510(k) Report

510(k) · Cleared

Cleared

Camber Spine Technologies TLS 5.0 Inerbody Cage

K121254510(k) TraditionalCleared Jan 11, 2013261-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 Technologies · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jan 11, 2013 as substantially equivalent to K073440 (Corelink, LLC, 2008) and 2 other predicates after a 261-day review. Its family tree reaches back 11 generations to 1984. 40 later devices descend from it.

Decided
Jan 11, 2013
Review
261 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
3

Its longest line of descent runs back 11 generations to K841189 (1984). 51 ancestors in all. 40 later devices descend from it, 5 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: 6 descendants cleared2014: 1 descendant cleared2018: 2 descendants cleared2013: 1 descendant cleared2019: 3 descendants cleared2022: 4 descendants cleared2021: 3 descendants 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. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 6 other ancestors4 generations back: 6 other ancestors5 generations back: 9 other ancestors6 generations back: 9 other ancestors7 generations back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 15 descendants4 generations forward: 8 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K113138 · 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 · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  4. 2 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  5. 1 generation backK113138 Aleutian SystemK2m, Inc. · 2012
  6. This deviceK121254 Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013
  7. Descendant · cites it directly · 28 of its ownK134038 Camber Spine Diagon Oblique CageCamber Spine · 2014
  8. Descendant · cites it directly · 27 of its ownK172064 Ti-Diagon Oblique TLIFCamber Spine Technologies · 2017
  9. Descendant · 2 generations on · 15 of its ownK212904 SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 2021
  10. Descendant · 2 generations on · 11 of its ownK213420 WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation · 2022
  11. Descendant · 3 generations on · 9 of its ownK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
Show all 11 generations
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 4 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. 3 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. 2 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. 1 generation backK113138 Aleutian SystemK2m, Inc. · 2012
  12. This deviceK121254 Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12017: 62018: 22019: 32021: 32022: 42023: 32024: 82025: 42026: 5
2013high 8 (2024) · low 0 (2015)2026

Most influential descendants

Showing 5 of 40 · See all
  • K134038Camber Spine Diagon Oblique CageCamber Spine · 2014 · cites it directly28descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−10K990148Stackable Cage SystemDepuy Motech Acromed1999—
−9K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−8K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−7K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−6K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−5K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−4K051454Aleutian Spacer SystemK2m, LLC2005—
−3K063399Aleutian Spacer SystemK2m, Inc.2007—
−2K082698Aleutian Ibf SystemK2m, Inc.2009—
−1K113138Aleutian SystemK2m, Inc.2012—
0 (this device)K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies2013—
+1K134038Camber 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—

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
201310
201410
201760
201820
201930
202130
202240
202330
202480
202540
202650
FIG. 1 — Lineage of K121254, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K073440Foundation Cage
Summary page 2
…21 CFR 888.3080 Classification Panel: Orthopedic Product Code MAX Reason for 510k New Device Predicate Devices Corelink Foundation Cage (K 073440), Stryker AVS PL (K093704) & K2M Aleutian (K113138) Device Description Camber Spine Technologies, TL…
Corelink, LLC2008—
*K093704Avs PL Peek Spacers
Summary page 2
…ification Panel: Orthopedic Product Code MAX Reason for 510k New Device Predicate Devices Corelink Foundation Cage (K 073440), Stryker AVS PL (K093704) & K2M Aleutian (K113138) Device Description Camber Spine Technologies, TLS 5.0 Interbody Cage is a…
Stryker Corp.2009—
*K113138Aleutian System
Summary page 2
…MAX Reason for 510k New Device Predicate Devices Corelink Foundation Cage (K 073440), Stryker AVS PL (K093704) & K2M Aleutian (K113138) Device Description Camber Spine Technologies, TLS 5.0 Interbody Cage is a device for interbody fusi…
K2m, Inc.2012—

Also cleared against K073440: 4 other devices →

What descends from it? (40)

See all 40

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K134038Camber Spine Diagon Oblique CageCamber Spine201428
K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727
K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178
K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180
K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130

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 29 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
  • 7 of the 51 ancestors have a recall of any class.
  • Of its descendants, K134038 (Camber Spine, 2014) has gone furthest, with 28 descendants of its own.
  • 4 other devices also cite its predicate K073440.

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. 2013, 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 TLS 5.0 Interbody Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DOD) of the lumbar spine at one or two contiguous levels from LZ-S1. ODD 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 (126 words)

The Camber Spine Technologies TLS 5.0 Interbody Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DOD) of the lumbar spine at one or two contiguous levels from LZ-S1. ODD 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 TLS 5.0 Interbody Cage isto be used with autologous bone graft and implanted via an open transforamninal or posterior approach.

Camber Spine Technologies TLS 5.0 Interbody 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 K073440

4 other devices cite the same predicate.

  • K162496Foundation 3D InterbodyCorelink, LLC · 2017
  • K150847Foundation Interbody DevicesCorelink, LLC · 2015
  • K133529Camber Spine Coveris Cervical CageCamber Spine · 2014
  • K130506Imse P-TlifInstitute of Musculoskeletal Science & Education · 2013

More from Camber Spine Technologies

17 FDA decisions under this applicant name. See the company

  • K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies · 2024
  • K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies · 2024
  • K230942SPIRA® Posterior Lumbar SpacersCamber Spine Technologies · 2023
  • K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies · 2023
  • K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies · 2023

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/K121254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121254: Camber Spine Technologies TLS 5.0 Inerbody Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121254

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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