FDA applicant
Custom Orthopaedic Solutions, Inc.
FDA records 8 decisions for Custom Orthopaedic Solutions, Inc. (Cleveland, OH) from 2013 to 2017: 8 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KWS (Prosthesis, Shoulder, Semi-Constrained…). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Custom Orthopaedic Solutions”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Custom Orthopaedic Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Custom Orthopaedic Solutions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Custom”
FDA records each applicant name separately; these may or may not be the same firm.