Some cases are straightforward. Many are not. When standard devices do not address the complex anatomy of your patient — significant bone loss, a failed revision, or oncologic reconstruction — you need a highly competent manufacturing partner with the orthopedic design and engineering skills to deliver.
This product is a custom device made to meet the specific needs of an individual patient or physician. It is not generally available and is subject to the FDA's Custom Device Exemption under Section 520(b) of the FD&C Act. This product is for prescription use only. This is not a substitute for standard medical devices and should be used only as directed by a qualified healthcare provider. Use is restricted to sale by or on the order of a physician. This device is a custom device and is subject to FDA Custom Device Exemption regulations.
ALM Ortho's Implant as a Service® model covers every step. You focus on your patient. We engineer the solution.
Patient CT scans inform anatomy. A 3D model is created for planning and collaborative review with the surgeon.
Using patient imaging data, engineers create a 3D anatomy model and develop a device specific to that patient. Design is reviewed collaboratively with the surgeon prior to release for manufacturing.
Approved designs are built on our GE Additive Arcam Q10plus EBM platform using medical-grade titanium (Ti-6Al-4V ELI). Secondary processes include machining, TiN coating, and sequential quality assurance.
Patient-matched device(s), system components, and instrumentation are packaged and shipped to the facility for surgery.
Where required, ALM Ortho designs and provides patient-matched instruments to complement the device.
Detailed technique documentation is provided for every custom and patient-matched device, including device orientation, fixation sequence, and intraoperative handling instructions.
Our engineering team is available for preoperative case reviews, including 3D model walkthroughs and virtual surgical planning sessions when case complexity warrants it.
Whether you have a challenging case or want to explore what a partnership with ALM Ortho could offer your practice or institution — we want to hear from you.— ALM Ortho Team · info@almortho.com · (207) 613-0333
