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FMSi — Fortschritt Medical Supplies Inc.
PH-FDA: CMDR-2025-04943A

FlexiOss® Ortho

Third-generation flexible bone substitute with TriCurean biphasic formula for orthopedic and traumatology procedures.

Modern implantable biomaterial — biphasic (hydroxyapatite-polymeric), bioactive, supporting bone tissue regeneration and a potential drug carrier. After implantation, it integrates with patient's bone and is slowly remodelled into natural bone tissue, eliminating reoperation.

FlexiOss Ortho — PH-FDA certified hydroxyapatite-polymeric bone substitute for orthopedic trauma surgery

Clinical Evidence

Product Demonstration

Hydration, moldability, and surgical handling of FlexiOss® Ortho

Clinical Video — Trauma Surgery

Live surgical application in comminuted fracture repair with FlexiOss® Ortho

PhilHealth Coverage

PhilHealth Subsidy & Co-Payment Guide

Understand your PhilHealth subsidy allowance and co-payment options for procedures that use FlexiOss® — written for both patients and clinicians.

View PhilHealth Codes
Innovative Properties

What Makes FlexiOss® Ortho Unique

01

Flexible After Soaking

Plastic and bendable — fits individual bone defects by cutting or bending during operation

02

Bio-Compatible

Compatible with natural bone tissue for seamless integration

03

Mechanical Parameters

Similar to those of cancellous bone — structural support

04

Supports Bone Reconstruction

Actively supports the bone reconstruction process

05

Absorbs Blood & Medicine

Absorbs blood and medicine solutions for enhanced drug delivery

06

Bone Tissue Regeneration

Positively affects bone tissue regeneration process

07

Ionic Reactive / Bioactive

High ionic reactivity increases mineralization rate

08

Non-Toxic Material

Thoroughly tested for safety — no cytotoxicity observed

09

Up to 7cm Defects

Can be used for bone defects of up to 7 cm in length

10

Non-Animal Material

Lowers risk of pathogen transmission and allergic reactions

11

Easy to Store & Transport

Simple storage and transportation requirements

TRICUREAN COMPOSITION

Biphasic Formula

The combination of two main compounds was obtained by polymer gelling into an irreversible, collagen-like triple helix — a conformation which does not evoke local inflammation and enables the entrapment of HAP granulate.

Hydroxyapatite (HAP)

Ceramic Phase

Low-sintered, highly porous ceramic

Fully synthetic — high chemical stability

Supports regeneration via enhanced ion uptake

Most stable form of calcium phosphate

Curdlan Polymer

Polymeric Phase

Triple-helix structure (collagen-like)

Neutral for macrophages — no inflammation

Enables flexibility and high absorbency

Provides form stability

AREAS OF APPLICATION

Clinical Applications

01

Comminuted fractures with bone tissue defects

02

Long bone defect filling and reconstruction (up to 5-7 cm)

03

Trauma surgery and emergency medicine

04

Bone pocket filling for tissue regeneration

05

Post-infective cyst removal and filling

06

Bone tumour resection defect reconstruction

07

Osteoporotic bone tissue fracture therapy

08

Bioactive filling of titanium and polyester scaffolds

09

Spinal fusion augmentation

10

Joint revision and arthrodesis procedures

Orthopaedics

Primary application area

Musculoskeletal Trauma

Emergency & reconstructive

Dentistry

Cyst & fistulae treatment

Veterinary

Companion animals

Certifications & Patents

CE

CE Certified

EC No. 1434-MDD-269/2021

European conformity — highest safety standards

FDA

PH-FDA Approved

CMDR-2025-04943A

Certified for orthopedic applications in the Philippines

PAT

Patent Protected

European Patents

Protected across England, Austria, France, Spain, Ireland, Germany, Poland & Italy

Comparative Analysis

FlexiOss® vs Leading Bone-Graft Products

Side-by-side against a PMMA bone cement, a hydroxyapatite ceramic and a β-TCP graft — every figure drawn from each manufacturer's own published documentation.

Comparison of FlexiOss Ortho versus Kyphon PMMA cement, Bongros HA ceramic and ExcelOs beta-TCP across eleven product attributes.
FeatureFlexiOss® OrthoHAP + curdlan compositeKyphon® Xpede™ / HV-R®Medtronic · PMMA cementBongros® HACGbio · HA ceramicExcelOs®CGbio / BioALPHA · β-TCP
Product formPre-formed sterile cylinder (double paper-foil pack)Two-part cement — powder sachet + liquid bottleLoose bone chips in jarsGranulate in jars
Available sizesØ13 mm cylinder — 1, 3 & 5 cm lengths20 g powder + 9 g liquidPre-filled granule jars (multiple volumes)0.3–0.6 mm (ortho) / 0.6–3.0 mm (dental); 5–30 cc
CompositionHAP granules (>100 nm) + curdlan sugar binderSelf-curing PMMA cement (MMA copolymer, barium sulphate, BPO)Hydroxyapatite ceramic (mimics mineral bone)100% high-purity β-TCP
ResorbabilityResorbable HAP; curdlan degrades to glucose (metabolised)100% biodegradable — replaced by autograft
Animal / human tissueNoneNoneNoneNone
Immunological / toxic reactionNone
OsseointegrationExcellent — osteoconductive scaffold; supports vascularizationChemically fuses & grows into bone; preserves space for growthOptimal osteoconduction; rapid bone in-growth
PorosityMicro + macroporous; ~30 µm pores; 68–70%70–80% porous; ~300 µm pores~80% macroporosity; 100–300 µm pores
Absorption capacityAbsorbs blood/plasma → plastic, elastic & trimmable
X-ray visibilityYesYes
IndicationsSmall & large defects — orthopedics, traumatology, dental & veterinaryPathological vertebral fractures (kypho/vertebroplasty); tumours & metastasesDental only — ridge augmentation, socket filling, sinus lift, periapical defectsSpine, joint revision, fracture repair, autograft extension, donor-site filler

  indicates the specification was not stated in that product's published manufacturer documentation. Comparative information is sourced from manufacturer materials and provided for clinical reference.

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01vs Kyphon® PMMA cement

FlexiOss® needs no special mixer or delivery device. PMMA cements cure exothermically — the local temperature spike can cause cell necrosis — and are prone to brittleness, depolymerisation, post-implant inflammation and reoperation from implant loosening. FlexiOss® avoids all of these.

02vs Bongros® HA chips

FlexiOss® is a flexible, cut-to-size implant rather than loose, crumbly granules, and serves orthopedics, dentistry and veterinary use — whereas Bongros HA is dental-only. FlexiOss® Dent can even be used without a membrane and soaked in medication (e.g. metronidazole).

03vs ExcelOs® β-TCP

FlexiOss® is supplied as a moldable, trimmable cylinder that absorbs blood and plasma for single-step intra-operative application, rather than loose β-TCP granulate — and spans orthopedic, dental and veterinary indications.

Scientific Research

Published Research

07 peer-reviewed papers
01

Characteristics and application of FlexiOss® bone substitute material in trauma-orthopedic patients

Lukasiewicz P.

Medical Inventi · 2025

02

Preliminary Results of Surgical Treatment for Enchondroma Using a Novel Bioactive and Osseoconductive HAP/β-Glucan Bone Substitute FlexiOss® — Case Series

Kotrych D., Ciechanowicz D., Bielewicz F., Baryluk A., Podsiadlo S., Zietek P.

J. Clin. Med. 2025, 14(11), 3738 · 2025

03

Behavior of new hydroxyapatite/glucan composite in human serum

Borkowski L., Lubek T., Jojczuk M., Nogalski A., Belcarz A., Palka K., Hajnos M., Ginalska G.

J. Biomed. Mater. Res. Part B., 2018, 106B(7), 2653-2664 · 2018

04

Unexpected reaction of new HAp/glucan composite to environmental acidification: Defect or advantage?

Borkowski L., Kiernicka M., Belcarz A., Palka K., Hajnos M., Ginalska G.

Biomed. Mater. Res. B Appl. Biomater. 2017, 105(5), 1178-1190 · 2017

05

The comparison study of bioactivity between composites containing synthetic non-substituted and carbonate-substituted hydroxyapatite

Borkowski L., Sroka-Bartnicka A., et al.

Mater. Sci. Eng. C Mater. Biol. Appl. 2016, 62, 260-267 · 2016

06

Biphasic mode of antibacterial action of aminoglycoside antibiotics-loaded elastic hydroxyapatite-glucan composite

Belcarz A., Zima A., Ginalska G.

Int. J. Pharm. 2013, 454, 285-295 · 2013

07

Application of β-1,3-glucan in production of ceramics-based elastic composite for bone repair

Belcarz A., Ginalska G., Pycka T., et al.

Centr. Eur. J. Biol. 2013, 8, 534-548 · 2013

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