Patient-specific orthopedic care uses a patient’s imaging and a surgeon’s plan to create an anatomical model, a surgical guide or instrument, or an implant designed for a particular case. It can help address unusual anatomy, bone loss, tumor-related defects, and complex fractures—but customization is not automatically more accurate, faster in the operating room, or better for every patient.
“Speed” is an industry priority that usually concerns design, manufacturing, and delivery. Whether a custom device shortens an operation is a separate clinical question, and the evidence depends on the procedure and device.
What does patient-specific orthopedics include?
The process generally starts with patient imaging. The anatomy is reconstructed from those images, then a surgeon and engineering team can use the model to plan a procedure and design a device for the case. The output may be a model used for planning, a temporary guide, or a permanent implant. These are different products with different roles and requirements.
| Approach | What it does | What to consider |
|---|---|---|
| Imaging-derived anatomical model | Represents the patient’s anatomy for planning or visualization; it is not itself a guide or implant. | Its usefulness depends on the quality of the imaging reconstruction and how the clinical team uses it. |
| Patient-specific instrumentation (PSI) | A temporary guide or instrument intended to help reproduce a planned cut, drill trajectory, or placement. | It must seat correctly on the intended bone surface. A misplaced guide can translate into a plan error, and some PSI approaches lack navigation-style intraoperative image feedback. |
| Custom implant | A device designed to remain in the body and address a particular anatomical or reconstructive need. | In addition to fit, it must meet the relevant material, mechanical, and biological demands. |
That distinction matters: evidence about a guide for one operation does not establish the benefits or risks of a custom implant, and a printed model is not an implanted device.
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When might a custom device make sense?
The strongest rationale is a case in which standard devices may not match the anatomy or the reconstructive problem—for example, substantial bone loss, a tumor-related defect, an unusual anatomical shape, or a complex fracture. A patient-specific design may give the clinical team another way to plan or reconstruct a difficult case. It is not a default upgrade for routine orthopedic surgery.
The relevant comparison is not simply “custom” versus “standard.” It is whether a particular model, guide, or implant addresses a specific problem well enough to justify the imaging, planning, manufacturing, validation, delivery, safety, and cost demands involved.
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Can a custom orthopedic device make surgery faster?
Not necessarily. An industry can aim to speed up design and delivery without proving that a device reduces time in the operating room. The full workflow includes imaging and segmentation, surgeon review, engineering design, manufacture, quality checks, and delivery. A delay or rework at any of those stages can affect when the device is ready. No comparable vendor turnaround times or prices are established here, so a general delivery promise or cost comparison would be misleading.
For total knee arthroplasty (TKA), a 2025 Cureus systematic review and meta-analysis of 14 comparative studies covering 2,704 procedures reported improved pooled alignment measures with PSI, but no statistically significant difference in operation time. The authors also reported high heterogeneity, meaning the studies’ results varied substantially. Those findings concern PSI in TKA; they do not establish that custom implants, tumor reconstructions, spine procedures, or other operations will be faster or more accurate.
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What does the evidence establish—and what remains uncertain?
McAnena, McClennen, and Zheng’s 2025 review selected 58 papers on 3D-printed orthopedic implants and surgical devices. It describes promising uses, but the evidence base is not strong enough to support broad claims of superiority: only five included papers had more than 20 participants, and many reported cases lacked a conventional-device control group. Favorable results in selected cases show that a technique can be used; by themselves, they do not prove it outperforms standard care.
- In that review, 48% of the included papers involved orthopedic oncology. This describes the review’s literature sample, not the share of orthopedic patients with cancer or bone defects.
- Among the 47 reviewed implant articles, 81% used titanium alloy. That is a proportion of those articles, not a market-share estimate or a recommendation for an individual patient.
- The review calls for large controlled studies and longer safety follow-up to compare patient-specific implants with standard care and assess safety over time.
The history of PSI also cautions against treating a promising concept as settled practice. A 2018 review of patient-specific applications in orthopedics discussed image-registration and guide-fit limitations, including the absence of navigation-style intraoperative image feedback as a constraint. Earlier meta-analyses discussed in that review did not support routine PSI in TKA. A later 2025 TKA meta-analysis reported improved pooled alignment measures, but found no significant operation-time difference and high heterogeneity. These findings address particular interventions, outcomes, and evidence sets; they are not proof of a single answer for all procedures.
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For context, a 2013 survey by Thienpont reported 82,556 PSI TKA cases worldwide in 2012, based on volumes reported by manufacturers contacted for the survey. That is a historical, survey-scoped figure—not a current estimate of use.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Why can precision fail between the scan and the operation?
A custom design is only as dependable as the workflow that turns anatomy into a device and then into correct use in surgery. Image segmentation must represent the relevant anatomy accurately. For PSI, the guide’s footprint and contact with the bone matter: if it does not seat as intended, the planned cut or trajectory may not be reproduced. A plan can therefore be precise on screen yet fail at the point of use.
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Surgeons and device teams also need to consider how the placement will be checked during the operation. A guide does not necessarily provide the live image feedback associated with navigation systems. For an implant, fit is only one part of the question; the device must also be suitable for its intended mechanical and biological role. These are reasons to assess the complete process, not assume that patient-specific design guarantees precision.
What does “speed alongside precision” mean for OrthoMatrix?
A September 30, 2026 Digital Journal article describes Ortho Solutions Group and its OrthoMatrix platform in connection with patient-specific fusion cages and total talus implants for significant foot-and-ankle bone loss. It attributes the phrase “The disruption will be speed to delivery” to Kevin Brothen, U.S. President at Ortho Solutions, and also quotes him saying, “Every patient is different, so one standardized solution cannot necessarily serve everyone.” Those comments are an industry executive’s perspective on delivery and customization, not independent comparative evidence that a particular product improves outcomes or shortens surgery.
The practical meaning of speed is a delivery challenge: a device must be planned, manufactured, checked, and available when the clinical team needs it. The information available here does not establish a product-specific delivery time, price, regulatory status, or independent comparison with standard treatment.
What should patients and clinical teams compare?
A useful discussion starts with the exact problem and the exact device—not with the general promise of customization. Questions to resolve include:
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- Indication: What anatomical or reconstructive problem is the device meant to address, and why might a standard option be unsuitable?
- Device type: Is the proposal an anatomical model, temporary guide or instrument, or permanent implant?
- Procedure-specific evidence: What studies evaluate this type of device for this operation, and do they measure outcomes that matter for the case?
- Planning and approval: How will imaging be processed, who reviews the plan, and how are changes or errors handled before manufacture?
- Fit and verification: How will correct seating or implant placement be assessed, and what is the plan if the device does not fit as intended?
- Timing and contingency: What is the expected manufacturing and delivery schedule for this case, and what happens if the device is delayed or cannot be used?
- Safety and quality: What quality controls and applicable regulatory requirements govern the specific device in the relevant geography? Requirements are geography- and device-specific; the general discussion in a 2025 review is not a substitute for current official regulatory guidance.
- Total cost: What costs are attributable to imaging, planning, manufacture, and the procedure, and how do they compare with the clinically appropriate alternative?
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