Chrysalis Intelligence · Product Codes · PEK

PEK · Spinous Process Plate

Orthopedic · 13 clearances · 7 unique sponsors

Device class
Class II
Regulation 888.3050
Total clearances
13
2020-08-04 → 2025-12-01
Last 12 months
1
Unique sponsors
7
Definition

What is Spinous Process Plate

A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3050
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
Spinal Simplicity, LLC 7 1 2025-12-01
Flospine 1 0 2023-10-19
Lespine Innovations, LLC 1 0 2021-12-03
Dio Medical Corp. 1 0 2023-03-09
Aurora Spine, Inc. 1 0 2022-07-08
Paradigm Spine GmbH 1 0 2020-08-04
Wenzel Spine, Inc. 1 0 2023-08-15
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
22842 CPT High Posterior non-segmental instrumentation (spinous process plate) for spinal fusion supplementation
22841 CPT Medium Internal spinal fixation without fusion; alternative instrumentation code for spinous process device
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-01 K253250 Spinal Simplicity, LLC Minuteman® G6 MIS Fusion Plate
2024-01-18 K234051 Spinal Simplicity, LLC Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3
2023-11-29 K233527 Spinal Simplicity, LLC Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
2023-10-19 K232484 Flospine KeyLift™ Expandable Interlaminar Stabilization System
2023-08-15 K231807 Wenzel Spine, Inc. primaLOK™ SP Interspinous Fusion System
2023-03-09 K223790 Dio Medical Corp. Huvex Interspinous Fusion System
2022-08-19 K221023 Spinal Simplicity, LLC Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
2022-07-08 K221399 Aurora Spine, Inc. ZIP™ MIS Interspinous Fusion System
2022-03-11 K211880 Spinal Simplicity, LLC Minuteman G5 MIS Fusion Plate
2021-12-15 K212781 Spinal Simplicity, LLC Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
2021-12-03 K213266 Lespine Innovations, LLC Inspan ScrewLES Fusion System
2020-12-10 K200066 Spinal Simplicity, LLC Posterior Fusion Plate, HA Posterior Fusion Plate
2020-08-04 K201704 Paradigm Spine GmbH CoFix System