510(k) · Cleared
ClearedLargo PEEK Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flospine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 20, 2020 as substantially equivalent to K143479 (Tides Medical, 2015) after an 86-day review. Its family tree reaches back 17 generations to 1984. 1 later device descends from it.
- Decided
- Feb 20, 2020
- Review
- 86 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K841189 (1984). 164 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK141896 Coroent SystemNu Vasive, Incorporated · 2014
- 2 generations backK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- 1 generation backK143479 Bluefin Interbody SystemTides Medical · 2015
- This deviceK193255 Largo PEEK Interbody SystemFlospine, LLC · 2020
- Descendant · cites it directly · 0 of its ownK223231 Ti-Largo Cervical Interbody SystemFlospine · 2023
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 backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- 3 generations backK141896 Coroent SystemNu Vasive, Incorporated · 2014
- 2 generations backK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- 1 generation backK143479 Bluefin Interbody SystemTides Medical · 2015
- This deviceK193255 Largo PEEK Interbody SystemFlospine, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K223231Ti-Largo Cervical Interbody SystemFlospine · 2023 · cites it directly0descendants
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 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −3 | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
| −2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| −1 | K143479 | Bluefin Interbody System | Tides Medical | 2015 | — |
| 0 (this device) | K193255 | Largo PEEK Interbody System | Flospine, LLC | 2020 | — |
| +1 | K223231 | Ti-Largo Cervical Interbody System | Flospine | 2023 | — |
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 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 25 | 0 |
| 2009 | 11 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K143479 | Bluefin Interbody SystemSummary page 4…e - Lumbar Classification Code: MAX, ODP Classification Panel: Orthopedic Regulation Number: 21 CFR sections 888.3080 C. PRIMARY PREDICATE DEVICE K143479 Tides Medical Bluefin Interbody Fusion System… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223231 | Ti-Largo Cervical Interbody System | 2023 | 0 |
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 36 years and passes through 13 companies; a new generation was cleared every 1.1 years on median.
- 19 of the 164 ancestors have a recall of any class.
- Of its descendants, K223231 (Flospine, 2023) has gone furthest, with 0 descendants of its own.
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. 2020, 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?
Largo™ Interbody Cages - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Largo™ Interbody Cages - Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior…
Read the full statement (216 words)
Largo™ Interbody Cages - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Largo™ Interbody Cages - Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Largo™ Interbody Cages - Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Largo™ Interbody Cages - Lumbar are indicated for use with autograft bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Largo™ Interbody Cages - Lumbar are intended to be used with supplemental spinal fixation systems, such as pedicle screws. Patients should be skeletally mature and have six (6) months of non-operative therapy prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193255: Largo PEEK Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193255
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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