510(k) Report

510(k) · Cleared

Cleared

Camber Spine Diagon Oblique Cage

K134038510(k) SpecialCleared Mar 20, 201479-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Camber Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Mar 20, 2014 as substantially equivalent to K121254 (Camber Spine Technologies, 2013) after a 79-day review. Its family tree reaches back 12 generations to 1984. 28 later devices descend from it.

Decided
Mar 20, 2014
Review
79 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
1

Its longest line of descent runs back 12 generations to K841189 (1984). 52 ancestors in all. 28 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2010: 1 other ancestor2007: 2 other ancestors2001: 9 other ancestors1999: 2 other ancestors2005: 3 other ancestors1996: 2 other ancestors2004: 8 other ancestors2003: 4 other ancestors2002: 5 other ancestors2000: 1 other ancestor2017: 1 descendant cleared2022: 3 descendants cleared2021: 3 descendants cleared2019: 1 descendant cleared2023: 3 descendants cleared2025: 4 descendants cleared2024: 8 descendants cleared2026: 5 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K051454 · Aleutian Spacer System · K2m, LLC · 2005K063399 · Aleutian Spacer System · K2m, Inc. · 2007K082698 · Aleutian Ibf System · K2m, Inc. · 2009K113138 · Aleutian System · K2m, Inc. · 2012K121254 · Camber Spine Technologies TLS 5.0 Inerbody Cage · Camber Spine Technologies · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 6 other ancestors5 generations back: 6 other ancestors6 generations back: 9 other ancestors7 generations back: 9 other ancestors8 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 12 descendants4 generations forward: 7 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K121254 · Camber Spine Technologies TLS 5.0 Inerbody Cage · Camber Spine Technologies · 2013K113138 · Aleutian System · K2m, Inc. · 2012K082698 · Aleutian Ibf System · K2m, Inc. · 2009K063399 · Aleutian Spacer System · K2m, Inc. · 2007K051454 · Aleutian Spacer System · K2m, LLC · 2005K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  4. 2 generations backK113138 Aleutian SystemK2m, Inc. · 2012
  5. 1 generation backK121254 Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013
  6. This deviceK134038 Camber Spine Diagon Oblique CageCamber Spine · 2014
  7. Descendant · cites it directly · 27 of its ownK172064 Ti-Diagon Oblique TLIFCamber Spine Technologies · 2017
  8. Descendant · 2 generations on · 15 of its ownK212904 SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021
  9. Descendant · 2 generations on · 11 of its ownK213420 WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation · 2022
  10. Descendant · 3 generations on · 9 of its ownK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
  11. Descendant · 4 generations on · 8 of its ownK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
Show all 12 generations
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 5 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. 4 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. 2 generations backK113138 Aleutian SystemK2m, Inc. · 2012
  12. 1 generation backK121254 Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013
  13. This deviceK134038 Camber Spine Diagon Oblique CageCamber Spine · 2014

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2017: 12019: 12021: 32022: 32023: 32024: 82025: 42026: 5
2017high 8 (2024) · low 0 (2018)2026

Most influential descendants

Showing 5 of 28 · See all
  • K172064Ti-Diagon Oblique TLIFCamber Spine Technologies · 2017 · cites it directly27descendants
  • K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on15descendants
  • K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation · 2022 · 2 generations on11descendants
  • K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022 · 3 generations on9descendants
  • K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−11K990148Stackable Cage SystemDepuy Motech Acromed1999—
−10K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−9K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−8K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−7K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−6K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−5K051454Aleutian Spacer SystemK2m, LLC2005—
−4K063399Aleutian Spacer SystemK2m, Inc.2007—
−3K082698Aleutian Ibf SystemK2m, Inc.2009—
−2K113138Aleutian SystemK2m, Inc.2012—
−1K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies2013—
0 (this device)K134038Camber Spine Diagon Oblique CageCamber Spine2014—
+1K172064Ti-Diagon Oblique TLIFCamber Spine Technologies2017—
+2K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation2021—
+2K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation2022—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation2022—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200190
200250
200340
200480
200530
200720
200820
200910
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201910
202130
202230
202330
202480
202540
202650
FIG. 1 — Lineage of K134038, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K121254Camber Spine Technologies TLS 5.0 Inerbody Cage
Summary page 1
…r 21 CFR 888.3080 Classification Panel: Orthopedic Product Code MAX Predicate Devices Camber Spine Technologies TLS 5.0 Interbody Cage (K(121254) Device Description Camber Spine Technologies, Diagon Oblique Cage isa device for interbody fusion o…
Camber Spine Technologies2013—

Also cleared against K121254: 4 other devices →

What descends from it? (28)

See all 28

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727

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 30 years and passes through 10 companies; a new generation was cleared every 1.6 years on median.
  • 7 of the 52 ancestors have a recall of any class.
  • Of its descendants, K172064 (Camber Spine Technologies, 2017) has gone furthest, with 27 descendants of its own.
  • 4 other devices also cite its predicate K121254.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The Camber Spine Technologies Diagon Oblique Cage 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).…

Read the full statement (124 words)

The Camber Spine Technologies Diagon Oblique Cage 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies Diagon Oblique Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.

Camber Spine Technologies Diagon Oblique Cage implants are 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.

Indications for use as stated in the FDA summary.

Also cleared against K121254

4 other devices cite the same predicate.

  • K180071STYLO Interbody Fusion DeviceLegend Spine Technologies · 2018
  • K172064Ti-Diagon Oblique TLIFCamber Spine Technologies · 2017
  • K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
  • K130506Imse P-TlifInstitute of Musculoskeletal Science & Education · 2013

More from Camber Spine

4 FDA decisions under this applicant name. See the company

  • K143490VERTA Corpectomy CageCamber Spine · 2015
  • K133366Orthros Posterior Stabilization SystemCamber Spine · 2014
  • K133529Camber Spine Coveris Cervical CageCamber Spine · 2014

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K134038 · printed Nov 5, 2026

Cite this page

510(k) Report. “K134038: Camber Spine Diagon Oblique Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K134038

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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