510(k) · Cleared
ClearedRenovis S180 Lateral Lumbar Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 11, 2018 as substantially equivalent to K170888 (Renovis Surgical Technologies, 2017) and 2 other predicates after an 81-day review. Its family tree reaches back 16 generations to 1984. 1 of the 183 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Sep 11, 2018
- Review
- 81 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 178 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 3 citing it directly. 1 of the 183 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 1 generation backK170888 Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2017
- This deviceK181655 Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2018
- Descendant · cites it directly · 1 of its ownK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261353 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL…Kyocera Medical Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK212070 KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK182007 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2018
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 8 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 7 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 6 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 5 generations backK103169 AleuttianK2m, Inc. · 2011
- 4 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 1 generation backK170888 Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2017
- This deviceK181655 Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2018
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 4 of 4 · See all- K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025 · cites it directly1descendant
- K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc. · 2026 · 2 generations on0descendants
- K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc. · 2021 · cites it directly0descendants
- K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −8 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −7 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −6 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −5 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −4 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −3 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −2 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| −1 | K170888 | Renovis S141 Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2017 | — |
| 0 (this device) | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2018 | — |
| +1 | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +2 | K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System… | Kyocera Medical Technologies, Inc. | 2026 | — |
| +1 | K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | 2021 | — |
| +1 | 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 | 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 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 16 | 0 |
| 2002 | 9 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 4 | 0 |
| 2007 | 12 | 0 |
| 2008 | 23 | 1 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K170888 | Renovis S141 Lumbar Interbody Fusion SystemSummary page 4…vice Class: Class II Regulations 21 CFR 888.3080 and Product Code: MAX Classification panel: Orthopedic C) Predicates: • Primary: K170888 Renovis S141 Lumbar Interbody Fusion System • K131122 Renovis S128 Anterior Lumbar Interbody Fusion System • K140106 Renovi… | 2017 |
| * | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) SystemSummary page 4…21 CFR 888.3080 and Product Code: MAX Classification panel: Orthopedic C) Predicates: • Primary: K170888 Renovis S141 Lumbar Interbody Fusion System • K131122 Renovis S128 Anterior Lumbar Interbody Fusion System • K140106 Renovis S128 Anterior Lumbar Interbody Fusion System D) Date P… | 2013 |
| * | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) SystemSummary page 4…anel: Orthopedic C) Predicates: • Primary: K170888 Renovis S141 Lumbar Interbody Fusion System • K131122 Renovis S128 Anterior Lumbar Interbody Fusion System • K140106 Renovis S128 Anterior Lumbar Interbody Fusion System D) Date Prepared: September 10, 2018 E) Device Description: The Reno… | 2014 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 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 1.4 years on median.
- 37 of the 178 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242771 (Kyocera Medical Technologies, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K170888.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Renovis S180 Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis…
Read the full statement (123 words)
The Renovis S180 Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in
skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from
L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history
and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved
level(s). Patients should be skeletally mature and have at least six months of non-operative treatment prior to treatment
with the devices.
The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis
S180 System implants are to be used with autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181655: Renovis S180 Lateral Lumbar Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181655
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