FDA-cleared profile
Disior Ltd
Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and ankle 3D models and measurements for clinician review.
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.
This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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.
Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K223757 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA material describes CT DICOM input, user-assisted segmentation, 3D model generation, and measurements for display or planning.
exact submission · checked 2026-09-04Test 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. Use is limited to CT foot and ankle anatomy and the supported segmentation workflow; user acknowledgment or correction and professional interpretation remain required, and the outputs are not a substitute for complete clinical evaluation.
exact submission · checked 2026-09-04Define 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 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K223757 by exact hardware, software, model, algorithm 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.
exact submission · checked 2026-09-04Revalidate 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.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
Correctly identified foot and ankle bones in 82 CT image series in the FDA test study.
Tested version: Bonelogic 2.2 configuration described in K223757Correctly identified metal in 82 CT image series in the FDA test study.
Tested version: Bonelogic 2.2 configuration described in K223757Sensitivity for metal identification in FDA metal-identification test data.
Tested version: Bonelogic 2.2 configuration described in K223757Specificity for metal identification in FDA metal-identification test data.
Tested version: Bonelogic 2.2 configuration described in K223757FDA 510(k) software verification and clinical-data segmentation study against orthopedic-surgeon reference labels. · 82 test CT image series and development cohorts drawn from 357 studies representing 340 individual patients across U.S. and European sites.
exact submission · Tested version: Bonelogic 2.2 configuration described in K223757 · n=82 · Sponsor or vendor studyK223757
Three orthopedic surgeons provided ground truth; training, tuning, and test data were separated. Metrics are not product-wide diagnostic accuracy.
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, 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 StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
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.
Screened 17 PubMed and one ClinicalTrials.gov record. Bonelogic mentions are versions 1.0, 2.0, 2.1, CMF, developer-level, or unstated rather than the K223757 Bonelogic 2.2 configuration; all 18 were quarantined and none was promoted. The current discovery snapshot contains 17 PubMed and 1 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, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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