# K083167: Phenix Cervical Interbody Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Devices, LLC
- Decided: Jan 13, 2009 after 78 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: 2 generations back to P950002 (1996). 5 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 1.

## Most influential descendants
- K130948: C-Fuse Cervical Intervertebral Body Fusion System (2013), 13 descendants of its own
- K141129: Exactech Cervical Spacer System (2014), 8 descendants of its own
- K150130: Ascendant TM Cervical Spacer System (2015), 7 descendants of its own
- K191621: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System (2019), 4 descendants of its own
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), 3 descendants of its own

## Indications for use
The Phenix Cervical Interbody Device (Phenix CID) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix CID implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Source page: https://510kreport.com/device/K083167
Methodology: https://510kreport.com/methodology