Cleared Abbreviated

K240461 - OsteoSinter® EVANS and COTTON wedges and related accessories (FDA 510(k) Clearance)

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

K240461 · Ames Medical Prosthetic Solutions, S.A.U. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
294d
Days
Class 2
Risk

K240461 is an FDA 510(k) clearance for the OsteoSinter® EVANS and COTTON wedges and related accessories. Classified as Bone Wedge (product code PLF), Class II - Special Controls.

Submitted by Ames Medical Prosthetic Solutions, S.A.U. (Sant Feliu De Llobregat, ES). The FDA issued a Cleared decision on December 6, 2024 after a review of 294 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ames Medical Prosthetic Solutions, S.A.U. devices

Submission Details

510(k) Number K240461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2024
Decision Date December 06, 2024
Days to Decision 294 days
Submission Type Abbreviated
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
172d slower than avg
Panel avg: 122d · This submission: 294d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PLF Bone Wedge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.
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 - PLF Bone Wedge

All 17
Devices cleared under the same product code (PLF) and FDA review panel - the closest regulatory comparables to K240461.
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K231496 · Paragon 28, Inc. · Aug 2023