POYA 3.5mm Medial Proximal Tibia System— 510(k) K260228
Substantially EquivalentBonebridge AG
FDA 510(k) clearance K260228 for POYA 3.5mm Medial Proximal Tibia System, Substantially Equivalent on 2026-04-24. Applicant: Bonebridge AG. Device class: 2.
Summary
Bonebridge AG's POYA 3.5mm Medial Proximal Tibia System is filed under product code HRS (Plate, Fixation, Bone).
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Bonebridge filed from Zug, Switzerland. The record shows 88 calendar days from receipt to decision (January 26 to April 24, 2026).
Clearance details
- Applicant
- Bonebridge AG
- Product code
- Product 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
- Zug, CH
Recent devices under product code HRS
view allMore clearances from Bonebridge AG
view all- K261351 — SALGINA 2.5mm Distal Radius System
- K252191 — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
- K250933 — LORRAINE 2.5/3.5mm Distal Humerus System
- K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
- K242399 — Bonebridge Osteosynthesis Plating System
Adverse 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.