Cleared Special

WasherCap™ Fixation System (K250238) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250238 · Abanza Tecnomed S.L · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2025
Decision
29d
Days
Class 2
Risk

K250238 is an FDA 510(k) clearance for the WasherCap™ Fixation System. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Abanza Tecnomed S.L (Mutilva, ES). The FDA issued a Cleared decision on February 25, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abanza Tecnomed S.L devices

Submission Details

510(k) Number K250238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2025
Decision Date February 25, 2025
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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

Precision Life Science Partners
Jessica Czamanski

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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K250238.
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K250424 · Arthrex, Inc. · Mar 2025
SuperBall-RC™
K244015 · Arcuro Medical , Ltd. · Feb 2025
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
K243665 · ZheJiang Decans Medical Devices Co., Ltd. · Jan 2025
WasherCap™ Mini Fixation System (Model 45)
K243712 · Abanza Tecnomed S.L · Jan 2025