Cleared Traditional

SALGINA 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 (K203002) - FDA 510(k) Clearance

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

K203002 · Bonebridge AG · Orthopedic device
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Oct 2021
Decision
369d
Days
Class 2
Risk

K203002 is an FDA 510(k) clearance for the SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle Sy.... 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 October 5, 2021 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bonebridge AG devices

Submission Details

510(k) Number K203002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2020
Decision Date October 05, 2021
Days to Decision 369 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
247d slower than avg
Panel avg: 122d · This submission: 369d
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 Consultant

Meditec Consulting GmbH
Sandra Soniec

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K203002.
CoLink Vallux Plating System
K212487 · In2bones USA, LLC · Nov 2021
Stratum® Ankle Fusion Plating System
K212640 · Nextremity Solutions, Inc. · Nov 2021
LOQTEQ Proximal Humerus Plate 3.5 System
K211582 · Aap Implantate AG · Oct 2021
Anthem Fracture System
K212433 · Globus Medical, Inc. · Oct 2021
GEO Extremity and Ankle Plating System
K212334 · Gramercy Extremity Orthopedics, LLC · Sep 2021
Omni Foot and Ankle Plating System
K212297 · Extremity Medical, LLC · Aug 2021