510(k) · Cleared
ClearedCylox® ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Feb 11, 2025 as substantially equivalent to K201646 (SeaSpine Orthopedics Corporation, 2020) after a 134-day review. Its family tree reaches back 20 generations to 1984. 1 of the 263 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 11, 2025
- Review
- 134 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K841189 (1984). 262 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 263 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- 2 generations backK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
- 1 generation backK201646 Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020
- This deviceK243188 Cylox® STSignus Medizintechnik GmbH · 2025
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 10 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 9 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 8 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 7 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 6 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 5 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 4 generations backK171046 SeaSpine Cambria SystemSeaSpine Orthopedics Corporation · 2017
- 3 generations backK172926 SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation · 2017
- 2 generations backK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
- 1 generation backK201646 Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation · 2020
- This deviceK243188 Cylox® STSignus Medizintechnik GmbH · 2025
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −10 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −9 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −8 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −7 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −6 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −5 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| −4 | K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | 2017 | — |
| −3 | K172926 | SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation | 2017 | — |
| −2 | K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019 | — |
| −1 | K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | 2020 | — |
| 0 (this device) | K243188 | Cylox® ST | Signus Medizintechnik GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 23 | 0 |
| 2005 | 15 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 35 | 1 |
| 2009 | 24 | 0 |
| 2010 | 16 | 0 |
| 2011 | 18 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
1 device in this family has a Class I recall. 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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 |
|---|---|---|---|
| * | K201646 | Shoreline ACS (Anterior Cervical System)Summary page 5…II Reviewing Panel: Orthopedic Product Code: OVE, ODP Primary Predicate Device: K201646 – Shoreline® ACS (Anterior Cervical System) Reference Device: K241438 – SIGNUS TETRIS™ ST, TETRIS™ R ST Dev… | 2020 |
| † | K241438 | Signus Tetris™ St; Signus Tetris™ R St | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 13 companies; a new generation was cleared every 1.6 years on median.
- 29 of the 262 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K201646.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The CYLOX® ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with…
Read the full statement (171 words)
The CYLOX® ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.
The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with autograft bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach.
When used as a standalone system, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one level (C3-T1) and must be used with the CYLOX® ST bone screw fixation or connecting plate and must be secured with the corresponding locking screw.
When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).
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/K243188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243188: Cylox® ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243188
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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