510(k) · Cleared
ClearedRenovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Mar 16, 2016 as substantially equivalent to K102547 (Nuvasive, Inc., 2011) and 2 other predicates after a 128-day review. Its family tree reaches back 14 generations to 1984. 32 later devices descend from it.
- Decided
- Mar 16, 2016
- Review
- 128 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K841189 (1984). 93 ancestors in all, the oldest K792352 (1979). 32 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- This deviceK153250 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2016
- Descendant · cites it directly · 21 of its ownK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
- Descendant · 2 generations on · 19 of its ownK200115 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020
- Descendant · 2 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
- Descendant · cites it directly · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 4 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- This deviceK153250 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2016
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018 · cites it directly21descendants
- K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020 · 2 generations on19descendants
- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 2 generations on18descendants
- K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · cites it directly7descendants
- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −4 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −3 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −1 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| 0 (this device) | K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | Renovis Surgical Technologies | 2016 | — |
| +1 | K173077 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2018 | — |
| +2 | K200115 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2020 | — |
| +2 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
| +1 | K181621 | Stable-C Interbody System | Nexus Spine, LLC | 2018 | — |
| +2 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
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 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 15 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 OVE? 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? (3)
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 |
|---|---|---|---|
| * | K102547 | Coroent Interlock SystemSummary page 4…n, cervical ODP - intervertebral fusion device with bone graft, cervical Classification panel: Orthopedic C) Primary Predicate: K102547 Nuvasive CoRoent Small Interlock D) Device Description: The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) S… | 2011 |
| * | K072981 | Synthes Zero-PSummary page 5…red by the FDA for use in the cervical spine to augment stability. F) Substantial Equivalence Discussion Additional predicate devices include the Depuy/Synthes Zero P (K072981) and Centinel Spine Stalif-C (K072415). The Renovis Tesera SC ACF System cage is manufactured from different material than the pr… | 2008 |
| * | K072415 | Stalif (TM) CSummary page 5…spine to augment stability. F) Substantial Equivalence Discussion Additional predicate devices include the Depuy/Synthes Zero P (K072981) and Centinel Spine Stalif-C (K072415). The Renovis Tesera SC ACF System cage is manufactured from different material than the predicate devices, but has a similar int… | 2008 |
| † | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | 2013 |
| † | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) System | 2014 |
| † | K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System | 2014 |
What descends from it? (32)
See all 325 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 93 ancestors have a recall of any class.
- Of its descendants, K173077 (Neurostructures, Inc., 2018) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K102547.
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. 2016, 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 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.…
Read the full statement (148 words)
The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.
The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly.
When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153250: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153250
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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