510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240461Substantially Equivalent

OsteoSinter® EVANS and COTTON wedges and related accessories

Ames Medical Prosthetic Solutions, S.A.U., Sant Feliu De Llobregat, ES / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240461 is the FDA 510(k) clearance record for OsteoSinter® EVANS and COTTON wedges and related accessories, a class II device, cleared for Ames Medical Prosthetic Solutions, S.A.U. on under FDA product code PLF (Bone Wedge). FDA's definition for product code PLF reads: "Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia". FDA records list one 510(k) clearance for Ames Medical Prosthetic Solutions, S.A.U. As of , FDA records show no recalls naming K240461.

Clearance record

Decision date
Received
(294 days to decision)
Product code
PLF Bone Wedge
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Ames Medical Prosthetic Solutions, S.A.U. Ctra. Laurea Miro 388, Sant Feliu De Llobregat, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLF

Trailing 12 months
1 clearance under product code PLF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PLF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260