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