry—convex anteriorly in its medial two-thirds and concave anteriorly in its lateral third. Siora’s precontoured S-clavicle plates are digitally mapped from multi-ethnic 3D CT datasets, reducing the need for intraoperative plate bending by over 85% and maintaining structural fatigue limits.
Featuring threaded combi-holes, our locking systems act as fixed-angle constructs. This creates a rigid construct that transfers stress across the fracture line rather than relying on bone-to-plate friction, dramatically preventing secondary loss of reduction, screw toggle, and thermal osteonecrosis in osteoporotic bone.
Manufactured from Premium Titanium Alloy (Ti-6Al-4V ELI per ASTM F136) and Implant-Grade 316L Stainless Steel (ASTM F138). Titanium implants present a lower modulus of elasticity close to human cortical bone, reducing stress shielding while fostering rapid callus development and soft tissue acceptance.
| Implant Parameter | Titanium Alloy (Ti-6Al-4V ELI) | Stainless Steel (316L) | Clinical Advantage |
|---|---|---|---|
| Tensile Strength (MPa) | ≥ 860 MPa | ≥ 690 MPa | Resists cyclic torsional loading during arm elevation |
| Modulus of Elasticity (GPa) | 110 GPa | 200 GPa | Titanium closer to bone (18-30 GPa); minimizes stress shielding |
| Plate Profiles Available | Superior, Superior-Anterior, Distal Star | Superior S-Shape, Anterior-Inferior | Matches patient-specific clavicular cross-sections |
| Screw Compatibility | 2.7mm & 3.5mm Locking / Cortex Screws | 3.5mm Locking & Cortex Screws | Allows hybrid fixation (compression + fixed-angle locking) |
| Biocompatibility / MRI | Non-magnetic, minimal MRI artifact | Standard surgical artifact profile | Clear postoperative diagnostic imaging with Titanium |
| Sterilization Packaging | Gamma Sterilized / Non-Sterile Trays | EO / Autoclave Ready / Cleanroom Sealed | ISO Class 10,000 cleanroom packaging compliance |
In midshaft clavicle fracture management (AO/OTA 15-B), finite element analysis (FEA) demonstrates that superior placement provides significantly higher bending rigidity under inferiorly directed loads. However, superior plating poses a higher risk of prominence and subclavian neurovascular compromise during drilling. Siora’s dual-option OEM portfolio offers ultra-low-profile Superior-Anterior plates with divergent 2.7mm distal screw trajectories, reducing hardware prominence by 42% while preserving bicortical pull-out strength.
Request Technical FEA Reports & DrawingsWe partner with international medical device brands, regional importers, and healthcare networks to deliver customized orthopedic implants under strict non-disclosure and quality guarantees.
Establish your brand presence in regional trauma markets. We supply high-precision laser marking for logos, lot numbers, GS1 DataMatrix barcodes, and customized sterile/non-sterile box packaging according to regulatory guidelines.
Our R&D team works directly from your 3D STEP/IGES models or physical prototypes. Utilizing multi-axis VMC machinery, we prototype and mass-produce bespoke bone plate geometries tailored to specialized surgical preferences.
Accelerate your product registration. We supply comprehensive technical dossiers, raw material mill certificates, bio-compatibility reports, cleaning validation, and ISO 13485 audit support for global health authorities.
Eliminate supply chain disruptions. Siora maintains safety stock across our 2,000+ trauma SKUs, enabling rapid dispatch of complete clavicle locking plate systems, dedicated instruments, and replacement screws within tight timelines.
Emerging technologies, surgical shifts, and strategic sourcing dynamics reshaping the global shoulder girdle reconstruction landscape.
Siora Surgicals maintains an established global export footprint, providing seamless logistics, customs compliance assistance, and dedicated account support for international distributors, tenders, and hospital chains.
Whether you require localized labeling, specific screw thread profiles, or custom kit tray layouts, our experienced international logistics team ensures punctual air and sea freight delivery backed by international packaging compliance.
Get fast, accurate technical and business answers regarding OEM ordering, material certification, sterilization, and custom kit configurations.
Superior clavicle plates sit on the dorsal anatomical surface of the bone, offering superior biomechanical resistance against vertical bending forces. Superior-Anterior plates are contoured to wrap around the anterior margin, reducing soft-tissue protrusion and hardware irritation while providing stable divergent screw trajectories into the thicker anterior cortical wall.
We manufacture clavicle plates and screws in two distinct material lines: Medical Grade Titanium Alloy (Ti-6Al-4V ELI conforming to ASTM F136 / ISO 5832-3) and High-Strength Stainless Steel (316L conforming to ASTM F138 / ISO 5832-1). Both offer exceptional bio-inertness, fatigue resistance, and micro-finish surface treatments.
Yes. We provide complete OEM/ODM services including custom logo laser-etching on plates and instruments, customized graphic sterilization trays (113-piece sets), customized outer box packaging, and multi-lingual instruction manuals adhering to your target market's medical device labeling rules.
Our manufacturing plant operates under an ISO 13485:2016 certified Quality Management System. Our trauma products carry CE certification, Malaysian MDA approvals, and Indian FDA Free Sale Certificates. We supply full technical files, raw material mill test reports, sterilization validation reports, and bio-compatibility data to assist with local healthcare authority registration.
Implants can be supplied as non-sterile items packaged in protective medical-grade poly-pouches ready for hospital autoclaving, or pre-sterilized in ISO Class 10,000 cleanroom facilities using validated Gamma Irradiation or Ethylene Oxide (EO) double-peel pouch systems with a 5-year shelf-life stability.
Standard catalog items from our ready stock carry low MOQs for authorized distributors. For customized OEM plate geometries or custom-branded 113-piece sets, typical production lead times range between 3 to 6 weeks depending on design complexity, anodization requirements, and batch sizes.
Siora's S-Clavicle locking combi-holes are engineered to accept 3.5mm cortex screws for compression and 3.5mm locking screws for fixed-angle stability. Selected low-profile anterior and distal star plates also incorporate 2.7mm locking screws to maximize point fixation in osteopenic distal bone fragments.
We supply evaluation sample packs and non-sterile demonstration sets for engineering review, dimensional verification, and surgical fitting assessment. Contact our export team directly using the live chat or inquiry buttons to request an evaluation kit.
Partner with Siora Surgicals Pvt. Ltd. for reliable manufacturing, competitive OEM factory pricing, and global delivery of CE & ISO 13485 certified clavicle locking plates.