510(k) · Cleared
ClearedRT2 Trabeculite Titanium Cervical Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhausler, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 19, 2015 as substantially equivalent to K111272 (Rhausler, Inc., 2011) after a 272-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Nov 19, 2015
- Review
- 272 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010530 (2001). 13 ancestors in all, the oldest P950002 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 4 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 3 generations backK072981 Synthes Zero-PSynthes Spine Co.Lp · 2008 · Recalled
- 2 generations backK092521 ZUMA-CSeaspine, Inc. · 2010
- 1 generation backK111272 Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc. · 2011
- This deviceK150455 RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −4 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −3 | K072981 | Synthes Zero-P | Synthes Spine Co.Lp | 2008 | 2 |
| −2 | K092521 | ZUMA-C | Seaspine, Inc. | 2010 | — |
| −1 | K111272 | Rhausler Plage Anterior Cervical Fusion System | Rhausler, Inc. | 2011 | — |
| 0 (this device) | K150455 | RT2 Trabeculite Titanium Cervical Cage System | Rhausler, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K111272 | Rhausler Plage Anterior Cervical Fusion SystemSummary page 4…vice : " 9 )% 6 # : - "Cervical 0" (K111272) 22# " … | 2011 |
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.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111272.
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?
The Rhausler RT² Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment.
This device is intended to be used with supplemental spinal fixation systems.
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/K150455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150455: RT2 Trabeculite Titanium Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150455
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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