Sternal Fixation System

Product Overview

The Sternal Fixation System is a specialized internal fixation platform engineered for sternal closure, fracture stabilization, and chest wall reconstruction. Manufactured from high-strength titanium alloy, this comprehensive system includes H-shaped and star-shaped plates for manubrium fixation, contoured plates for various sternal positions, straight locking plates for rib-to-rib fixation, and PEEK sternal fixation bands. The system's most distinctive feature is the emergency release pin—a U-shaped connecting element that allows for rapid sternal re-entry during cardiovascular emergencies. The locking mechanism provides angular-stable fixation, ensuring excellent stability even in patients with compromised bone quality. With low-profile plate design (thickness 1.5 mm), left/right differentiation with color coding, and comprehensive sizing options, this system addresses the full spectrum of sternal fixation needs while minimizing soft tissue irritation and postoperative complications.

Indications for Use

The Sternal Fixation System is indicated for the following clinical scenarios:

• Median sternotomy closure following cardiac surgery, particularly in patients at high risk for dehiscence, including those with obesity, chronic obstructive pulmonary disease (COPD), and diabetes mellitus.

• Sternal fractures requiring stable internal fixation to restore chest wall integrity and alleviate pain.

• Emergency re-entry during cardiovascular emergencies, where the rapid release mechanism enables immediate access to the mediastinum.

• Chest wall tumor resection and reconstruction, where large defects require structural support and stabilization.

• Sternal non-unions and malunions requiring revision fixation with enhanced stability.

• Rib fractures requiring rib-to-rib fixation using straight locking plates.

• Pectus excavatum (funnel chest) correction, where pre-contoured plates provide structural support for chest wall remodeling.

• Osteoporotic sternal fixation where the locking mechanism ensures stable fixation despite poor bone quality.

Key Advantages

The Sternal Fixation System offers a comprehensive range of clinical benefits that address the unique challenges of sternal and chest wall surgery.

Emergency Release Pin for Rapid Re-entry – All fixation plates in this system consist of two segments connected by a U-shaped release pin. In the event of a cardiovascular emergency, this design allows for simple, rapid removal of the plate segments without the need for cutting or extensive dissection, enabling immediate access to the mediastinum. This feature is particularly valuable in cardiac surgery where time-critical interventions may be necessary.

Locking Mechanism for Superior Stability – The fixation plate functions as an internal external fixator, with the tight locking between the screw head and the threaded hole in the plate ensuring excellent fixation even in patients with poor bone quality. This angular-stable construct provides rigid segmental stabilization that reduces the risk of sternal dehiscence and promotes predictable bone healing.

Diverse Range of Plate Specifications – The system includes H-shaped and star-shaped plates specifically designed for manubrium fixation, contoured plates for various positions along the sternum, and straight locking plates for rib-to-rib fixation. This comprehensive offering ensures that surgeons can select the optimal implant for each specific anatomical requirement.

Low-Profile Design with Color Coding – All plates feature a low-profile design with a thickness of 1.5 mm, minimizing soft tissue irritation and reducing patient discomfort. Plates are supplied in left and right versions, differentiated by surface color for easy intraoperative identification, reducing surgical time and the risk of incorrect placement.

Titanium Alloy Construction – Manufactured from pure titanium, the implants offer excellent biocompatibility, corrosion resistance, and MRI compatibility. The elastic modulus of titanium is closer to that of human bone than stainless steel, providing physiological load transmission and reducing stress shielding during the healing process.

PEEK Sternal Fixation Bands – The system also includes PEEK (polyetheretherketone) sternal fixation bands with lengths ranging from 130 mm to 400 mm in 10 mm increments. PEEK offers excellent biocompatibility, is MRI-compatible, and does not produce X-ray artifacts, allowing for clear postoperative imaging. The system includes dedicated introducers and shaping instruments for precise application.

Pre-contoured Plates for Rib Anatomy – The pre-contoured plates are shaped to match rib anatomy, requiring only minor intraoperative adjustments for perfect bone apposition. This design reduces surgical time and improves implant-bone conformity, enhancing fixation stability and patient comfort.

Additional Clinical Benefits – The system facilitates rapid sternal closure, effectively reducing surgical time. It reduces the risk of sternal cutting (wires cutting through bone) and decreases postoperative pain. Patients benefit from smaller incisions, less tissue trauma, and faster recovery times. The lightweight titanium alloy construction significantly reduces the patient's perceived burden of carrying the implant.

Technical Specifications & Sizing

Size Range Overview

The Sternal Fixation System encompasses four plate families, two screw types, and PEEK sternal bands, providing comprehensive coverage for all sternal and chest wall fixation requirements.

Detailed Dimension Tables

H-Lock Plates

Star Locking Plates

Straight Locking Plates

Self-Tapping Locking Screws (3.0 mm Diameter)

Self-Tapping Self-Drilling Locking Screws (3.0 mm Diameter)

Emergency Release Pin

PEEK Sternal Fixation Bands

Recommended Companion Instrument Set

The Sternal Fixation System requires specialized instruments for precise implantation. The comprehensive instrument set includes:

RFQ – Request for Quotation

Q1: How does the emergency release pin work, and what is the recommended technique for rapid re-entry?
A: The emergency release pin is a U-shaped connecting element that joins the two segments of each fixation plate. In the event of a cardiovascular emergency requiring immediate mediastinal access, the pin can be quickly pulled out using a specialized extraction instrument or a standard forceps. Once removed, the two plate segments separate, allowing the sternum to be opened without the need for cutting through bone or metal. This design enables re-entry in under 30 seconds, significantly faster than traditional wire cutting or screw removal, and is a critical safety feature for cardiac surgery patients who may require emergent resternotomy.

Q2: What is the difference between the self-tapping screw and the self-tapping self-drilling screw, and when should each be used?
A: The self-tapping screw requires a pre-drilled pilot hole before insertion and is recommended for use in dense cortical bone where precise trajectory control is essential. The self-tapping self-drilling screw incorporates a fluted cutting tip that simultaneously drills and taps, eliminating the need for a separate drilling step. This version is particularly advantageous in osteoporotic bone where a pre-drilled hole might risk over-sizing, and it reduces surgical time by combining two steps into one. For most sternal fixation procedures, the self-tapping self-drilling screw is preferred due to its efficiency and reduced risk of thermal necrosis from drilling. Both screw types are available in 8–24 mm lengths and are fully compatible with the 3.0 mm locking holes in all plates.

Q3: Can the PEEK sternal fixation bands be used in patients with titanium allergies or sensitivity?
A: Yes, PEEK (polyetheretherketone) is a synthetic polymer with excellent biocompatibility and is completely metal-free, making it an ideal choice for patients with known titanium allergies or metal sensitivities. PEEK is also fully MRI-compatible and produces no imaging artifacts, allowing for clear postoperative assessment of sternal healing. The bands are available in lengths from 130 mm to 400 mm in 10 mm increments, accommodating a wide range of sternal dimensions. The system includes dedicated introducers and shaping instruments to facilitate precise band placement and tensioning.

Q4: What is the recommended postoperative imaging protocol for patients with this sternal fixation system?
A: The titanium alloy plates and screws are fully MRI-compatible, allowing for safe and artifact-free postoperative imaging at any field strength. For standard postoperative follow-up, we recommend anteroposterior and lateral chest X-rays to assess plate position and sternal alignment. In cases where CT imaging is required (e.g., to evaluate fusion or identify non-union), the titanium implants produce minimal scatter, and the images remain diagnostically interpretable. For patients with PEEK bands, X-ray imaging will not visualize the bands, but this does not interfere with assessment of the underlying bone or plate position. We recommend baseline imaging at the 6-week, 3-month, and 12-month postoperative intervals.

Q5: Are the plates available in both left and right anatomical versions, and how do I distinguish between them?
A: Yes, all contoured plates are available in both left and right versions to accommodate sternal and rib anatomy. The plates are differentiated by surface color—typically one side is anodized with a distinct color while the other remains raw titanium. This color-coding system allows for rapid intraoperative identification, reducing surgical time and the risk of incorrect placement. The plate packaging is also clearly labeled with the side designation. For the H-shaped and star-shaped plates used for manubrium fixation, the plates are symmetric and do not have left/right differentiation. Straight locking plates for rib-to-rib fixation are also symmetrical and can be used on either side.

Q6: What are the standard packaging configurations, shelf life, and minimum order quantities for this system?
A: All implants are supplied non-sterile and must be sterilized prior to use (steam sterilization at 134°C for 18 minutes is recommended). The shelf life is indefinite when stored in a cool, dry environment. The standard MOQ is 10 units per plate size, but we are happy to accommodate mixed orders and trial kits for hospital evaluations. For the PEEK sternal bands, we recommend ordering a set of the most commonly used lengths initially (typically 180–300 mm). Screws can be ordered in boxes of 10 units (mixed lengths are acceptable). Instrument sets are typically supplied as a complete set (non-sterile) with a dedicated sterilization tray. Please contact our export team to discuss specific order configurations and pricing for large-volume commitments.