OWI · Class II · 21 CFR 888.3010

FDA Product Code OWI: Bone Fixation Cerclage, Sublaminar

FDA product code OWI covers sublaminar bone fixation cerclage systems used in spinal surgery.

These cables or wires are passed beneath the laminae of the spine to serve as bone anchors for spinal instrumentation constructs, particularly in cases where pedicle screw fixation is not feasible due to anatomy, bone quality, or prior surgery.

OWI devices are Class II medical devices, regulated under 21 CFR 888.3010 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Cousin Biotech Sas, Globus Medical, Inc. and Medicrea International SA.

37
Total
37
Cleared
112d
Avg days
2011
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 79d recently vs 114d historically

FDA 510(k) Cleared Bone Fixation Cerclage, Sublaminar Devices (Product Code OWI)

37 devices
1–24 of 37
Cleared May 27, 2026
LigaPASS™ System
K261374
Medicrea International S.A.S
Orthopedic · 30d
Cleared Mar 25, 2026
Invictus Bands System
K253615
Alphatec Spine, Inc.
Orthopedic · 127d
Cleared May 04, 2023
OLYMPIC Deformity Band System
K222097
Astura Medical
Orthopedic · 290d
Cleared Apr 20, 2023
HILINE™ Fixation System
K230565
Globus Medical, Inc.
Orthopedic · 50d
Cleared May 24, 2022
LigaPASS™ 2.0 Ligament Augmentation System
K213659
Medicrea International SA
Orthopedic · 186d
Cleared May 27, 2021
LigaPASS® Spinal System, CD Horizon™ Spinal System
K211057
Medtronic, Inc.
Orthopedic · 48d
Cleared Aug 05, 2020
Mariner Cap System
K201240
SeaSpine Orthopedics Corporation
Orthopedic · 89d
Cleared Mar 31, 2020
The Gecko Spinal System
K200281
Ortho Development Corporation
Orthopedic · 56d
Cleared Mar 16, 2020
Response BandLoc Spinal Fixation
K200097
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared Aug 02, 2019
JAZZ PF
K191217
Implanet, S.A.
Orthopedic · 88d
Cleared Apr 03, 2019
Karma® Fixation System
K190289
Spinal Elements, Inc.
Orthopedic · 51d
Cleared Mar 21, 2019
NuVasive® VersaTie® System
K190418
Nu Vasive, Incorporated
Orthopedic · 28d
Cleared Sep 06, 2018
Spinal Elements Cerclage System
K180728
Spinal Elements, Inc.
Orthopedic · 170d
Cleared Aug 29, 2018
ResCUBE™ Ligament Fixation System
K181799
Cousin Biotech Sas
Orthopedic · 55d
Cleared Apr 10, 2018
NAJA™ Ligament Correction System
K172206
Cousin Biotech Sas
Orthopedic · 263d
Cleared Apr 03, 2018
LigaPASS
K173506
Medicrea International SA
Orthopedic · 141d
Cleared Dec 07, 2017
NuVasive® VersaTie™ System
K173117
Nuvasive, Inc.
Orthopedic · 69d
Cleared Oct 26, 2017
SILC® Fixation System
K172417
Globus Medical, Inc.
Orthopedic · 77d
Cleared May 16, 2017
TRANSLACE™ Spinal Tethering System
K163181
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 183d
Cleared Apr 05, 2017
NILE Proximal Fixation Spinal System
K161332
K2m, Inc.
Orthopedic · 328d

About Product Code OWI - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code OWI since 2011, with 37 receiving FDA clearance (average review time: 112 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - OWI Product Code

Recent submissions under OWI have taken an average of 79 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.

OWI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →