510(k) · Cleared
ClearedPorosteon Phusion Metal Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porosteon, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 19, 2014 as substantially equivalent to K103033 (Zimmer Trabecular Metal Technology, 2011) after a 144-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Dec 19, 2014
- Review
- 144 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P980048 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 1 generation backK103033 Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and…Zimmer Trabecular Metal Technology · 2011
- This deviceK142041 Porosteon Phusion Metal Cervical CagePorosteon, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK201769 Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −1 | K103033 | Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx | Zimmer Trabecular Metal Technology | 2011 | — |
| 0 (this device) | K142041 | Porosteon Phusion Metal Cervical Cage | Porosteon, Inc. | 2014 | — |
| +1 | K201769 | Cavetto [MAX] Cervical Cage System | Neurostructures, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K103033 | Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxSummary page 4…device - cervical Classification Code: ODP – Class II Classification Panel: Orthopedic Regulation Number: 21 CFR section 888.3080 C. PREDICATE DEVICES K103033 Trabecular Metal Fusion Device; manufactured by Zimmer Trabecular Metal Technology, I… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201769 | Cavetto [MAX] Cervical Cage System | 2020 | 0 |
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 9.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K201769 (Neurostructures, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K103033.
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. 2014, 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 Phusion Metal Cervical Cage 1s indicated for intervertebral body fusion of the spine in skeletally mature patients.
The Phusion Metal Cervical Cage 1s intended for use at one level in the cervical spine, from C3 to C7, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Phusion Metal Cervical Cage is to be used in patients who have had six weeks of non-operative treatment. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142041: Porosteon Phusion Metal Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142041
Report an extraction error
Are you the manufacturer?
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