# K120345: Honour Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: Jun 13, 2012 after 131 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: 10 generations back to K003155 (2001). 53 ancestors in all.
212 later devices descend from it; 9 cite it directly.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- K042571: Stryker Spine Avs TL Peek Spacer, Stryker Spine (2005) Summary page 2.
- K050624: Stryker Spine Avs PL Peek Spacer, Stryker Spine (2005) Summary page 2.
- K061836: Avs Asl Peek Spacer System, Stryker Spine (2006) Summary page 2.
- K062132: Avs PL Peek Spacer System, Stryker Spine (2006) Summary page 2.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 2.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 2.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer, Choice Spine, Llp (2009)
- K051246: Construx Mini Peek VBR System, Blackstone Medical, Inc. (2005) Summary page 2.
- K081177: Blackstone Medical, Inc., Pillar Spacer System, Blackstone Medical, Inc. (2008) Summary page 2.

## Most influential descendants
- K171140: Matrixx System (2017), 145 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own

## Indications for use
When used as a cervical intervertebral fusion device, the HONOUR devices are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine (e.g., the Blade® Anterior Cervical Plate System). When used as a lumbar intervertebral fusion device, the HONOUR devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine (e.g., the Inertia® Pedicle Screw System). When used as a vertebral body replacement device, the HONOUR devices are indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation systems cleared for use in the thoracolumbar spine (e.g., the Inertia® Pedicle Screw System).

Source page: https://510kreport.com/device/K120345
Methodology: https://510kreport.com/methodology