Orthopedic instrument and implant component manufacturing
Bone screws, baseplates, knee system components, instrumentation, positioning systems, reamers and drivers for knee, trauma, spine, sports medicine and CMF programs. Swiss-type turning, 5-axis milling, EDM, passivation and UDI laser marking under ISO 13485 in the U.S.
UTP Solutions manufactures orthopedic implant components and surgical instruments to your print, under an ISO 13485, FDA-registered quality system. We produce cannulated, cancellous, cortical, pedicle and bioabsorbable bone screws, baseplates and knee system components, instrumentation and positioning systems, and instruments such as drills, taps, reamers, drivers, inserters, guides and broaches, for knee, trauma, spine, sports medicine and CMF systems. Small turned parts run complete on our Tsugami Swiss-type lathe up to 20 mm diameter. Complex multi-face parts run on 3-, 4- and 5-axis machining centers, with wire and sinker EDM for sharp internal corners and fine features. We hold ±0.0005" on most milled features, down to ±0.0001" on select features, grind to ±0.0001", and verify on CMM. We support first articles through production volumes, with no minimum order.
What we make for orthopedic programs
Bone screws
Cannulated, cancellous, cortical, pedicle and bioabsorbable bone screws, with threads, drive features and cannulation produced complete on the Swiss.
Baseplates, knee components and glide surfaces
Baseplates, knee system components and implant glide surfaces with multi-face geometry, machined on 5-axis centers and verified on CMM.
Surgical instruments
Drills, taps, reamers, drivers, inserters, guides and broaches in stainless steel, titanium and PEEK. Trials, rasps and awls are also within our machining capability.
Trauma and PEEK plates
Machining capability for trauma plates and PEEK plates, with the same qualification, inspection and finishing approach as our screws and instruments.
Instrumentation and positioning systems
Instrumentation and positioning system components where machined metal, molded polymer and assembly come together under one roof.
Overmolded instrument handles
PPSU and other thermoplastic handles overmolded in-house onto machined instrument shafts, so one supplier owns both the metal and the molding. Silicone overmolding is available through a qualified partner.
You own the device design and its regulatory clearance. UTP manufactures to your specification and supports the inspection, qualification and validation records your quality system requires.
Orthopedic systems we support
Processes and specifications
| Swiss-type CNC turning | Tsugami S206-II · up to 20 mm turned diameter · turn, mill, drill and thread in one cycle |
|---|---|
| Multi-axis milling | 3-, 4- and 5-axis machining for complex geometries in fewer setups |
| EDM | Wire and sinker EDM (Sodick) plus EDM drilling for internal corners, slots and fine features without tool pressure |
| Grinding | Surface, cylindrical and centerless grinding · ±0.0001" consistently |
| Tolerances | Milling ±0.0005" on most features, down to ±0.0001" on select features · confirmed per feature during DFM |
| Materials | Titanium Grade 2 (CP, ASTM F67), Grade 5 (Ti-6Al-4V) and Grade 23 (Ti-6Al-4V ELI, ASTM F136) · stainless steel including 316L (ASTM F138) and 17-4 PH · PEEK · Inconel 625/718. Material certifications tracked to lot. |
| In-house finishing | Precision cleaning · citric or nitric passivation · UDI and part-identification laser marking · bead blasting, sand blasting and aluminum oxide blasting |
| Managed finishing | Heat treat, polishing, anodizing and color anodizing, electropolishing, TiN/PVD coating and silicone overmolding through qualified suppliers, coordinated by UTP so you get finished parts from one source |
| Packaging | Pouch sealing · packaging · kitting |
| Metrology | Onsite QC laboratory with equipment including two CMMs measuring features to 0.0001", a Keyence vision measurement system and a profilometer for surface finish · first article inspection · MSA including Gage R&R · capability studies |
| Volume | First article through production · no minimum order quantity |
| Quality system | ISO 13485 · FDA registered · ISO 9001 · lot traceability and change control |
How we qualify a machining process
Machined dimensions can be measured directly, so a machining process is qualified and then verified by inspection. Full IQ/OQ/PQ is reserved for processes where the result can't be fully measured on the finished part, such as those that change material properties or surface condition.
- Equipment qualification for the machines and inspection equipment used on the part
- CNC program and setup qualification so the same program, workholding and tooling produce the same part every run
- Tool-wear and tool-life studies that set tool change intervals before wear moves a critical dimension or finish
- Surface finish verification with our in-house profilometer on the features where finish affects function or cleanability
- Material verification, with certifications tracked to lot and property testing where the program requires it
- Measurement system analysis (MSA), including Gage R&R, so inspection results on critical features can be trusted
- Capability studies on critical-to-quality features to show the process holds tolerance run after run
- First article inspection on the production process, then in-process and final inspection on our two CMMs and Keyence vision system
- Validated special processes: cleaning, citric or nitric passivation and laser marking are performed and validated in-house, because their results can't be fully verified by inspection
- Qualified finishing suppliers for heat treat, polishing, anodizing, electropolishing and TiN/PVD coating, managed under UTP's supplier controls
Swiss turning or 5-axis milling?
Long, slender parts with diameters up to 20 mm, such as pins, screws and instrument shafts, usually belong on the Swiss. The guide bushing supports the bar right at the cut, which holds concentricity on parts a conventional lathe would push away. Parts with features on many faces, such as instrument tips, connectors and housings, usually belong on a 5-axis machining center, which reaches those faces in one or two setups. Many orthopedic parts use both, plus EDM for the internal features neither can cut. Because all three run in the same building, an engineer can pick the route for each feature instead of forcing the part onto one machine.
How a program runs
DFM review
An engineer reviews the print, material and critical features, and tells you which tolerances drive cost and risk before you commit.
First article
Parts machined on the production process, with a full dimensional first article inspection report.
Process qualification
Equipment, CNC program and setup qualification, tool-wear and tool-life studies, surface finish verification, MSA with Gage R&R, and capability studies, documented to your quality agreement.
Production and supply
Lot traceability, material certifications and inventory programs so instrument sets and implant builds aren't waiting on parts.
Orthopedic manufacturing questions
What orthopedic implants and instruments does UTP manufacture?
UTP manufactures cannulated, cancellous, cortical, pedicle and bioabsorbable bone screws, baseplates, knee system components, implant glide surfaces, instrumentation, positioning systems, and instruments including drills, taps, reamers, drivers, inserters, guides and broaches, for knee, trauma, spine, sports medicine and CMF systems.
Can you laser mark UDIs?
Yes. We apply UDI and part-identification laser marking in-house as a validated process.
Does UTP machine titanium implant components?
Yes. We machine titanium Grade 2 (CP, ASTM F67), Grade 5 (Ti-6Al-4V) and Grade 23 (Ti-6Al-4V ELI, ASTM F136) to the customer's print and material specification, with material certifications tracked to each lot and CMM inspection in our onsite lab.
Do you machine 316L implant-grade stainless steel?
Yes. We machine 316L to ASTM F138 and 17-4 PH stainless for implant components and instruments, with material certifications tracked to each lot.
What is the largest diameter your Swiss lathe can turn?
Our Tsugami S206-II Swiss-type lathe turns parts up to 20 mm in diameter.
Can you machine PEEK instrument and implant parts?
Yes. We machine PEEK and also mold it, so PEEK parts can be machined, molded, or both, depending on volume and geometry.
What tolerances do you hold on orthopedic parts?
±0.0005" on most milled features, down to ±0.0001" on select features, and ±0.0001" on ground features. We confirm each critical feature during DFM.
Do you support prototype and low-volume orthopedic programs?
Yes. We machine from a single first article through production volumes, with no minimum order.
Do you validate machining processes with IQ/OQ/PQ?
Machined dimensions can be fully measured, so we qualify the machining process instead: equipment, CNC programs and setups, tool-wear and tool-life studies, surface finish and material verification, MSA including Gage R&R, and capability studies, then first article and ongoing inspection. Full IQ/OQ/PQ applies to processes whose results can't be fully verified on the finished part, such as those that affect material properties.
Do you passivate and laser mark orthopedic parts in-house?
Yes. We clean, passivate (citric or nitric) and laser mark in-house as validated processes, and bead blast, sand blast and aluminum oxide blast in-house. Heat treat, polishing, color anodizing, electropolishing and TiN/PVD coating are performed by qualified suppliers, and UTP manages them so finished parts ship from one source.
Can you overmold instrument handles?
Yes. We overmold PPSU and other thermoplastic handles in-house onto machined instrument shafts. Silicone overmolding is available through a qualified partner, managed by UTP.
Do you package and kit orthopedic components?
Yes. We offer pouch sealing, packaging and kitting, and coordinate sterilization through qualified providers.
Are you ISO 13485 certified and FDA registered?
Yes. UTP is ISO 13485 certified and FDA registered, and also holds ISO 9001 and IATF 16949 certification.
Talk to an engineer, not a call center.
Send the drawing, material and quantity. A UTP engineer replies within two business days with feasibility, the machining route, and a path to first article.