Cleared Traditional

Bonebridge Osteosynthesis Plating System (K213864) - FDA 510(k) Clearance

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

K213864 · Bonebridge AG · Orthopedic device
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Sep 2022
Decision
266d
Days
Class 2
Risk

K213864 is an FDA 510(k) clearance for the Bonebridge Osteosynthesis Plating 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 September 2, 2022 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 K213864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2021
Decision Date September 02, 2022
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 K213864.
Arthrex 3.5 mm Locking Compression Plates
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DePuy Synthes 3.5mm Intrapelvic Acetabular System
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I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
K210935 · I.T.S. GmbH · Aug 2022
ARIX Small Fragment System
K221920 · Jeil Medical Corporation · Aug 2022
Baby Gorilla®/Gorilla® Plating System
K222194 · Paragon 28, Inc. · Aug 2022