Class Class II
OIC Small / Mini Fragment Plate System (K242995)
Description
OIC Small / Mini Fragment Plate System by The Orthopaedic Implant Company, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242995
Clearance Date2024-10-23
Clearance TypeSpecial
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242995
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. OIC Small / Mini Fragment Plate System (K242995) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | Orthopaedic Implant Company | 2023 |
| K171904 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2018 |
| K140814 | EVOS MINI-FRAGMENT PLATING SYSTEM | Smith & Nephew, Inc. | 2014 |
| K113760 | VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE... | Howmedica Osteonics Corp., Dba Stry... | 2012 |
| K090047 | SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM | Synthes (Usa) | 2009 |
Trace the full predicate network for K242995
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.