510(k) · Cleared
ClearedEturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and Eturn XX-12 K; Eturn XX-16 K Wher
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icotec · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 21, 2011 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 2 other predicates after a 533-day review. Its family tree reaches back 8 generations to 1984. 8 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 533 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K841189 (1984). 11 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 1 generation backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- This deviceK100305 Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09…Icotec · 2011
- Descendant · cites it directly · 5 of its ownK172480 icotec Interbody Cage SystemIcotec AG · 2018
- Descendant · 2 generations on · 2 of its ownK193378 CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK203683 CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK192897 icotec Cervical CageIcotec AG · 2020
- Descendant · cites it directly · 1 of its ownK133126 K7 Lumbar SpacersK7, LLC · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172480icotec Interbody Cage SystemIcotec AG · 2018 · cites it directly5descendants
- K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020 · 2 generations on2descendants
- K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd. · 2021 · 2 generations on1descendant
- K192897icotec Cervical CageIcotec AG · 2020 · 2 generations on1descendant
- K133126K7 Lumbar SpacersK7, LLC · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −1 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| 0 (this device) | K100305 | Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13… | Icotec | 2011 | — |
| +1 | K172480 | icotec Interbody Cage System | Icotec AG | 2018 | — |
| +2 | K193378 | CarboClear Lumbar Cage System | CarboFix Orthopedics, Ltd. | 2020 | — |
| +2 | K203683 | CarboClear Lumbar Cage System | Carbofix Orthpedics, Ltd. | 2021 | — |
| +2 | K192897 | icotec Cervical Cage | Icotec AG | 2020 | — |
| +1 | K133126 | K7 Lumbar Spacers | K7, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…n device Classification: Class 11, Intervertebral Body Fusion Device, 21 CFR 888.3080 Product Code: MAX Predicate Lumbar INF Cage System (P960025) Device(s): KIMBA Tm Spinal Implant (K052533) IMBATM mini (K080349) Device… | 1999 |
| * | K052533 | Kimba Spinal ImplantSummary page 1…Body Fusion Device, 21 CFR 888.3080 Product Code: MAX Predicate Lumbar INF Cage System (P960025) Device(s): KIMBA Tm Spinal Implant (K052533) IMBATM mini (K080349) Device The icotec ETurn Spinal Implant is a hollow, curved frame… | 2005 |
| * | K080349 | Kimba MiniSummary page 1…e: MAX Predicate Lumbar INF Cage System (P960025) Device(s): KIMBA Tm Spinal Implant (K052533) IMBATM mini (K080349) Device The icotec ETurn Spinal Implant is a hollow, curved frame spinal implant comprised Description:… | 2008 |
What descends from it? (8)
2 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 27 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K172480 (Icotec AG, 2018) has gone furthest, with 5 descendants of its own.
- 98 other devices also cite its predicate P960025.
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. 2011, 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 ETurn spinal implant is indicated for spinal fuision procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ETurn devices are to be used with…
Read the full statement (117 words)
The ETurn spinal implant is indicated for spinal fuision procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ETurn devices are to be used with autogenous bone graft. Patients should have had at least six (6) months of non-operative care prior to treatment with this device.
The ETumn spinal implant is intended for use with supplemental fixation such as posterior fixation by pedicle screws and rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100305: Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and Eturn XX-12 K; Eturn XX-16 K Wher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100305
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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