Cleared Traditional

SITTER 3.5mm Versatile System (K240318) - FDA 510(k) Clearance

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

K240318 · Bonebridge AG · Orthopedic device
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Aug 2024
Decision
203d
Days
Class 2
Risk

K240318 is an FDA 510(k) clearance for the SITTER 3.5mm Versatile 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 August 23, 2024 after a review of 203 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 K240318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date August 23, 2024
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K240318.
Fine Osteotomy™
K241356 · Bodycad Laboratories, Inc. · Sep 2024
EVOS Patella Plates
K240487 · Smith & Nephew · Sep 2024
REDEMPTION Charcot Plating System
K233816 · Vilex, LLC · Aug 2024
RibFix Titan™ Fixation System
K241282 · Riverpoint Medical · Aug 2024
NCB® Polyaxial Locking Plate System
K241754 · Zimmer Switzerland Manufacturing GmbH · Aug 2024
CoLink NeoFuse MIS Plating System (see attached parts list)
K241387 · In2bones USA · Aug 2024