INITIAL C™

INITIAL C™
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INITIAL C™

Product catalog summary
Overview: The document details the Initial C™ kits, designed for clavicle surgeries. These pre-sterilized, ready-to-use kits include sterile implants and single-use instruments, ideal for urgent cases. They aim to optimize handling, reduce costs, and minimize contamination risks.
Specifications: The kits feature a variety of plates and screws for different clavicle parts. Plates are precontoured for anatomical fit and available in bendable versions. The kits include monoaxial and polyaxial locking systems, with screws made from titanium alloy.
Indications and Contraindications: Implants are for fixation of clavicle fractures, mal-unions, non-unions, and osteotomies in adults. Contraindications include serious vascular issues, infections, poor bone quality, and material allergies.
Technical Features: Kits offer a range of plates, including midshaft and lateral plates, with bendable options. The fixation system includes monoaxial holes for cortical and locking screws, and polyaxial locking holes for enhanced stability.
Surgical Technique: The document outlines the surgical technique for using midshaft lateral and lateral plates, detailing steps for drilling, screw insertion, and plate positioning, emphasizing the use of specific tools for accurate placement.
Kit Contents: Each kit includes instruments and implants like screwdrivers, guide gauges, drill bits, and screws of various sizes, with detailed references for each component, including sterile and non-sterile options.
Safety and Cost Efficiency: Initial C™ kits are fully traceable, have a 5-year shelf life, and eliminate costs related to cleaning and sterilization. They are designed to be cost-effective and ensure safety by minimizing contamination risks.
Additional Information: The document references additional kits, such as removal and rescue kits, and stresses the importance of clinical judgment and regulatory practices when using these products.
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Catalog excerpts

INITIAL C™-2

With a non sterile standard kit Calling on medical staff Complex traceability Suppliers’ deadline Cleaning Decontamination Bulky storage Prevents an effective solution & a quick response Defective sterilization Damaged instrumentation INCREASED RISKS NON OPTIMIZED surgery URGENT SURGICAL CASES COMPROMISED

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INITIAL C™-3

Controlled stocks Simplified control Cleaning Decontamination Sterilization An effective solution & a quick response expenses READY-TO-USE FOR SURGERY Optimized handling of URGENT SURGICAL CASES Optimized storage with state-of-the-art implants

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INITIAL C™-4

Safety: The Initial C™ kit is fully traceable and has a shelf life of 5 years. Its instrumentation and implants are “always new” and have never been opened or used before. Available when needed: The Initial C™ kit comes pre-sterilized and ready to use. The combination of sterile implants and single use instrumentation in a single packaging makes Initial C™ ideal for use in urgent surgical cases. Initial C™ kit can be easily stored in the operating room because of its small size. The combination of sterile implants and sterile single-use instrumentation minimizes contamination risks. Initial C™...

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INITIAL C™-5

Technical features The implants of the Initial C™ range are dedicated to the fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle in adults. • Serious vascular deterioration, bone devitalization. • Pregnancy. • Acute or chronic, local or systemic infections. • ack of musculo-cutaneous cover, severe vascular deficiency affecting the concerned area. L • nsufficient bone quality preventing a good fixation of the implant into the bone. I • uscular deficit, neurological deficiency or behavioural disorders which could submit the osteosynthesis to abnormal mechanical strains....

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INITIAL C™-6

Technical features Surgical technique Monoaxial locking system Example: surgical technique with a midshaft lateral plate (KIT-CML2D) Polyaxial holes: Ø2.8 mm locking screws (SDT2.8LxxD), The threads under the screw head and inside the hole have strictly the same characteristics. Oblong hole to facilitate the positioning of the plate: Ø3.5 mm cortical screw (CT3.5LxxD), Handle for guide gauge FEATURES - The screw head is stopped in the hole, ensuring its locking, - The screw head is buried in the plate, - Plate and screws are all made of titanium alloy. Before performing the drilling into the...

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INITIAL C™-7

Surgical technique Option 2 1. Using the midshaft and midshaft lateral templates (ANC838), define the suitable plate, then determine the appropriate kit. 2. Position the plate using the ‘LAT’ and ‘MED’ marks. 3. Snap the handle for guide gauge and perform the drilling using Ø2.7 mm threaded guide gauge into the lateral oblong hole. Option 1: Determine the screw length using the gauge. Option 2: Determine the screw length usingthe length gauge. Final result 4. Then insert the Ø3.5 mm light blue cortical screw using the T15 screwdriver. Repeat the same procedure for the medial oblong hole. 5. Using...

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INITIAL C™-8

Surgical technique Example: surgical technique with a lateral plate (KIT-CL2D) 1. Using the lateral templates (ANC839), define the suitable plate, then determine the appropriate kit. 2. Snap the handle for guide gauge and perform the drilling using the Ø2.7 mm threaded guide gauge (blue) into the lateral oblong hole. Option 1: Determine the screw length using the gauge. Option 2: Determine the screw length using the length gauge. 3. Insert the Ø3.5 mm light blue cortical screw using the T15 screwdriver (blue). Repeat the same procedure for the medial oblong hole. 4. Using the Ø2.0 mm threaded...

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INITIAL C™-9

Initial C™ kits - References Midshaft and midshaft lateral clavicle kits content INITIAL C ™ KITS - MIDSHAFT PLATES AND MIDSHAFT LATERAL PLATES INITIAL C™ KITS CONTENT - IMPLANTS Clavicle kit - Midshaft part - Size 2 - Right Clavicle kit - Midshaft part - Size 2 - Left Clavicle kit - Lateral midshaft part - Size 1 - Right Clavicle kit - Lateral midshaft part - Size 1 - Left Clavicle kit - Lateral midshaft part - Size 2 - Right Clavicle kit - Lateral midshaft part - Size 2 - Left Clavicle plate - Midshaft part - Size 2 - Right or Left Clavicle plate - Lateral midshaft part - Size 1 - Right or...

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INITIAL C™-10

Initial C™ kits - References Lateral clavicle kits content INITIAL C ™ KITS - LATERAL PLATES INITIAL C™ - CLAVICLE KITS CONTENT - IMPLANTS Clavicle kit - Lateral part - Size 1 - Right Clavicle kit - Lateral part - Size 1 - Left Clavicle kit - Lateral part - Size 2 - Right Clavicle kit - Lateral part - Size 2 - Left Clavicle kit - Bendable - Lateral part - Size 2 - Right Clavicle kit - Bendable - Lateral part - Size 2 - Left INITIAL C™ KITS CONTENT - INSTRUMENTS Description Clavicle plate - Lateral part - Size 2 - Right or Left Bendable clavicle plate - Lateral part - Size 2 - Right or Left Clavicle...

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INITIAL C™-11

Initial C™ - References Additional kits Additional implants Sterile screws Locking screw - Ø2.8 mm - L 10 mm - Sterile Locking screw - Ø2.8 mm - L 12 mm - Sterile Locking screw - Ø3.5 mm - L 10 mm - Sterile Locking screw - Ø3.5 mm - L 12 mm - Sterile Locking screw - Ø2.8 mm - L 14 mm - Sterile Locking screw - Ø2.8 mm - L 16 mm - Sterile Locking screw - Ø2.8 mm - L 18 mm - Sterile Locking screw - Ø2.8 mm - L 20 mm - Sterile Locking screw - Ø2.8 mm - L 22 mm - Sterile Locking screw - Ø2.8 mm - L 24 mm - Sterile STANDARD CORTICAL SCREWS – Ø3.5 mm* Ref. Standard cortical screw - Ø3.5 mm - L 10 mm...

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INITIAL C™-12

NEWCLIP USA 642 Larkfield Center Santa Rosa CA 95403, USA Phone : + 1 707 230 5078 - [email protected] www.newclipusa.com Brochure EN - Initial-C - Ed.5 - 05/2020 - Medical devices: class IIb - CE 1639 SGS BE - US Class: II - Read labeling and instructions before use. Right Clavicle Superior Lateral Size 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.