Industry · Medical Implants

Spine cages.
Cranial plates.
Dental implants.

CNC manufacturing for medical implant applications. Ti-6Al-4V ELI (ASTM F136), PEEK-OPTIMA (Invibio), CoCr (ASTM F75), 316L (ASTM F138). Spine cages, cranial reconstruction, orthopedic hardware, dental implants. ISO 13485-compatible documentation.

Medical Implants Quote Medical CNC (general)

Ti Gr.23 ELI PEEK-OPTIMA ISO 13485 docs Full traceability

01 · Implant material options

Implantable-grade materials.

Permanent implants require specific certified materials. These are the industry-standard implant-grade materials we work with.

Ti-6Al-4V ELI (Gr.23)

ASTM F136 · Implantable

Extra-low-interstitial titanium — the orthopedic and dental implant standard. Lower iron/oxygen for better fracture toughness.

PEEK-OPTIMA

Invibio · Implantable

Premium medical PEEK grade. Spine cages (best application), orthopedic hardware. Bone-like modulus reduces stress shielding.

CoCr ASTM F75

Cast cobalt-chromium

Cast cobalt-chromium for joint replacement articulating surfaces. High wear resistance.

CoCr ASTM F799

Wrought cobalt-chromium

Wrought CoCr for bone plates, spinal rods, structural implants. Higher strength than cast.

316L ASTM F138

Implantable stainless

Medical-grade stainless for temporary implants, surgical instruments, fracture fixation.

Pure Titanium Gr.2

ASTM F67

Commercially pure titanium for dental implants and specialty orthopedic. Excellent osseointegration.

Pure Titanium Gr.4

ASTM F67

Higher-strength CP titanium. Dental implants requiring higher mechanical performance.

Tantalum

ASTM F560

Porous tantalum for bone ingrowth structures. Trabecular metal substitute.

02 · Implant applications

Medical implant categories.

Spine cages

PEEK-OPTIMA or Ti cervical, thoracic, lumbar spine fusion cages

Cranial plates

Titanium cranial reconstruction plates, skull repair hardware

Dental implants

Titanium dental implants — root form, healing abutments, crown abutments

Orthopedic bone plates

Titanium fracture fixation plates — various anatomical locations

Trauma hardware

Bone screws, pins, nails, external fixation components

Joint replacement

Hip, knee, shoulder replacement components — femoral stems, tibial baseplates, acetabular cups

Osteotomy wedges

Custom osteotomy wedges for bone reconstruction surgery

Spinal rods

Posterior spinal instrumentation — rods, hooks, screws

Custom patient-specific

Patient-specific implants from CT imaging — cranial, maxillofacial, orthopedic

FAQ

Medical Implants questions.

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.