—— Bioactive Glass · Antimicrobial · Clinical-Proven
S53P4 Bioactive Glass
The only bioactive glass with Level 1–2 clinical evidence for bone infection treatment. Proven osteoconductive and bacteriostatic — in the same material.
53%
23%
20%
4%
SiO₂
Na₂O
CaO
P₂O₅
99+
99%+
5
ISO
Countries Served
Phase Purity
Product Lines
9001
US, EU, APAC and beyond — worldwide direct shipping.
XRD-verified every production batch. No exceptions.
45S5, 58S, 13-93, S53P4 glass + nHAp ceramics.
Certified quality and environmental management systems.
What Makes S53P4 Different ——
Two mechanisms.
One material.
Most bone substitutes do one thing. S53P4 does two — simultaneously. That dual action is why it remains the reference material for infected bone defects more than three decades after its introduction.
Osteoconductive
S53P4 releases Si⁴⁺, Ca²⁺, Na⁺, and PO₄³⁻ ions that raise local pH, form a silica gel layer, and trigger crystalline hydroxyapatite precipitation — activating osteoblasts for new bone formation. The glass is ultimately fully resorbed as natural bone replaces it.
HCA:Hydroxyapatite crystal layer forms within hours of physiological fluid contact
100%:Resorbable — fully replaced by natural bone over time
Bacteriostatic
Ion release raises local pH above 11 and increases osmotic pressure — creating an environment hostile to bacterial survival and biofilm formation. Effective against MRSA and other multidrug-resistant organisms without systemic antibiotic load.
MRSA: Proven activity against methicillin-resistant S. aureus in vitro and in vivo
pH>11: Local pH elevation creates bactericidal microenvironment at implant site
Primary Indication——
The reference standard for
bone infection
Chronic osteomyelitis and septic non-unions are among the most difficult conditions in orthopedic surgery. S53P4 addresses the two core challenges simultaneously — dead space management and infection control — without relying solely on systemic antibiotics.
01.Chronic Osteomyelitis
91.7% infection eradication rate (22/24 patients) in a single-center series. Used as dead space filler post-debridement.
02.Septic Non-Unions
78.6% achieved both fracture healing and infection resolution at 9.1 ± 4.9 months mean follow-up.
03.Diabetic Foot Osteomyelitis
Clinically validated for infected diabetic foot procedures — particularly relevant given rising global diabetes prevalence.
Peer-Reviewed Evidence——
The clinical record
speaks for itself
Peer-Reviewed Evidence——
PRISMA-Grade Meta-Analysis
99 clinical studies from 1990–2024 analyzed. Highest level of evidence confirmed in 5 surgical specialties. Published in Advanced Healthcare Materials.
iewed Evidenc——
91.7% Infection Eradication
Single-center series of 38 patients with chronic osteomyelitis and septic non-unions. Mean follow-up 9.1 months. No implant-related complications.
Antimicrobial · 2022——
Superior to 45S5 vs Biofilm
Head-to-head comparison of S53P4 vs 45S5 in antibacterial and antibiofilm activity. S53P4 demonstrated superior performance against clinical biofilm isolates.
Technical Profile——
Every number
documented
Composition
SiO₂ / Na₂O / CaO / P₂O₅
Phase Purity
≥ 99% (XRD)
Particle Size — Powder
< 45 μm
Particle Size — Granules
500–800 μm
Heavy Metals (Pb)
≤ 10 ppm
Synthesis Method
Melt-Derived
Sterilization
EtO / Gamma
Shelf Life
24 Months
S53P4 vs 45S5——
Which grade is
right for you?
Feature
S53P4 (This Product)
45S5
SiO₂ Content
53%
45%
Antibacterial Activity
Clinically proven (MRSA)
Moderate
Osteomyelitis Treatment
Level 1–2 evidence
Limited evidence
Bone Regeneration Speed
Moderate-fast
Fast (highest bioactivity)
Spinal Fusion
✓ Validated
Off-label
Certifications
✓ 500–800 μm
Limited
Oral Care Formulation
Possible
✓ Primary use
Best For
Infected bone · Spine · Trauma
Dental · Oral care · Research
Who We Serve
Common questions
How does S53P4 differ from 45S5?
S53P4 has higher SiO₂ (53% vs 45%) and lower CaO content. This gives it a more sustained ion release profile, stronger antibacterial activity, and broader clinical validation — particularly for infected bone applications. 45S5 has faster HCA formation and is preferred for dental and oral care formulations.
Is your S53P4 suitable for ISO 10993 regulatory submissions
Yes. We provide full ICP-MS heavy metal data (Pb ≤10 ppm), XRD phase purity (≥99%), and microbial count documentation. SGS or Intertek third-party reports are available on request for bulk orders.
What particle sizes are available?
Standard grades: powder (<45 μm) and granules (500–800 μm). Custom particle sizes between 45 μm and 2 mm are available from 500g MOQ — contact us with your target specification.
What is the lead time for bulk orders to the US or EU?
Standard orders ship within 5–8 business days. Bulk and custom-size orders take 3–6 weeks. We support FOB Shenzhen, CIF, and DDP terms with full export documentation.
Can S53P4 be sterilized for implant use?
Yes. EtO (ethylene oxide) and gamma irradiation sterilization are available on request. Minimum batch for sterilized supply is typically 500g. Lead time extends by 2–3 weeks for sterilized orders.
Do you supply putty or scaffold forms?
Currently we supply powder and granule forms. Putty formulations (granules + binder) and custom scaffold forms are available as development projects — contact us with your application requirements and we will assess feasibility.