Spine cages. Cranial plates. Dental implants.

We operate ISO 9001-compatible workflow and provide documentation satisfying ISO 13485-certified customer requirements. We are not ISO 13485-certified ourselves (would require customer certification involvement). Our implantable medical customers hold ISO 13485 and use us for Tier-2 component manufacturing with appropriate quality documentation. For full ISO 13485 medical device production, partnership with ISO 13485-certified manufacturers available.

Full traceability from material heat to finished implant required. Documentation: material certificate (EN 10204 3.1 or AMS equivalent), mill heat with chemical composition, mechanical properties, any processing (heat treatment, HIP), dimensional inspection records, lot tracking for implantable medical. Documentation archive retained 25+ years per FDA requirements. Our medical work maintains this documentation chain standard.

Gr.23 (ASTM F136) = Ti-6Al-4V ELI (Extra Low Interstitial). Lower iron, oxygen, and carbon content than standard Gr.5 (ASTM F1472). Benefits: better fracture toughness, better fatigue life, more ductile behavior. Used for permanent implants (orthopedic, spinal, dental) where material performance matters long-term. Cost: same as Gr.5. Specify Gr.23 (ASTM F136) for any permanent implant; Gr.5 (F1472) acceptable for temporary hardware.

PEEK-OPTIMA (Invibio proprietary grade): FDA 510(k) cleared implant-grade PEEK. Bone-like modulus (~3.5 GPa vs bone 15 GPa) reduces stress shielding — bone grows adjacent to PEEK implant without atrophy. Radiolucent (visible through X-ray), allowing fusion verification. Standard for spine cages. Cost: premium ($300-400/kg raw material vs PEEK unfilled $150/kg).

Workflow: (1) Customer provides patient CT scan. (2) Custom implant designed to patient anatomy. (3) Design approval by treating surgeon. (4) Regulatory submission (FDA 510(k) or CE mark). (5) Manufacture to design. (6) Patient-specific labeling and delivery. We support step 5 (manufacture). Patient-specific medical device manufacturing requires appropriate regulatory pathway — typically customer handles regulatory approval.

Implant sterilization: gamma radiation (standard for Ti, PEEK, 316L), ethylene oxide (EtO), autoclave (limited — not for PEEK implants). Manufacturing parts shipped clean, customer performs final sterilization and packaging per regulatory requirements. We provide ultra-clean parts in particle-controlled packaging suitable for downstream sterilization and packaging.