{"id":2979,"date":"2024-09-27T11:16:18","date_gmt":"2024-09-27T02:16:18","guid":{"rendered":"https:\/\/hoyats.cr8ive.fun\/products\/product_details\/refit\/"},"modified":"2026-02-27T10:08:19","modified_gmt":"2026-02-27T01:08:19","slug":"refit","status":"publish","type":"medical_products","link":"https:\/\/www.hoyatechnosurgical.co.jp\/en\/products\/product_details\/refit\/","title":{"rendered":"ReFit"},"content":{"rendered":"\n

Features<\/h2>\n\n\n\n

Flexible operability<\/h3>\n\n\n\n

ReFit becomes elastic when hydrated. As a result, it can be packed or placed to bony voids without leaving any gaps. It can be easily processed with a scalpel or scissors.<\/p>\n\n\n

\n
\"\"<\/figure>\n<\/div>\n\n\n

Structure and composition similar to human bone<\/h3>\n\n\n\n

Structure and composition was approximated to human bone up to nano-level.<\/p>\n\n\n\n

Absorption and replacement in vivo<\/h3>\n\n\n\n

ReFit is incorporated to the bone remodeling cycle after implantation to be replaced to bone tissues.<\/p>\n\n\n\n

Promotion of bone regeneration<\/h3>\n\n\n\n

ReFit is confirmed to be superior in bone regeneration by clinical trial.<\/p>\n\n\n\n

\u203bCompared with the similar products when filled in bone defects caused by bone disease like bone tumor, trauma or after harvesting autograft.<\/p>\n\n\n\n

Improved compensatory properties<\/h3>\n\n\n\n

ReFit can be smoothly refilled into the laminoplasty basket.
In addition, ReFit can be easily processed with a scalpel.<\/p>\n\n\n

\n
\"\"<\/figure>\n<\/div>\n\n\n

Can be used with the Spinal Basket Plate and Basket Plate System 2.<\/p>\n\n\n\n

<\/p>\n\n\n\n

Physical Properties<\/h2>\n\n\n
\n
\"\"<\/figure>\n<\/div>\n\n\n
Components<\/td>Inorganic component\uff1aLow crystalline Hydroxyapatite
Organic component: Type I collagen (derived from porcine dermis)<\/td><\/tr>
Composition(weight ratio)<\/td>Hydroxyapatite (HAp)\uff1aca 80wt%
Collagen (Col)\uff1aca 20wt%<\/td><\/tr>
Porosity<\/td>95%<\/td><\/tr>
Pore diameter<\/td>100\u2212500\u03bc\uff4d<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Trials<\/h2>\n\n\n\n

Clinical trial of ReFit was conducted in accordance to \u201cGuidelines for clinical test for medical devices (Medical device GCP)\u201d Comparative study was performed using a mormal \u03b2-tricalcium phosphate as a control device for absorbable bone graft.<\/p>\n\n\n\n

\u25a0Period of observation\uff1a24 weeks post operation\u3000
\u25a0Facilities for clinical trial: seven facilities\u3000
\u25a0Number of cases: ReFit 63 cases, \u03b2-TCP\uff1a63 cases<\/p>\n\n\n\n

Efficacy Evaluation<\/h3>\n\n\n\n

Radiographic study revealed that ReFit group was superior to \u03b2-TCP group regarding bone formation in 18 weeks and thereafter. In 24 weeks, remarkable efficiency rate of ReFit group by filling volume was 50% or higher for every filling volume irrelevant to the volume (71.4% for filling volume 10-30mL). On the other hand for \u03b2-TCP group, remarkable efficiency rate decreased with increasing the filing volume (0% for filling volume 10-30mL)<\/p>\n\n\n

\n
\"\"<\/figure>\n<\/div>\n\n\n

Product Line-up<\/h3>\n\n\n\n
\"\"<\/figure>\n\n\n\n
\n
\n
\"\"
PB-101010<\/figcaption><\/figure>\n<\/div>\n\n\n\n
\n
\"\"
PB-103020<\/figcaption><\/figure>\n<\/div>\n\n\n\n
\n
\"\"
PB-306H1H<\/figcaption><\/figure>\n<\/div>\n<\/div>\n\n\n\n
Item No.<\/td>PB-101010<\/td>PB-103020<\/td>PB-306H1H
(2.0ML)<\/td><\/tr>
size<\/td>10\u00d710\u00d710mm<\/td>10x30x20mm<\/td>30×6.5×1.5mm<\/td><\/tr>
Packaging Unit\/Box<\/td>1 piece (1.0 mL)<\/td>1 piece (6.0 mL)<\/td>7 sheets (2.0mL)<\/td><\/tr>
Category name abbreviation<\/td>Artificial bone: AB-06-2<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

[Contraindications\/Prohibitions]
\u30fbAllergic subjects with medical history of anaphylaxis, severe allergic subjects, or patients with allergy against drugs containing porcine collagen.
\u30fbDo not reuse

\u30fbFor details, please refer to the product brochure.<\/p>\n\n\n\n

Related Products<\/h3>\n\n\n\n