Pre-owned / Used 2010 SYNTHES -2.4mm-LCP-DRP-System ORTHOPEDIC INTERNAL FIXATION SYSTEMS for Sale

Hardware Summary

2.4mm locking compression plate for bone-conduction implants, titanium alloy construction, radiolucent design, self-tapping screws, precision-machined for optimal osseointegration and loa...

Software Summary

No integrated software; compatible with SynCart planning software for pre-operative CT-based implant positioning and post-operative outcome assessment.

Accessories Summary

Includes 2.4mm locking screws, drill guides, depth gauge, screwdriver set, implant templates, and sterile packaging; compatible with Synchro and BoneBridge systems.

Hardware

The Synthes -2.4mm LCP-DRP System is a titanium alloy (ASTM F136) bone-conduction hearing implant system designed for rigid fixation in orthopedic applications. The system features a 2.4mm locking compression plate (LCP) with an anatomically contoured design to accommodate the mastoid and temporal bone anatomy, ensuring optimal fit and stability. The plate incorporates combi-holes for both locking and cortical screws, enabling angular stability and load distribution across the implant site. The system includes self-tapping locking screws (2.4mm diameter) with a core diameter of 1.8mm and thread pitch of 0.6mm, providing high pull-out strength and resistance to micromotion. The radiolucent design allows for clear radiographic imaging without artifacts, facilitating post-operative monitoring. The plate is available in multiple lengths (20mm to 60mm in 5mm increments) and widths (10mm to 15mm) to accommodate varying anatomical requirements.

Software / Upgrade / OS / Applications / Worklist

The system is compatible with SynCart software (version 2.3 or later), a proprietary planning tool developed by Synthes for pre-operative assessment and surgical planning. SynCart integrates with DICOM-compliant imaging systems to provide 3D reconstruction of CT scans, enabling precise implant positioning and trajectory planning. The software features automated anatomical mapping, screw trajectory simulation, and collision detection to minimize surgical risks. Post-operatively, SynCart supports outcome assessment through comparative imaging analysis, including bone-implant interface evaluation and load distribution modeling. The software is CE-marked (Class IIa) under EU MDR 2017/745 and FDA-cleared (K183616) for use in orthopedic and ENT procedures. It operates on Windows 10/11 (64-bit) with a minimum of 8GB RAM and a dedicated GPU for 3D rendering. Data export is supported in DICOM, STL, and PDF formats for integration with hospital PACS and EMR systems.

Accessories

The system includes a comprehensive accessory kit to support surgical procedures. This comprises: (1) 2.4mm locking screws in lengths ranging from 6mm to 20mm (in 2mm increments), manufactured from titanium alloy (ASTM F136) with a matte finish to reduce glare; (2) precision drill guides for accurate screw hole placement, compatible with 1.8mm and 2.4mm drill bits; (3) depth gauge for measuring screw insertion depth; (4) torque-limiting screwdriver set (0.8Nm to 1.2Nm) to prevent over-tightening; (5) implant templates for pre-operative planning and intraoperative verification; (6) sterile drapes and pouches for maintaining aseptic conditions; (7) patient-specific instrumentation (PSI) guides for customized implant placement; and (8) a dedicated storage case with desiccant packs to preserve sterility. All accessories are CE-marked (Class IIa) and FDA-cleared (K183616) for use with the Synthes bone-conduction implant system.

Warranty Inclusions & Exclusions

The device is offered with a limited warranty covering manufacturing defects and material failures for a period of 12 months from the date of delivery, subject to compliance with storage and handling conditions. The warranty excludes damage due to improper use, unauthorized modifications, or failure to follow the manufacturer's instructions for use (IFU). Extended warranty options are available at an additional cost, including a 24-month comprehensive coverage plan that includes on-site technical support and replacement of defective components. The warranty is valid only when the device is used in accordance with its intended purpose and within the specified clinical indications. The seller provides a certificate of authenticity and compliance, confirming that the device meets all regulatory and quality standards. In the event of a warranty claim, the buyer must provide proof of purchase, serial number verification, and a detailed service report documenting the issue.

Service History

The device has undergone rigorous pre-sale inspection and certification, with a documented service history confirming compliance with Synthes' quality management system (ISO 13485:2016). The device was last serviced 6 months prior to listing, with a full functional assessment performed by a certified biomedical technician. The service included a visual inspection for physical damage, verification of sterility integrity, and mechanical testing of the locking mechanism and screw threads. The device has never been implanted or used in a clinical setting, ensuring pristine condition. All components were stored in a controlled environment (15°C to 25°C, <60% humidity) and have maintained their shelf life within the manufacturer's specifications. The device is accompanied by a complete service log, including maintenance records, calibration certificates, and compliance documentation. No repairs or modifications have been performed, and the device is free from any signs of wear or degradat...

Packing List

The device is supplied in a single, sterile, double-wrapped package designed for surgical use. The outer packaging is a rigid, tamper-evident medical-grade plastic case with a secure locking mechanism, labeled with the device name, model number, serial number, and expiration date. The inner packaging consists of a sterile barrier pouch containing the 2.4mm LCP-DRP plate, pre-assembled with locking screws (2.4mm diameter, 10mm to 20mm lengths). The accessory kit is packed separately in a sterile, peel-open pouch, including: (1) 2.4mm locking screws (10 units); (2) precision drill guide; (3) depth gauge; (4) torque-limiting screwdriver set; (5) implant template; (6) sterile drape; and (7) desiccant pack. The packing list includes a detailed component inventory, sterilization certificate (EO sterilization, SAL 10^-6), and a traceability label with the device's unique identifier. The package is labeled with handling instructions, including storage temperature (15°C to 25°C) and humidity...

Additional Information

The Synthes -2.4mm LCP-DRP System is a Class IIb medical device under EU MDR 2017/745 and is FDA-cleared (K183616) for use in bone-conduction hearing implant procedures, including those involving the mastoid and temporal bone. The system complies with ISO 14630:2012 (Non-active surgical implants) and ISO 5832-3:2016 (Metallic materials for surgical implants). It is also compliant with the FDA's Quality System Regulation (21 CFR Part 820) and the EU's Medical Device Regulation (MDR) 2017/745. The device is CE-marked (CE 0123) and carries the UKCA mark for use in the United Kingdom. Clinical applications include treatment of conductive hearing loss, mixed hearing loss, and single-sided deafness (SSD) where bone-conduction implants are indicated. The system is designed to integrate with existing hospital workflows, including compatibility with PACS systems for radiographic imaging and EMR systems for patient record documentation. The device is manufactured by DePuy Synthes, a Johnson & Johnson company, under a certified quality management system (ISO 13485:2016). The system has been used in over 5,000 clinical procedures worldwide, with a documented success rate of 98.2% for implant stability and 96.5% for patient satisfaction at 12-month follow-up. The device is shipped with a comprehensive user manual, surgical technique guide, and a USB drive containing SynCart software (trial version) and instructional videos. The seller provides a certificate of conformity, confirming that the device meets all regulatory and quality standards. The device is suitable for use in operating rooms, ambulatory surgical centers, and specialized ENT clinics. The system's titanium alloy construction ensures biocompatibility, corrosion resistance, and long-term durability, with a minimum expected lifespan of 10 years under normal use conditions. The device is not intended for use in patients with active infections, severe osteoporosis, or other contraindications as specified in the IFU.