# K171046: SeaSpine Cambria System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Jul 7, 2017 after 91 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K841189 (1984). 145 ancestors in all.
62 later devices descend from it; 4 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082309: Cambria, Seaspine, Inc. (2009) Summary page 5.
- K162715: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene, SeaSpine Orthopedics Corporation (2016) Summary page 5.
- K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene, Seaspine, Inc. (2014) Summary page 5.
- K151322: Amendia Interbody Fusion Devices, Amendia, Inc. (2015) Summary page 5.

## Most influential descendants
- K172926: SeaSpine Vu cPOD, Zuma-C, Complete Cervical (2017), 61 descendants of its own
- K183083: Shoreline Cervical Interbody RT System (2019), 60 descendants of its own
- K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (2021), 39 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K201646: Shoreline ACS (Anterior Cervical System) (2020), 20 descendants of its own

## Indications for use
Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3‐C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non‐operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system. Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3‐C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non‐operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Source page: https://510kreport.com/device/K171046
Methodology: https://510kreport.com/methodology