HRX-MD-02 · Medical Device Parts

Surgical & Orthopaedic Components — Medical Device Parts

Name: Surgical & Orthopaedic Components
Brand: HRX MACHINING
SKU: HRX-MD-02
Availability: MadeToOrder

Instrument bodies, bone plates, drill guides and implant trial components.

Tolerance±0.02 mm

MOQ20 pcs

Lead time15–22 days

AvailabilityMade to order

Part type

Material

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Applications

Orthopaedic trauma systems
Spinal surgery instruments
Dental and maxillofacial
Reusable surgical instruments

Surgical instruments and orthopaedic components carry two requirements at once: the geometry has to be exactly right, and the surface has to be cleanable and traceable. We machine instrument bodies, bone plates, drill guides, trial implants and trial sizers in stainless and titanium, with every part identified by a laser-marked lot code so a batch can be traced back to its raw material. Surfaces are electropolished or passivated to resist repeated sterilisation cycles.

Specifications

Material: Stainless 316L / 420, Ti-6Al-4V ELI, Al 7075
Dimensions: per drawing, up to 250 mm
Tolerance: ±0.02 mm (±0.01 on critical)
Surface roughness: Ra 0.4 – 0.8 µm
Flatness: 0.03 mm on plate contact faces
Sterilisation: Autoclave 134 °C, > 1000 cycles
Biocompatibility: ISO 10993 material cert. available
Machine: 3–5 axis CNC milling + turning
Surface finish: Electropolished / passivated / blasted
Certificates: EN 10204 3.1, RoHS on request
MOQ: 20 pieces
Lead time: 15–22 working days

Key features

Laser-marked lot code on every part
Withstands repeated sterilisation cycles
Traceability back to raw material batch
Electropolished or passivated surface
Trial sets for design validation

Scope of delivery

Clean-room packed, individually bagged
Lot code laser-marked
Material certificate + report

Quality control

Every batch is checked on a coordinate measuring machine, with calipers, micrometers and gauge blocks on the shop floor. A dimensional report is available with each shipment and first-article inspection is free on series orders.

Competitive advantages

vs. Cast bone plates / implant trials: CNC 316L / Ti-6Al-4V ELI with laser lot codes: no cast porosity, sterilisation-cycle proof, traceable
vs. Off-the-shelf reusable instruments: Custom geometry to your system; trial sizers and jigs matched to your implant, not a generic catalogue
vs. Injection-moulded plastic parts: Metal instrument bodies and drill guides with stiffness and edge retention plastic cannot reach
vs. Low-cost uncertified CNC shops: EN 10204 3.1, RoHS and ISO 13485 documented process so a medical buyer can clear a supplier audit

Frequently asked questions

How long does a quote take, and what about lead time?

Quotes are returned within 24 working hours, usually the same day for simple parts. Production lead time is typically 7–20 working days depending on complexity, material availability and finishing.

Can you work without a drawing?

Yes. Send a sample part and we will measure it and produce a drawing for your approval before machining. This is common for replacement parts and legacy equipment where no drawing exists.

What materials and finishes are available?

Aluminium 6061/7075/6063, stainless 303/304/316L, carbon steel, brass, copper C1100, titanium Ti-6Al-4V and engineering plastics such as POM and PEEK. For medical parts we can supply EN 10204 3.1 certificates and ISO 10993 compliant materials. Finishes include anodising (Type II and III), nickel plating, sandblasting, passivation, electropolishing and knurling.