# K211903: Shoreline Threaded TruProfile® Plate

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Aug 30, 2021 after 70 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 236 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202064: Admiral ACP System, SeaSpine Orthopedics Corporation (2020) Summary page 5.
- K190885: Elevation Spine Saber-C System, Elevation Spine (2019) Summary page 5.
- K173521: SeaSpine Cabo ACP (Anterior Cervical Plate) System, SeaSpine Orthopedics Corporation (2018) Summary page 5.

## Most influential descendants
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (2024), 5 descendants of its own
- K241375: IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (2025), 3 descendants of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own
- K251575: IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (2025), 0 descendants of its own
- K251965: Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (2025), 0 descendants of its own

## Indications for use
The Shoreline Threaded TruProfile® Plate is intended for anterior cervical fixation (C2-T1) for the following indications: • Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), • Spondylolisthesis, • Trauma (i.e., fracture or dislocation), • Spinal Stenosis, • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), • Tumor, • Pseudarthrosis, • Failed previous fusion.

Source page: https://510kreport.com/device/K211903
Methodology: https://510kreport.com/methodology