Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
FDA source Exact FDA submission Checked 2026-09-08
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K240642
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact FDA summary establishes CT image-series processing and a software planning workflow; exact hosting and PACS or EHR interfaces require vendor confirmation.
FDA source Exact FDA submission Checked 2026-09-08
Public source Exact FDA submission Checked 2026-08-13
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Vendor confirmation Exact FDA submission Checked 2026-09-08
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-08
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-08
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Current product-family workflow context
Paragon 28 publishes a current-family IFU describing foot and ankle measurement and surgical-planning workflows and their visualization-only boundaries.
product family · checked 2026-09-08
Confirm exact-release availability, interfaces, hosting, security, support, and commercial terms during procurement.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
FDA-described testing used 82 CT image series. Foot and ankle bones were correctly identified in all test series; metal presence detection was reported with 100% sensitivity and 98% specificity. The summary states that component testing met the predetermined acceptance criteria and that clinical data were not needed for the substantial-equivalence determination.
FDA source Exact FDA submission Checked 2026-09-08
Nonclinical component testing of bone identification, metal identification, segmentation, measurements, and surgical-planning calculations. · 82 CT image series in the held-out component test set; the FDA summary states that clinical data were not required.
exact submission · Tested version: SMART Bun-Yo-Matic CT configuration submitted in K240642 · n=82 · Sponsor or vendor study
K240642
FDA submission evidence; component metrics are not diagnostic accuracy for a disease endpoint.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-08
No public price or quote for the exact K240642 configuration was established in this review.
Reimbursement and coding
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-08
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K240642. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Public source Exact FDA submission Checked 2026-09-08
Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
Verify pricing and total cost: No public price or quote for the exact K240642 configuration was established in this review.
Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-08Last searched
20Fields reviewed
9Source classes checked
0Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA scope controls clinical claims. ACR and official vendor material provide bounded catalog or product-family context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 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 summary, vendor instructions for use, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
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