510(k) · Cleared
ClearedRenovis S141 Lumbar Interbody Cage 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 Feb 6, 2015 as substantially equivalent to K142095 (Renovis Surgical Technologies, Inc., 2014) and 3 other predicates after a 98-day review. Its family tree reaches back 16 generations to 1984. 237 later devices descend from it.
- Decided
- Feb 6, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K841189 (1984). 97 ancestors in all. 237 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK131122 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
- 2 generations backK140106 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- 1 generation backK142095 Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- This deviceK143126 Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015
- Descendant · cites it directly · 235 of its ownK151374 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System…Nu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 234 of its ownK153105 MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 4 generations on · 163 of its ownK192760 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019
- Descendant · 5 generations on · 157 of its ownK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
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 backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 4 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 3 generations backK131122 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
- 2 generations backK140106 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- 1 generation backK142095 Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
- This deviceK143126 Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies · 2015
Showing 5 of 237 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 237 · See all- K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated · 2015 · cites it directly235descendants
- K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated · 2016 · 2 generations on234descendants
- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on227descendants
- K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019 · 4 generations on163descendants
- K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020 · 5 generations on157descendants
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 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −4 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −3 | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, LLC | 2013 | — |
| −2 | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
| −1 | K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
| 0 (this device) | K143126 | Renovis S141 Lumbar Interbody Cage System | Renovis Surgical Technologies | 2015 | — |
| +1 | K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP… | Nu Vasive, Incorporated | 2015 | — |
| +2 | K153105 | MLX™ - Medial Lateral Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +3 | K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +4 | K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2019 | — |
| +5 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 1 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 15 | 0 |
| 2021 | 20 | 0 |
| 2022 | 25 | 0 |
| 2023 | 35 | 0 |
| 2024 | 49 | 0 |
| 2025 | 42 | 0 |
| 2026 | 39 | 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 MAX? 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? (4)
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 |
|---|---|---|---|
| * | K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemSummary page 4…ice The Renovis S141 Lumbar Interbody Cage System is substantially equivalent to legally marketed predicate devices. The primary predicate is the Renovis S134 ALIF cage (K142095) Additional predicate devices are the Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and the K2M Aleutian Spinal… | 2014 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 4…alent to legally marketed predicate devices. The primary predicate is the Renovis S134 ALIF cage (K142095) Additional predicate devices are the Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and the K2M Aleutian Spinal System (K133614). Intended Use / Indications for Use The Renovis S141 L… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…redicate devices. The primary predicate is the Renovis S134 ALIF cage (K142095) Additional predicate devices are the Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and the K2M Aleutian Spinal System (K133614). Intended Use / Indications for Use The Renovis S141 Lumbar Interbody Cage System… | 1999 |
| * | K133614 | Aleutian Ibf SystemSummary page 4…Renovis S134 ALIF cage (K142095) Additional predicate devices are the Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and the K2M Aleutian Spinal System (K133614). Intended Use / Indications for Use The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion p… | 2014 |
What descends from it? (237)
See all 2372 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 31 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 14 of the 97 ancestors have a recall of any class.
- Of its descendants, K151374 (Nu Vasive, Incorporated, 2015) has gone furthest, with 235 descendants of its own.
- 2 other devices also cite its predicate K142095.
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. 2015, 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 S141 Lumbar Interbody Cage 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…
Read the full statement (116 words)
The Renovis S141 Lumbar Interbody Cage 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). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143126: Renovis S141 Lumbar Interbody Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143126
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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