Patient-Specific Implants
Weeks, not months.
In-house, start to finish.
A patient-specific implant is tied to one patient and, often, one scheduled surgery. Turnaround is not a preference. It is a clinical necessity.
From talus and ankle components to acetabular cups, unicondylar knees, interbody cages and revision cones, we manufacture to your design in titanium, cobalt chrome and tantalum, and keep every step under one roof. 3D-printing, post-machining, finishing and inspection happen in the same building, on our quality system, with no external queue time and no hand-offs to slow things down.
The result is a finished, inspected implant in your hands in weeks, backed by the documentation your submission needs.
PSI MANUFACTURING
Precision at every step
3D-printing the patient-specific implant is the fast part. The weeks usually disappear into post-processing queues, machining shops and finishing vendors, each one a wait, not work.
At Croom Medical we process every step in the same building on one quality system, there is no external queue to sit in. That is how a finished, inspected implant reaches you in weeks, not months.
Dedicated L-PBF Platforms
Validated L-PBF processing Ti-6Al-4V Grade 23 and cobalt chrome, with tantalum capability via TALOS™. Each material runs in its own segregated environment.
Targeted Lattice Application
Our engineers configure and apply interconnected lattice structures directly to your implant geometry. Tunable porosity and configurable pore size, optimized to the target anatomy and fixation requirements.
CNC Machining & Finishing
CNC machining, grinding, polishing and anodizing, all on-site. Tight-tolerance machining on critical interfaces, mirror-finish polishing on articulating surfaces, and passivation per ASTM F86.
In-House Testing & Inspection
Mechanical, chemical, morphological and dimensional testing completed under one roof, to recognized ASTM methods. Full traceability from powder lot to finished implant, with no outsourcing and no gaps in the evidence chain.
Regulatory Support Documentation
Process validation records, material certifications, mechanical test data and build reports, all provided as standard. Your regulatory and quality teams get the evidence package they need to support a 510(k)/PMA or MDR technical file.
Single-Source Supply
One partner from your design to the packaged implant, with an EU base that gives US OEMs a dual-source option and European OEMs a partner on their doorstep. Capacity available now and growing with ACOT.
BIOFUSE 3D-PRINTED LATTICE
Lattice engineered for the anatomy.
Optimal bone ingrowth depends on precise lattice architecture. Pore size, porosity, strut geometry and interconnectivity all shape how bone responds to an implant surface.
Biofuse™ gives our engineers the tools to tune each of those variables to the demands of the specific implant and the target anatomy. Dense and porous regions are produced in a single L-PBF run, fully interconnected and inseparable from the implant itself.
- Interconnected porosity: 50–80% (tunable)
- Pore size: 100–600 µm (configurable)
- Strut architectures: Diamond, gyroid, and TPMS topologies
- ASTM F1854 compliant
- Applications: talus ankle, unicondylar knees, acetabular cups, interbody cages, femoral components, revision cones
proven at scale
The quality systems behind PSI run at volume every day.
PSI at Croom Medical runs on the same processes, certifications and quality culture we use to deliver implants at production scale. The discipline we apply to a one-off patient-specific component is the discipline we apply to a 250,000-unit knee program.
- 40 years manufacturing complex orthopedic implants since 1984.60,000+ additive-manufactured implants produced to date.250,000+ Knee systems manufactured every year.
- 3.5 million+ Femorals manufactured to date.
- ISO 13485:2016. Certified quality system. FDA registered facility.
- Published research across Materials Science & Engineering A, Additive Manufacturing, and the Journal of Applied Physics.
Our Facility
The scale to consistently deliver
24/7 Production
A growing team of 150+ product builders, engineers and professionals delivering top quality, reliable medical devices.
Certified
Certified to ISO 13485 and 14001 standards. FDA registered facility
Latest, Cutting-Edge Equipment
More than €12M invested in plant & machinery over the past 4 years to advance our capabilities.
On-Site RD&I Lab
We operate our own on-site R&D and materials testing lab for tensile, compression and fatigue testing.
Labour Knowledge & Skills
Situated in Limerick, the centre of Ireland’s MedTech manufacturing cluster with a wealth of labour knowledge and skills in orthopedic manufacturing.
Quality-At-Scale
Producing quality at volume, with 3.5M+ femorals manufactured to date. And we’re growing, with floor space increasing by more than 10,000 sq. feet in 2024.
DEVICES
Extend capacity & advance quality
Tap into our passion for innovation and we’ll help advance quality, extend your capacity and accelerate time to market.
Knee Implants
Femoral implants, patella and tibia implants, and limb salvage.
Hip Implants
Hip stems, acetabular cups, femoral heads and femoral liners.
Spine Implants
Interbody cages, pedicle screws and rods, and SI fixation screws.
Trauma & Extremities
Shoulder & elbow, foot & ankle, tibia & femur, hand & wrist, cranial & maxofacial.
Capabilities
Joint Partnership
We help drive progress for our medical device customers by enhancing both their production capacity and their product and process innovation.
Manufacturing Capabilities
The facilities, technologies and processes to deliver end-to-end manufacturing.
Value-Add Capabilities
The team, expertise, and ingenuity to drive tangible added-value for our customers.
Ready to move your PSI program forward?
Tell us about your device and your timeline, and we’ll show you how fast in-house manufacturing can move. Your design, your IP, your regulatory authority. Our process, our evidence package, and a finished implant in weeks, not months.