SMART Osteotomy System— 510(k) K260090
Substantially EquivalentActis Medical Pty., Ltd.
FDA 510(k) clearance K260090 for SMART Osteotomy System, Substantially Equivalent on 2026-04-10. Applicant: Actis Medical Pty., Ltd.. Device class: 2.
Summary
The SMART Osteotomy System is a powered surgical instrument for controlled bone cutting. Product code HRS covers bone saws, burrs, and related orthopedic hardware; the "SMART" naming suggests integrated feedback or torque-monitoring features distinguishing it from purely mechanical osteotomes.
Orthopedic panel, Traditional 510(k). HRS is a high-volume code with a well-characterized predicate set — novel features like force-feedback or connectivity typically warrant specific comparison to the closest predicate with similar capabilities.
Actis Medical Pty. Ltd. files from Torrensville, Australia. Three-month review clock — fast for Traditional 510(k), suggesting a clean predicate comparison.
Clearance details
- Applicant
- Actis Medical Pty., Ltd.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Torrensville, AU
Recent devices under product code HRS
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.