510(k) · Cleared
ClearedTwin Peaks Lumbar Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineway · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 10, 2015 as substantially equivalent to K081917 (Depuy Spine, Inc., 2009) and 4 other predicates after a 112-day review. Its family tree reaches back 13 generations to 1984. 1 of the 65 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 10, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K841189 (1984). 63 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK133216 Crescent Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK152355 Twin Peaks Lumbar Interbody Fusion SystemSpineway · 2015
- Descendant · cites it directly · 0 of its ownK163180 Hubble IIOrbbo Surgical, LLC · 2016
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK133216 Crescent Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK152355 Twin Peaks Lumbar Interbody Fusion SystemSpineway · 2015
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K163180Hubble IIOrbbo Surgical, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −2 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −1 | K133216 | Crescent Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| 0 (this device) | K152355 | Twin Peaks Lumbar Interbody Fusion System | Spineway | 2015 | — |
| +1 | K163180 | Hubble II | Orbbo Surgical, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 1 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (5)
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 |
|---|---|---|---|
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 4…Predicate Devices The Spineway Implants are substantially equivalent to legally marketed predicate devices. The primary predicate is the DePuy Cage System described in K081917. Additional predicate devices include the Juliet Cage from SpineArt (K101720), the Tribeca Cage from Scient’X (K080588), the Cres… | 2009 |
| * | K101720 | Juliet OLSummary page 4…ally marketed predicate devices. The primary predicate is the DePuy Cage System described in K081917. Additional predicate devices include the Juliet Cage from SpineArt (K101720), the Tribeca Cage from Scient’X (K080588), the Crescent Spinal System from Medtronic (K133216), and the AVS PL PEEK Spacer from… | 2010 |
| * | K080588 | Scient'x Tribeca VBRSummary page 4…ry predicate is the DePuy Cage System described in K081917. Additional predicate devices include the Juliet Cage from SpineArt (K101720), the Tribeca Cage from Scient’X (K080588), the Crescent Spinal System from Medtronic (K133216), and the AVS PL PEEK Spacer from Stryker (K082014).… | 2008 |
| * | K133216 | Crescent Spinal SystemSummary page 4…81917. Additional predicate devices include the Juliet Cage from SpineArt (K101720), the Tribeca Cage from Scient’X (K080588), the Crescent Spinal System from Medtronic (K133216), and the AVS PL PEEK Spacer from Stryker (K082014).… | 2013 |
| * | K082014 | Stryker Spine Avs PL Peek SpacersSummary page 4…iet Cage from SpineArt (K101720), the Tribeca Cage from Scient’X (K080588), the Crescent Spinal System from Medtronic (K133216), and the AVS PL PEEK Spacer from Stryker (K082014). K152355… | 2008 |
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 |
|---|---|---|---|
| K163180 | Hubble II | 2016 | 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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 63 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K163180 (Orbbo Surgical, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 35 other devices also cite its predicate K081917.
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. 2015, 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 Twin Peaks 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 Twin Peaks 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). Twin Peaks 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 Twin Peaks 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/K152355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152355: Twin Peaks 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/K152355
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