# Custom Orthopaedic Solutions, Inc.

- Location (FDA's records): Cleveland, OH
- FDA decisions: 8 (2013–2017): 8 510(k) clearances
- Names in FDA's records: Custom Orthopaedic Solutions, Inc. (6); Custom Orthopaedic Solutions (2)
- Product codes: LLZ (4), KWS (4)
- 510(k) review time since 2016: median 106 days, against 114 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 14 (11 its own); citations of its devices by later devices: 14 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cleveland Clinic: 2 (https://510kreport.com/company/cleveland-clinic)
- Materialise NV: 1 (https://510kreport.com/company/materialise)

## Firms that cite its devices most
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Blue Ortho: 1 (https://510kreport.com/company/blue-ortho)

## Its most-cited devices
- K142072: Glenoid Intelligent Reusable Instrument System (Glenoid Iris) (2014), cited by 3
- K133367: Orthovis Preoperative Plan (2013), cited by 3
- K151568: Arthrex OrthoVis Preoperative Plan (2015), cited by 2
- K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (2015), cited by 2
- K151501: OrthoVis Web Portal (2015), cited by 2
- K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal (2017), cited by 2

## Recent decisions
- K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal (Feb 10, 2017)
- K153612: ArthrexVIP Web Portal (Mar 15, 2016)
- K153215: SmartBase for Arthrex Glenoid IRIS (Feb 19, 2016)
- K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (Oct 5, 2015)
- K151501: OrthoVis Web Portal (Oct 2, 2015)
- K151568: Arthrex OrthoVis Preoperative Plan (Jul 31, 2015)
- K142072: Glenoid Intelligent Reusable Instrument System (Glenoid Iris) (Nov 24, 2014)
- K133367: Orthovis Preoperative Plan (Dec 20, 2013)

Source page: https://510kreport.com/company/custom-orthopaedic-solutions