510(k) · Cleared
ClearedRenovis S141 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 Aug 8, 2017 as substantially equivalent to K143125 (Orthofix Srl, 2014) and 1 other predicate after a 134-day review. Its family tree reaches back 15 generations to 1984. 1 of the 160 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Aug 8, 2017
- Review
- 134 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K841189 (1984). 154 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 2 citing it directly. 1 of the 160 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK170888 Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2017
- Descendant · cites it directly · 4 of its ownK181655 Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2018
- Descendant · 2 generations on · 1 of its ownK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
- Descendant · 3 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 · 2 generations on · 0 of its ownK182007 Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies · 2018
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK103169 AleuttianK2m, Inc. · 2011
- 3 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 2 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 1 generation backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- This deviceK170888 Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2017
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies · 2018 · cites it directly4descendants
- K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025 · 2 generations on1descendant
- K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc. · 2026 · 3 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −3 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −1 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| 0 (this device) | K170888 | Renovis S141 Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2017 | — |
| +1 | K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2018 | — |
| +2 | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +3 | 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 | — |
| +2 | 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 | 15 | 0 |
| 2002 | 9 | 0 |
| 2003 | 12 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 3 | 0 |
| 2007 | 10 | 0 |
| 2008 | 14 | 1 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K143125 | Orthofix True Lok Hexapod System VI.3Summary page 4…Device Class: Class II Regulations 21 CFR 888.3080 and Product Code: MAX Classification panel: Orthopedic C) Primary Predicate: K143125 Renovis S141 Lumbar Interbody Cage System Additional Predicate: K150481 K2M Cascadia D) Date Prepared: June 23, 2017… | 2014 |
| * | K150481 | Cascadia Interbody SystemSummary page 4…0 and Product Code: MAX Classification panel: Orthopedic C) Primary Predicate: K143125 Renovis S141 Lumbar Interbody Cage System Additional Predicate: K150481 K2M Cascadia D) Date Prepared: June 23, 2017 E) Device Description: The Renovis S141 Lumbar Interbody Cage System is F… | 2015 |
What descends from it? (5)
2 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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 32 of the 154 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181655 (Renovis Surgical Technologies, 2018) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K143125.
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. 2017, 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 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…
Read the full statement (116 words)
The Renovis S141 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). 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170888: Renovis S141 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/K170888
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