Class Class II
OLYMPIC Deformity Band System (K222097)
Description
OLYMPIC Deformity Band System by Astura Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222097
Clearance Date2023-05-04
Clearance TypeTraditional
Product CodeOWI
Regulation Number888.3010
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222097
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. OLYMPIC Deformity Band System (K222097) cites 6 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181139 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 |
| K172166 | OLYMPIC Navigated Instruments | Astura Medical | 2018 |
| K173506 | LigaPASS | Medicrea International SA | 2018 |
| K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017 |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014 |
| K131343 | REFORM PEDICLE SCREW SYSTEM | Spinal USA | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023 |
Trace the full predicate network for K222097
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.