APTUS FOOT SYSTEM— 510(k) K091479
Substantially EquivalentMedartis AG
FDA 510(k) clearance K091479 for APTUS FOOT SYSTEM, Substantially Equivalent on 2009-07-13. Applicant: Medartis AG. Device class: 2.
Clearance details
- Applicant
- Medartis AG
- 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
- San Diego, CA, US
Recent devices under product code HRS
view allMore clearances from Medartis AG
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 →
Recalls naming K091479
K-number listed on FDA's recall record- Z-1550-2026 — Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
- Z-1821-2024 — APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091479.
Data sourced from openFDA. This site is unofficial and independent of the FDA.