FDA-cleared profile
Depuy Ireland UC
Intraoperative X-ray or fluoroscopy software supports total hip arthroplasty with editable machine-learning landmark suggestions and measurements of cup orientation, leg length, offset, and implant constructs.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K253551 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Validate compatible imaging hardware, acquisition geometry, displays, workstation, exported objects, latency, calibration, and fallback workflow.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The surgeon must review and confirm landmarks and remains responsible for implant selection and placement. The software is not for primary image interpretation or mobile-phone use; exact K253551 AI use is Windows-based.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: The surgeon must review and confirm landmarks and remains responsible for implant selection and placement. The software is not for primary image interpretation or mobile-phone use; exact K253551 AI use is Windows-based.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Manufacturer image-analysis, landmark, measurement, workflow, and usability validation · Adult total hip arthroplasty intraoperative radiographic workflows
exact submission · Tested version: VELYS Hip Navigation release cleared in K253551 · Sponsor or vendor studyK253551
Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
This submission was added after the prior exact-submission extraction and remains queued for source review. Exact FDA materials, available current product-family sources, reimbursement context, and exact-identifier postmarket results were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision material, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
Alternatives
OrthoGrid Systems, Inc.
OrthoGrid Hip AI 4.0 analyzes two-dimensional C-arm fluoroscopic images to assist positioning of hip-replacement components during direct-anterior total hip arthroplasty.
Cara Medical, Ltd.
CARA assists adult structural-heart and conduction-system procedure planning by segmenting preprocedural CT, visualizing cardiac chambers and conduction landmarks, and overlaying...
Canon, Inc.
Canon Intelligent NR is a noise-reduction function for fluoroscopic images acquired on compatible Canon radiography and fluoroscopy systems.
Shimadzu Corporation
Trinias is an interventional fluoroscopic X-ray system for diagnostic and interventional angiography, including cardiac, neurovascular, abdominal, peripheral, rotational,...