Karma® Fixation System
FDA 510(k) K190289 · Spinal Elements, Inc.
510(k) numberK190289
Submission
- Device name
- Karma® Fixation System
- Applicant
- Spinal Elements, Inc.
Carlsbad, CA, US - Received
- February 11, 2019
- Decision date
- April 3, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWI – Bone Fixation Cerclage, Sublaminar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Other 510(k)s with product code OWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261374 | LigaPASS SystemOWI · Special | Medicrea International S.A.S | 05/27/2026SE |
| K253615 | Invictus Bands SystemOWI · Traditional | Alphatec Spine, Inc. | 03/25/2026SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | Astura Medical | 05/04/2023SE |
| K230565 | HILINE Fixation SystemOWI · Traditional | Globus Medical, Inc. | 04/20/2023SE |
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | Medicrea International SA | 05/24/2022SE |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal SystemOWI · Traditional | Medtronic, Inc. | 05/27/2021SE |
| K201240 | Mariner Cap SystemOWI · Traditional | SeaSpine Orthopedics Corporation | 08/05/2020SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | Ortho Development Corporation | 03/31/2020SE |
| K200097 | Response BandLoc Spinal FixationOWI · Traditional | OrthoPediatrics Corp. | 03/16/2020SE |
| K191217 | Jazz PFOWI · Traditional | Implanet, S.A. | 08/02/2019SE |
More from Implanet, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | 05/15/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | 02/25/2026SE |
| K250773 | Luna® Ti Interbody Fusion SystemMAX · Traditional | 02/04/2026SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | 05/21/2025SE |
| K243916 | Primus Spinal Fixation SystemNKB · Traditional | 02/21/2025SE |
| K234150 | Lucent® XPMAX · Traditional | 03/27/2024SE |
| K231593 | Sapphire X3 Anterior Cervical Plate SystemKWQ · Traditional | 08/02/2023SE |
| K231252 | Ventana L Spinal SystemMAX · Traditional | 06/30/2023SE |
| K222833 | Ventana C Spinal SystemODP · Traditional | 05/19/2023SE |
| K222516 | Mercury® II Spinal SystemNKB · Traditional | 12/01/2022SE |
Questions and answers
When was Karma® Fixation System cleared by the FDA?
Karma® Fixation System (K190289) received a 510(k) decision of Substantially Equivalent on April 3, 2019, 51 days after the submission was received.
What is the product code of K190289?
The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.