These titanium foam materials are intended for use by qualified medical device manufacturers and orthopedic implant companies. For investigational use only in the United States. Not for direct sale to patients or healthcare providers for implantation.
All medical implant devices must comply with FDA 21 CFR Part 820 (Quality System Regulation) and obtain appropriate regulatory clearance before clinical use.
Porous Metal Implants with 60-80% Porosity - Prevents Bone Resorption, Accelerates Osseointegration
Independent research validates the superior performance of titanium foam implants for medical applications
Quadbeck et al., Materials Science Forum (2010)
Study: Titanium foam for vertebral body replacement applications
Results: Complete bone ingrowth within 6 weeks, no stress shielding observed, superior mechanical integration
Singh & Lee, ACS Omega 2022
Study: Novel titanium foam production reducing stress shielding in implants
Results: Elastic modulus 15.5-36 GPa (vs 110 GPa for solid titanium), closer match to human bone properties
Frontiers in Bioengineering and Biotechnology
Study: Porous titanium construction for enhanced osteogenesis
Results: Enhanced cell adhesion, proliferation, and differentiation compared to solid titanium surfaces
65-75% Reduction
in stress shielding vs solid titanium
30-50% Faster
osseointegration time
40% Reduction
in implant loosening rates
Improved Outcomes
in load-bearing applications
While we cannot disclose specific customers due to NDAs, our titanium foam materials have been specified for use in these applications
Application: Acetabular cups with porous coating for enhanced fixation
Specification: 400-600 μm pore size, 60-70% porosity, Ti-6Al-4V ELI alloy
Clinical Benefit: 50% faster bone ingrowth vs traditional plasma-sprayed coatings
Typical FDA Pathway: 510(k) clearance with predicate devices
Application: Lumbar interbody fusion devices with porous structure
Specification: 200-400 μm pores, optimized strut thickness, Ti-6Al-4V ELI alloy
Clinical Benefit: 30% higher fusion rates in clinical trials vs PEEK cages
Typical FDA Pathway: 510(k) with biomechanical testing
Application: Root form implants with porous surfaces for osseointegration
Specification: 100-300 μm pore size, pure titanium Grade 4, surface roughness Ra 2-4 μm
Clinical Benefit: Reduced healing time from 6 months to 3-4 months
Typical FDA Pathway: 510(k) with dental predicate devices
We work with medical device manufacturers to optimize titanium foam properties for specific applications:
Custom pore sizes from 50-800 μm depending on application requirements and desired bone ingrowth characteristics.
Precise control over porosity (40-85%) to match mechanical properties with surrounding bone tissue.
Ability to manufacture patient-specific implants using advanced imaging and manufacturing techniques.
Full FDA compliance and ISO 13485 certification for medical device manufacturing
Premarket notification clearance for medical devices
Medical device quality management system
Current Good Manufacturing Practice per 21 CFR Part 820
Biological evaluation of medical devices
| Test | Standard | Status | Test Laboratory |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | ✓ Pass | Nelson Laboratories (ISO 17025) |
| Sensitization | ISO 10993-10 | ✓ Pass | Nelson Laboratories (ISO 17025) |
| Irritation | ISO 10993-10 | ✓ Pass | Nelson Laboratories (ISO 17025) |
| Systemic Toxicity | ISO 10993-11 | ✓ Pass | Nelson Laboratories (ISO 17025) |
| Genotoxicity | ISO 10993-3 | ✓ Pass | Nelson Laboratories (ISO 17025) |
| Implantation | ISO 10993-6 | ✓ Pass | Nelson Laboratories (ISO 17025) |
Full material traceability, certificates of conformance, and test reports for your 510(k) submission.
Access to our Quality Assurance/Regulatory Affairs team for submission strategy guidance.
Assistance with design validation testing, sterilization validation, and packaging testing.
Support in preparing the design history file (DHF) and device master record (DMR) requirements.
Answers to the most common questions from orthopedic companies and medical device manufacturers
Porous titanium materials must meet several FDA requirements for implant applications:
✓ We provide complete material traceability documentation
✓ ASTM F136 certification for every production batch
✓ ISO 10993 biocompatibility test reports from accredited labs
✓ Technical file documentation support for your submission
✓ Regulatory consultation with our QA/RA team
✓ Sterilization validation guidance for your specific process
While the base material (porous titanium) is similar, specifications differ significantly between dental and orthopedic applications:
Pore size: 100-300 μm (smaller for faster integration in dense bone)
Porosity: 50-70% (higher density for screw thread strength)
Surface area: Often combined with micro-textured surfaces (Ra 2-4 μm)
Typical applications: Root form implants, abutments, healing caps
Healing time: 3-6 months osseointegration
Load requirements: Primarily compressive loads during chewing
Pore size: 300-600 μm (larger for vascularization in cancellous bone)
Porosity: 60-80% (lower modulus to match bone stiffness)
Surface area: Optimized for bone ingrowth, not necessarily microroughness
Typical applications: Hip cups, knee components, spinal cages, trauma plates
Healing time: 6-12 weeks for stable fixation
Load requirements: Complex loading (compression, tension, shear, torsion)
We work with both dental and orthopedic device manufacturers to optimize pore size, porosity, mechanical properties, and surface characteristics for specific applications. Our technical team can help you select the optimal parameters for your device.
Pricing depends on porosity, volume, specifications, and manufacturing complexity:
| Material | Raw Material Cost | Processing Cost | Total | Notes |
|---|---|---|---|---|
| Solid Titanium Bar (Ti-6Al-4V) | $40-60/kg | $20-40/kg | $60-100/kg | Standard machining, high material yield |
| Porous Titanium Foam (60% porosity) | $45-70/kg | $80-150/kg | $125-220/kg | Powder metallurgy, precise porosity control |
| Porous Titanium Foam (80% porosity) | $40-65/kg | $100-180/kg | $140-245/kg | Higher porosity = more complex manufacturing |
| Additively Manufactured Porous Titanium | $80-120/kg | $200-400/kg | $280-520/kg | 3D printed, patient-specific geometries |
Reduced stress shielding = fewer revision surgeries (average revision hip surgery costs $75,000+)
Faster osseointegration = shorter hospital stays and quicker return to normal activities
Better patient outcomes = potential for higher reimbursement rates and premium pricing
Lighter implants = improved patient comfort and mobility during recovery
For production quantities (typically 50+ units), we offer significant volume discounts. Contact us with your specific requirements for a detailed quote.
Partner with our medical materials specialists to develop FDA-compliant porous titanium implants. Get started with our comprehensive medical-grade sample kit including full regulatory documentation.
Contact Our Medical Materials Team:
Email: medical@prometheanfoam.com
WhatsApp: +1 (406) 479-0215
Manufacturing: Sheridan, WY, USA | ISO 13485:2016 Certified | FDA Registered
Standard lead time: 4-6 weeks with full regulatory documentation