510(k) · Cleared
ClearedHD Lumbar Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hd Lifesciences, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 13, 2017 as substantially equivalent to K072791 (Synthes Spine, 2007) and 2 other predicates after a 129-day review. Its family tree reaches back 16 generations to 1984. 1 of the 222 devices in its family, counting itself, has a Class I recall. 122 later devices descend from it.
- Decided
- Jul 13, 2017
- Review
- 129 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 99 ancestors in all. 122 later devices descend from it, 7 citing it directly. 1 of the 222 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 1 generation backK160547 Cascadia Interbody SystemK2m · 2016
- This deviceK170676 HD Lumbar Interbody SystemHd Lifesciences, LLC · 2017
- Descendant · cites it directly · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · cites it directly · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 81 of its ownK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
- Descendant · 4 generations on · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 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 backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 8 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 7 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 6 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 5 generations backK103169 AleuttianK2m, Inc. · 2011
- 4 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 1 generation backK160547 Cascadia Interbody SystemK2m · 2016
- This deviceK170676 HD Lumbar Interbody SystemHd Lifesciences, LLC · 2017
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 122 · See all- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · cites it directly106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · cites it directly104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 2 generations on102descendants
- K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc. · 2020 · 3 generations on81descendants
- K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · 4 generations on79descendants
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 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −8 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −7 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −6 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −5 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −4 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −3 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −2 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| −1 | K160547 | Cascadia Interbody System | K2m | 2016 | — |
| 0 (this device) | K170676 | HD Lumbar Interbody System | Hd Lifesciences, LLC | 2017 | — |
| +1 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +1 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +2 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +3 | K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic… | Titan Spine, Inc. | 2020 | — |
| +4 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 1 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 13 | 0 |
| 2024 | 25 | 0 |
| 2025 | 23 | 0 |
| 2026 | 25 | 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? (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 |
|---|---|---|---|
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 5…etary or Predicate Manufacturer Number Model Name Type K072791 OPAL Spacer Synthes Primary K072253 ALIF Spacer Synthes Additiona… | 2007 |
| * | K072253 | Synfix-LR SpacerSummary page 5…Manufacturer Number Model Name Type K072791 OPAL Spacer Synthes Primary K072253 ALIF Spacer Synthes Additional K160547 Cascadia Interbody System K2M Additio… | 2007 |
| * | K160547 | Cascadia Interbody SystemSummary page 5…Type K072791 OPAL Spacer Synthes Primary K072253 ALIF Spacer Synthes Additional K160547 Cascadia Interbody System K2M Additional PERFORMANCE DATA The Lumbar Interbody System has been tested in th… | 2016 |
What descends from it? (122)
See all 1227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180364 | HD LifeSciences Cervical IBFD System | 2018 | 106 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device… | 2019 | 104 |
| K181702 | Tranquil-L Interbody System | 2018 | 8 |
| K181483 | Tranquil Interbody System | 2018 | 6 |
| K200541 | Hive™ Stand-alone Anterior Lumbar Interbody System | 2020 | 1 |
| K231241 | NanoHive Medical Lumbar Interbody System | 2023 | 0 |
| K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | 2020 | 0 |
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 · 4 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 10 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 99 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180364 (Hd Lifesciences, LLC, 2018) has gone furthest, with 106 descendants of its own.
- 28 other devices also cite its predicate K072791.
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 HD Lumbar Interbody System is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170676: HD Lumbar 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/K170676
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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