510(k) · Cleared
ClearedRenovis Tesera C/Tesera SC 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 · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 7, 2018 as substantially equivalent to K153250 (Renovis Surgical Technologies, 2016) and 1 other predicate after a 133-day review. Its family tree reaches back 17 generations to 1984. 1 of the 217 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 7, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K841189 (1984). 216 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet. 1 of the 217 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 2 generations backK170888 Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2017
- 1 generation backK181655 Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2018
- This deviceK182007 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2018
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 9 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 8 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 7 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 6 generations backK103169 AleuttianK2m, Inc. · 2011
- 5 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 4 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 3 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 2 generations backK170888 Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2017
- 1 generation backK181655 Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2018
- This deviceK182007 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2018
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 |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −9 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −8 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −7 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −6 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −5 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −4 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −3 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| −2 | K170888 | Renovis S141 Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2017 | — |
| −1 | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2018 | — |
| 0 (this device) | K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | Renovis Surgical Technologies | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 16 | 0 |
| 2002 | 10 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 13 | 0 |
| 2006 | 9 | 0 |
| 2007 | 13 | 0 |
| 2008 | 28 | 1 |
| 2009 | 10 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2016 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemSummary page 4…ice with integrated fixation, cervical ODP - intervertebral fusion device, cervical Classification panel: Orthopedic C) Primary predicate: K153250-Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System D) Additional Predicate: K181655-Renov… | 2016 |
| * | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System Cleared while this submission was under review Summary page 4…tion panel: Orthopedic C) Primary predicate: K153250-Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System D) Additional Predicate: K181655-Renovis S180 Lateral Lumbar Interbody Fusion System E) Device Description: Tesera (or T3) describes Renovis’ proprietary Tesera… | 2018 |
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 34 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 39 of the 216 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K153250.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Renovis Tesera SC Stand-alone 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 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 Stand-alone ACF System is a…
Read the full statement (230 words)
The Renovis Tesera SC Stand-alone 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 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 Stand-alone 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 Stand-alone 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.
The Renovis Tesera C 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 C 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 C 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/K182007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182007: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182007
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