Cleared Traditional

Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) (K243308) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243308 · Bonebridge AG · Orthopedic device
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Dec 2024
Decision
60d
Days
Class 2
Risk

K243308 is an FDA 510(k) clearance for the Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System,.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Bonebridge AG (Zug, CH). The FDA issued a Cleared decision on December 20, 2024 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bonebridge AG devices

Submission Details

510(k) Number K243308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2024
Decision Date December 20, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K243308.
Versalock Upper Limb Plating System
K243740 · GM Dos Reis Industria e Comercio Ltda. · Jan 2025
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K243569 · TriMed, Inc. · Jan 2025
ARTFX Trauma Bone Plate and Screw System
K242939 · Artfx Medical · Dec 2024
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TDM Plate and Screw System
K241128 · Tdm Co., Ltd. · Dec 2024
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K241995 · Footbridge Medical · Nov 2024