CE Certification Calcaneal Locking Plate Company & Clinical Solutions

Variable-angle (VA) locking mechanics permit up to ±15° of off-axis screw angulation around the central axis of each hole. In calcaneal fracture repair, anatomical fracture lines are highly variable. Fixed-angle monoaxial plates force screws down rigid, predetermined paths that often cross fracture lines or fail to capture the dense, non-comminuted bone of the sustentaculum tali. The ZATH VA system allows the surgeon to manually direct screws directly under the depressed subchondral articular facet and anchor securely into solid bone fragments, creating a customized internal scaffold that resists vertical shear loads.

The subcutaneous lateral wall of the calcaneus has minimal muscular padding and relies heavily on microvascular cutaneous perfusion supplied by the lateral calcaneal artery. Bulky plates exceeding 2.0 mm thickness create substantial soft-tissue tension upon wound closure, frequently triggering incision edge ischemia, full-thickness necrosis, wound breakdown, or chronic peroneal tendon tenosynovitis. ZATH's calcaneal locking plate features an ultra-low profile (1.35 mm–1.45 mm), smoothly tapered edges, and fully countersunk screw heads that sit flush with the plate surface, radically reducing dead space and pressure-induced devitalization.

Every shipment to hospital or distributor partners is accompanied by a complete Technical Regulatory Packet. This includes the Declaration of Conformity under ISO 13485:2016 and CE medical device standards, raw material metallurgical analysis certificates (showing compliance with ASTM F136 / ISO 5832-3), EO or gamma sterilization validation certificates conforming to ISO 11135 / ISO 11137, biocompatibility assessment summaries under ISO 10993, and lot-specific release testing logs guaranteeing dimensional conformance and mechanical integrity.

Yes. While suitable for standard extended lateral approaches, the plate geometry has been specifically streamlined for minimally invasive Sinus Tarsi incisions. The tapered anterior and posterior ends allow the plate to be inserted sub-periosteally through a 3–5 cm oblique incision stretching from the tip of the fibula toward the base of the fourth metatarsal. Screw placement can then be performed either directly through the wound or via percutaneous stab incisions under fluoroscopic guidance, minimizing disruption of the lateral hematoma and periosteal blood supply.

The dedicated ZATH calcaneal system is delivered in an anodized, dual-tier autoclavable instrument case. Key instruments include: threaded variable-angle drill sleeves, standard perpendicular drill guides, calibrated depth gauges with blunt probing tips, self-retaining star/hexalobe screwdrivers with torque-limiting adapters, sharp calcaneal reduction hooks, Schanz pins and universal T-handles for tuber manipulation, periosteal elevators, and specialized Hohmann retractors designed for hindfoot exposure.

Standard catalog items under the ZATH brand have no restrictive minimum order quantities for authorized distribution partners and are dispatched from our Beijing logistics facility within 48 to 72 hours via express air freight (4–6 days delivery). For custom OEM/ODM projects (custom laser marking, specific hole spacing, custom anodized colors, or proprietary blister packaging), production cycles typically run between 3 to 5 weeks from technical drawing sign-off, with initial pilot batches starting as low as 50 to 100 units per specification.

Titanium-on-titanium galling or cold-welding can occur when matching titanium screws are driven into locking plate holes with excessive torque, complicating future hardware removal. ZATH resolves this by applying a specialized Type II medical-grade electrochemical surface treatment to the plate combined with precise thread-pitch engineering. This controlled oxide boundary alters the micro-hardness differential between the screw head threads and the plate eyelet, preventing galling during insertion while guaranteeing secure, cross-thread-resistant locking.

Yes. Manufactured entirely from high-purity medical titanium and Ti-6Al-4V ELI alloys, our implants are non-ferromagnetic (magnetic susceptibility is negligible). In accordance with ASTM F2503 guidelines, patients fixed with ZATH titanium implants can undergo diagnostic Magnetic Resonance Imaging (MRI) scans safely under standard clinical 1.5-Tesla and 3.0-Tesla settings with minimal radiofrequency-induced heating and negligible imaging artifacts compared to traditional stainless steel implants.