Trauma
Bone screws
- Process
- Swiss + thread whirling
- Material
- Ti-6Al-4V ELI
- Quantities
- 500 to 25,000
Tenth / Medical devices
Implants and instruments
Bone screws, plates, spinal cages and instrument parts, machined in implant-grade material and delivered with records your quality team can audit.
- ISO 13485:2016 certified
- FDA registered
- UDI laser marking
- ISO 7 clean packaging
What we make for medical
From Ø0.5 mm pins to full-size trauma plates, in the materials your device file specifies.
Trauma
Bone plates
- Process
- 3-axis + 3D surfacing
- Material
- Ti-6Al-4V ELI
- Quantities
- 50 to 25,000
Spine
Interbody cages
- Process
- 5-axis milling
- Material
- PEEK, titanium
- Quantities
- 100 to 10,000
Instruments
Jaws and tips
- Process
- Swiss + 4-axis
- Material
- 17-4 PH, 440C
- Quantities
- 1,000 to 20,000
Built for your quality system
Supplier qualification goes faster when the records already match what an auditor asks for.
Validation
- IQ, OQ and PQ support on locked processes
- Capability studies on critical features, Cpk 1.33 or better
- No process change without your written approval
Traceability
- Every lot traced to the bar heat number and mill cert
- UDI and part numbers laser marked in house
- Records packaged for your device history file
Cleanliness
- Multi-stage ultrasonic cleaning after machining
- Passivation of stainless and titanium in house
- Double-bagged in an ISO 7 clean bench
Medical materials
Stocked in bar and plate with certs to the listed standard.
| Material | Standard | Typical use | Finishing |
|---|---|---|---|
| Ti-6Al-4V ELI | ASTM F136 | Screws, plates, cages, spinal rods | Passivate, laser mark |
| CP titanium Gr 2 and 4 | ASTM F67 | Dental and maxillofacial parts | Color anodize (partner) |
| 316L stainless | ASTM F138 | Trauma implants, pins | Passivate, electropolish |
| CoCrMo | ASTM F1537 | Knee and hip components | Polish (partner) |
| PEEK implant grade | ASTM F2026 | Interbody cages, spacers | Clean, laser mark |
| 17-4 PH and 440C | ASTM A564 · A276 | Instrument jaws, drivers, guides | Passivate, laser mark |
Questions medical buyers ask
Can you machine this geometry?
Send the STEP file and drawing. Bone screws with cannulation and variable-pitch threads run on our Swiss lathes with thread whirling. Cages with teeth and graft windows run on 5-axis. You get a written yes or no, with any feature changes we suggest, within 2 business days.
Do you support process validation?
Yes. We write IQ, OQ and PQ protocols for the machining steps, run the studies, and hold the process fixed once you approve it. Any change comes to you first.
Can you laser mark UDI codes?
Yes, in house. We mark GS1 DataMatrix codes, lot numbers and logos on titanium, stainless and PEEK, and verify each code with a grading scanner.
Which finishing do you do in house?
Deburr, ultrasonic cleaning, passivation and laser marking. Color anodize, electropolish on CoCr and coatings go to approved partners that we manage, and their certs ship with your parts.