510(k) · Cleared
ClearedXenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xenco Medical, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 11, 2015 after a 59-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 11, 2015
- Review
- 59 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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. 2015, 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?
Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of…
Read the full statement (256 words)
Xenco Medical Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of non-operative treatment prior to surgical treatment with the device. The device is intended to be used with supplemental fixation (e.g. anterior plate system).
Xenco Medical Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20˚ lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Xenco Medical device.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K152987 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152987: Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152987
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)
- Page last updated Nov 3, 2026