Authorized purpose: Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Foot/Ankle Input: Eligible CT image series of the foot and ankle meeting labeled acquisition and quality requirements.
Who uses it?Intended users: Qualified orthopaedic professionals.
What does the software produce?Output: Three-dimensional models, measurements, metal-detection results, and planning parameters for professional review.
What is its most important limitation?Key limitation: Outputs support professional planning and do not prescribe the surgical procedure; users must review measurements and apply clinical judgment.
Clinical takeaway
Clinical role: Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
Evidence takeaway
Evidence from the reviewed source record: 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.
Clinical details
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.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
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.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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 ยท 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. Candidate literature without exact product and version linkage is not shown as product evidence.
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.
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.
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
2026-09-20Last searched
21Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
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
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history7 sources - 3 history items
Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and...
Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...