Chrysalis Intelligence · Product Codes · OWI

OWI · Bone Fixation Cerclage, Sublaminar

Orthopedic · 9 clearances · 9 unique sponsors

Device class
Class II
Regulation 888.3010
Total clearances
9
2020-03-16 → 2026-05-27
Last 12 months
2
Unique sponsors
9
Definition

What is Bone Fixation Cerclage, Sublaminar

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.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3010
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Alphatec Spine, Inc. 1 1 2026-03-25
OrthoPediatrics Corp. 1 0 2020-03-16
Globus Medical, Inc. 1 0 2023-04-20
Medicrea International SA 1 0 2022-05-24
Medicrea International S.A.S 1 1 2026-05-27
Medtronic, Inc. 1 0 2021-05-27
SeaSpine Orthopedics Corporation 1 0 2020-08-05
Astura Medical 1 0 2023-05-04
Ortho Development Corporation 1 0 2020-03-31
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
22840 CPT — Medium Posterior non-segmental instrumentation (eg, Harrington rod technique, pedicle fixation across one interspace, atlantoaxial transarticular screw fixation, sublaminar wiring at C1)
C1867 HCPCS — Medium Spinal orthosis, cervical
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-27 K261374 Medicrea International S.A.S LigaPASS™ System
2026-03-25 K253615 Alphatec Spine, Inc. Invictus Bands System
2023-05-04 K222097 Astura Medical OLYMPIC Deformity Band System
2023-04-20 K230565 Globus Medical, Inc. HILINE™ Fixation System
2022-05-24 K213659 Medicrea International SA LigaPASS™ 2.0 Ligament Augmentation System
2021-05-27 K211057 Medtronic, Inc. LigaPASS® Spinal System, CD Horizon™ Spinal System
2020-08-05 K201240 SeaSpine Orthopedics Corporation Mariner Cap System
2020-03-31 K200281 Ortho Development Corporation The Gecko Spinal System
2020-03-16 K200097 OrthoPediatrics Corp. Response BandLoc Spinal Fixation