510(k) · Cleared
ClearedPhenix Cervical Interbody Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Devices, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 13, 2009 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1996. 14 later devices descend from it.
- Decided
- Jan 13, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P950002 (1996). 5 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK072226 Impix SpacerMedicrea Technologies · 2007
- This deviceK083167 Phenix Cervical Interbody DeviceSpinal Devices, LLC · 2009
- Descendant · cites it directly · 13 of its ownK130948 C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC · 2013
- Descendant · 2 generations on · 8 of its ownK141129 Exactech Cervical Spacer SystemExactech, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK150130 Ascendant TM Cervical Spacer SystemExactech, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK191621 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical…Choice Spine, LLC · 2019
- Descendant · 4 generations on · 3 of its ownK203311 ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC · 2013 · cites it directly13descendants
- K141129Exactech Cervical Spacer SystemExactech, Inc. · 2014 · 2 generations on8descendants
- K150130Ascendant TM Cervical Spacer SystemExactech, Inc. · 2015 · 3 generations on7descendants
- K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC · 2019 · 3 generations on4descendants
- K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K072226 | Impix Spacer | Medicrea Technologies | 2007 | — |
| 0 (this device) | K083167 | Phenix Cervical Interbody Device | Spinal Devices, LLC | 2009 | — |
| +1 | K130948 | C-Fuse Cervical Intervertebral Body Fusion System | Southern Spine, LLC | 2013 | — |
| +2 | K141129 | Exactech Cervical Spacer System | Exactech, Inc. | 2014 | — |
| +3 | K150130 | Ascendant TM Cervical Spacer System | Exactech, Inc. | 2015 | — |
| +3 | K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody… | Choice Spine, LLC | 2019 | — |
| +4 | K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…by FDA are the BAC/Cervical Implant from Zimmer Spine (previously approved as a PMA product under the name of Spine-Tech) (P980048), and the Medicrea IMPIX Interbody Device (K072226). Performance Testing: The pre-clinical testing perf… | 2001 |
| * | K072226 | Impix SpacerSummary page 1…ine (previously approved as a PMA product under the name of Spine-Tech) (P980048), and the Medicrea IMPIX Interbody Device (K072226). Performance Testing: The pre-clinical testing performed indicated that the Phenix CID is substantiall… | 2007 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130948 | C-Fuse Cervical Intervertebral Body Fusion System | 2013 | 13 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K130948 (Southern Spine, LLC, 2013) has gone furthest, with 13 descendants of its own.
- 53 other devices also cite its predicate P980048.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083167: Phenix Cervical Interbody Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083167
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026