510(k) · Cleared
ClearedCONDUIT Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 6, 2021 as substantially equivalent to K201605 (Eit Emerging Implant Technologies GmbH, 2020) after a 56-day review. Its family tree reaches back 23 generations to 1984. 1 of the 219 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- May 6, 2021
- Review
- 56 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K841189 (1984). 213 ancestors in all. 5 later devices descend from it, 3 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 2 generations backK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- 1 generation backK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
- This deviceK210728 CONDUIT InstrumentsMedos International SARL · 2021
- Descendant · cites it directly · 3 of its ownK212823 DePuy CONDUIT LLIF Angled InsertersEnztec Limited · 2021
- Descendant · 2 generations on · 1 of its ownK223671 CONDUIT LLIF Straight InsertersEnztec Limited · 2023
- Descendant · 3 generations on · 0 of its ownK232014 CONDUIT™ ATP InsertersEnztec Limited · 2023
- Descendant · cites it directly · 0 of its ownK223688 CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™…Medos International Sàrl · 2023
- Descendant · cites it directly · 0 of its ownK220449 DePuy CONDUIT LLIF SQUID InserterEnztec Limited · 2022
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 5 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 4 generations backK160955 Tritanium® PL CageStryker · 2016
- 3 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 2 generations backK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- 1 generation backK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
- This deviceK210728 CONDUIT InstrumentsMedos International SARL · 2021
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 5 · See all- K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited · 2021 · cites it directly3descendants
- K223671CONDUIT LLIF Straight InsertersEnztec Limited · 2023 · 2 generations on1descendant
- K232014CONDUIT™ ATP InsertersEnztec Limited · 2023 · 3 generations on0descendants
- K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl · 2023 · cites it directly0descendants
- K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −5 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −4 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −3 | K181014 | Tritanium PL Cage | Stryker Spine | 2018 | — |
| −2 | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | 2019 | — |
| −1 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
| 0 (this device) | K210728 | CONDUIT Instruments | Medos International SARL | 2021 | — |
| +1 | K212823 | DePuy CONDUIT LLIF Angled Inserters | Enztec Limited | 2021 | — |
| +2 | K223671 | CONDUIT LLIF Straight Inserters | Enztec Limited | 2023 | — |
| +3 | K232014 | CONDUIT™ ATP Inserters | Enztec Limited | 2023 | — |
| +1 | K223688 | CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments | Medos International Sàrl | 2023 | — |
| +1 | K220449 | DePuy CONDUIT LLIF SQUID Inserter | Enztec Limited | 2022 | — |
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 | 15 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 31 | 1 |
| 2009 | 20 | 0 |
| 2010 | 9 | 0 |
| 2011 | 15 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Summary page 5…vice with Bone Graft, Lumbar C. Predicate Device Names PrimaryPredicate: EIT Cellular Titanium® Interbody Cages (K201605) D. Device Description The CONDUITTM Instruments are non-sterile, reusable instruments that may be used during placement of var… | 2020 |
What descends from it? (5)
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 25 of the 213 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212823 (Enztec Limited, 2021) has gone furthest, with 3 descendants of its own.
- 17 other devices also cite its predicate K201605.
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. 2021, 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 CONDUIT™ Instruments are intended to be used with the EIT Cellular Titanium® Cages: EIT Cellular Titanium® Cervical Cage The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging…
Read the full statement (657 words)
The CONDUIT™ Instruments are intended to be used with the EIT Cellular Titanium® Cages:
EIT Cellular Titanium® Cervical Cage
The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The EIT Cellular Titanium Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion.
EIT Cellular Titanium® ALIF Cage
The EIT Cellular Titanium® ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
EIT Cellular Titanium® TLIF Cage
The EIT Cellular Titanium® TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
EIT Cellular Titanium® T/PLIF Cage
The EIT Cellular Titanium® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210728: CONDUIT Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210728
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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