Class Class II
A.L.P.S. Small Fragment Plating System (K243761)
Description
A.L.P.S. Small Fragment Plating System by Biomet Orthopedics, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243761
Clearance Date2025-02-19
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243761
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. A.L.P.S. Small Fragment Plating System (K243761) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | DePuy Orthopaedics, Inc. | 2012 |
| K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | DePuy Orthopaedics, Inc. | 2009 |
| K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | DePuy Orthopaedics, Inc. | 2007 |
Trace the full predicate network for K243761
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.