Medical CNC Machining & Implantable Parts
From orthopaedic bone screws in TA6V ELI to intervertebral PEEK cages and surgical instruments — precision turned medical components with complete ISO 13485 documentation and lot-by-lot traceability.
Tolerance
±0.003 mm
Materials
TA6V ELI · PEEK · 316L
Quality
ISO 13485
Medical-Grade Materials We Machine
Every material is sourced with full mill certificates and handled under dedicated procedures to prevent cross-contamination. Lot traceability is maintained from raw bar to finished part.
TA6V ELI (Grade 23)
ASTM F136 / ISO 5832-3Orthopaedic bone screws, spinal implants, trauma plates, dental implants. Extra Low Interstitials — maximum biocompatibility for permanent bone contact.
316L Stainless Steel
ASTM F138 / ISO 5832-1Surgical instruments, reusable tools, screws and suture anchors. Excellent corrosion resistance in biological fluids.
Implantable PEEK
ASTM F2026 / ISO 10993Intervertebral cages, craniofacial implants, dental posts. Radiolucent (MRI/CT-scan compatible), modulus close to cortical bone.
Grade 2 CP Titanium
ASTM F67Dental implants, bone anchors, maxillofacial fixation. Best ductility, suitable for cold working.
Medical Parts by Application
Swiss-type sliding-head lathes and 5-axis machining centres allow us to produce the full spectrum of precision medical components — from micro-screws to complex surgical instruments.
Orthopaedics & Trauma
ISO 13485 · ISO 5832-3- Bone screws Ø 2–8 mm (TA6V ELI)
- Cortical and cancellous screws
- K-wires and Steinmann pins
- Tibial nails and intramedullary rods
Spinal Surgery
ISO 13485 · ASTM F2026- Intervertebral PEEK cages
- Pedicle screws in TA6V
- Connecting rods and crosslinks
- Spinal hooks and fixators
Surgical Instruments
ISO 13485- Laparoscopic shafts Ø 3–10 mm
- Bone awls and trocars
- Reusable clamps and retractors
- Cutting guides and surgical templates
Dental & Maxillofacial
ISO 13485 · ISO 6872- Endosseous implants Ø 3–6 mm
- Abutments and prosthetic components
- Osteosynthesis mini-plates
- Surgical fixation screws
ISO 13485 Quality Assurance — Step by Step
Every medical batch is accompanied by a complete Device History Record (DHR). Each step below is documented, archived and available for regulatory audit at any time.
Lot-by-lot material traceability
Every bar of TA6V ELI, 316L or PEEK is received with its AMS/ASTM mill certificate. Lot number is recorded in our ERP and linked to each finished part. Archiving: 15 years minimum.
CMM dimensional report
Full CMM report (ZEISS or equivalent) on all critical dimensions. Balloon-annotated drawing cross-referenced to actual measurement values. Delivered with every batch.
Surface finish verification (Ra)
Ra measured with a calibrated profilometer. Implantable surfaces: Ra < 0.4 µm systematic. Mirror polished surfaces: Ra < 0.1 µm. Profilometer printout included in DHR.
Passivation & biocompatibility
Titanium and 316L parts passivated per ASTM A967 / ISO 16954. Certificate of passivation included. PEEK: no post-treatment required — biocompatibility inherent per ISO 10993.
Device History Record (DHR)
Complete Device History Record per ISO 13485 §7.5.9: drawing revision, material cert, CMM report, Ra measurement, passivation cert. Digitally archived per part number and lot.
Medical CNC Machining — Frequently Asked Questions
Medical CNC Machining — NDA Available
Implantable parts in TA6V ELI, PEEK-OPTIMA™ and 316L with full ISO 13485 documentation. Quote within 48 business hours.