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FDA 510(k)

POYA 3.5mm Medial Proximal Tibia System

K-Number: K260228 · 2026-04-24

ApplicantBonebridge AG
Decision Date2026-04-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POYA 3.5mm Medial Proximal Tibia System is a medical device manufactured by Bonebridge AG. It received FDA 510(k) clearance on 2026-04-24 under approval number K260228. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POYA 3.5mm Medial Proximal Tibia System?

POYA 3.5mm Medial Proximal Tibia System is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Bonebridge AG. The 510(k) number is K260228.

When was POYA 3.5mm Medial Proximal Tibia System approved by the FDA?

POYA 3.5mm Medial Proximal Tibia System received FDA 510(k) clearance on 2026-04-24, under approval number K260228.

What company makes POYA 3.5mm Medial Proximal Tibia System?

POYA 3.5mm Medial Proximal Tibia System is manufactured by Bonebridge AG.

What is the FDA product code for POYA 3.5mm Medial Proximal Tibia System?

The FDA product code for POYA 3.5mm Medial Proximal Tibia System is HRS.

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Other Devices by Bonebridge AG

K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System K213864Bonebridge Osteosynthesis Plating System K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) K242399Bonebridge Osteosynthesis Plating System K240318SITTER 3.5mm Versatile System

View all 9 devices →

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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