510(k) Report

510(k) · Cleared

Cleared

Velofix™ TLIF Cage

K172419510(k) TraditionalCleared Dec 4, 2017116-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

U&I Corporation · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 4, 2017 as substantially equivalent to K132926 (U&I Corp., 2014) and 7 other predicates after a 116-day review. Its family tree reaches back 20 generations to 1984. 1 of the 231 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Dec 4, 2017
Review
116 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
8

Its longest line of descent runs back 20 generations to K841189 (1984). 228 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 231 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 2 other ancestors2014: 7 other ancestors2013: 7 other ancestors2012: 8 other ancestors2010: 19 other ancestors2015: 3 other ancestors2011: 12 other ancestors2009: 25 other ancestors2008: 32 other ancestors, 1 with a Class I recall12001: 10 other ancestors2007: 11 other ancestors2005: 16 other ancestors2004: 22 other ancestors2002: 8 other ancestors1999: 2 other ancestors1996: 2 other ancestors2006: 7 other ancestors2000: 1 other ancestor2003: 14 other ancestors2018: 1 descendant cleared2019: 1 descendant 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) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007×3: 3 generations cleared close together, K080083 (2008), K073109 (2008), K081849 (2008) K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K141942 · Midline II TI · Centinel Spine, Inc. · 2014K150643 · Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti · Centinel Spine, Inc. · 2015×2: 2 generations cleared close together, K152475 (2016), K153495 (2016) K161173 · Avenue® T TLIF Cage · Ldr Spine USA, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 20 other ancestors3 generations back: 41 other ancestors4 generations back: 38 other ancestors5 generations back: 51 other ancestors, 1 with a Class I recall16 generations back: 34 other ancestors7 generations back: 11 other ancestors8 generations back: 3 other ancestors9 generations back: 3 other ancestors 1 generation forward: 2 descendants K161173 · Avenue® T TLIF Cage · Ldr Spine USA, Inc. · 2016K153495 · Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System · Ldr Spine USA · 2016 · recalledK152475 · FORZA PTC Spacer System · Orthofix, Inc. · 2016K150643 · Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti · Centinel Spine, Inc. · 2015K141942 · Midline II TI · Centinel Spine, Inc. · 2014K111122 · Aesculap Sibd XP Spinal System · Aesculap Implant Systems, Inc. · 2011K100802 · Aesculap Implant Systems Sibd Spinal System · Aesculap Implant Systems, Inc. · 2010K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K081849 · Blackstone Pillar SA Partial Vertebral Body Replacement Device · Blackstone Medical, Inc. · 2008 · recalledK073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · 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. · 1984−20−15−10−50
  1. Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 16 generations between
  3. 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
  4. 2 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
  5. 1 generation backK161173 Avenue® T TLIF CageLdr Spine USA, Inc. · 2016
  6. This deviceK172419 Velofix™ TLIF CageU&I Corporation · 2017
  7. Descendant · cites it directly · 1 of its ownK181829 Velofix TLIF CageU&I Corporation · 2018
  8. Descendant · cites it directly · 0 of its ownK183243 Velofix TLIF CageU&I Corporation · 2019
Show all 20 generations
  1. Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 11 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 10 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 9 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  13. 8 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
  14. 7 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
  15. 6 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
  16. 5 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
  17. 4 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
  18. 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
  19. 2 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
  20. 1 generation backK161173 Avenue® T TLIF CageLdr Spine USA, Inc. · 2016
  21. This deviceK172419 Velofix™ TLIF CageU&I Corporation · 2017

Class I recalls in this family

  • K073202 Ardis Spacer5 generations back · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K181829Velofix TLIF CageU&I Corporation · 2018 · cites it directly1descendant
  • K183243Velofix TLIF CageU&I Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−19K990148Stackable Cage SystemDepuy Motech Acromed1999—
−18K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−17K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−16K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−15K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−14K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−13K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−12K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−11K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−10K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−9K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20081
−8K091301Life Spine Stand-Alone Spacer SystemLife Spine2009—
−7K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010—
−6K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011—
−5K141942Midline II TICentinel Spine, Inc.2014—
−4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015—
−3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016—
−2K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage…Ldr Spine USA20161
−1K161173Avenue® T TLIF CageLdr Spine USA, Inc.2016—
0 (this device)K172419Velofix™ TLIF CageU&I Corporation2017—
+1K181829Velofix TLIF CageU&I Corporation2018—
+1K183243Velofix TLIF CageU&I Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200280
2003140
2004220
2005160
200670
2007110
2008321
2009250
2010190
2011120
201280
201370
201470
201530
201620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
FIG. 1 — Lineage of K172419, 1984–2019Source: 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.

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. #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? (8)

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
*K132926Velofixtm Interbody Fusion System
Summary page 4
….3080 Common Name: Intervertebral Body Fusion Device, IBF Device Product Code: MAX Primary Predicate Device: VelofixTM Interbody Fusion System (K132926, K140864) Secondary Predicate Devices: PATRIOT® SPACER (K122097) Atlas Spine Pivoting System (K1007…
U&I Corp.2014—
*K140864Veloxtm Interbody Fusion System
Summary page 4
…mmon Name: Intervertebral Body Fusion Device, IBF Device Product Code: MAX Primary Predicate Device: VelofixTM Interbody Fusion System (K132926, K140864) Secondary Predicate Devices: PATRIOT® SPACER (K122097) Atlas Spine Pivoting System (K100743)…
U&I Corp.2014—
*K122097Patriot Spacers
Summary page 4
…, IBF Device Product Code: MAX Primary Predicate Device: VelofixTM Interbody Fusion System (K132926, K140864) Secondary Predicate Devices: PATRIOT® SPACER (K122097) Atlas Spine Pivoting System (K100743) AVS® Navigator PEEK Spacer (K151…
Globus Medical, Inc.2012—
*K100743Atlas Spine Pivoting System
Summary page 4
…e: VelofixTM Interbody Fusion System (K132926, K140864) Secondary Predicate Devices: PATRIOT® SPACER (K122097) Atlas Spine Pivoting System (K100743) AVS® Navigator PEEK Spacer (K151726) TALON® TLIF Cage (K122518)…
Atlas Spine, Inc.2010—
*K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…
Summary page 4
…Predicate Devices: PATRIOT® SPACER (K122097) Atlas Spine Pivoting System (K100743) AVS® Navigator PEEK Spacer (K151726) TALON® TLIF Cage (K122518) Avenue® T TLIF Cage (K161173)…
Stryker Corporation20161
*K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…
Summary page 4
…Atlas Spine Pivoting System (K100743) AVS® Navigator PEEK Spacer (K151726) TALON® TLIF Cage (K122518) Avenue® T TLIF Cage (K161173) DIO Medical IVA (TLIF) Cage (K162220) D…
Bm Korea Co., Ltd.2013—
*K161173Avenue® T TLIF Cage
Summary page 4
…AVS® Navigator PEEK Spacer (K151726) TALON® TLIF Cage (K122518) Avenue® T TLIF Cage (K161173) DIO Medical IVA (TLIF) Cage (K162220) Description of Device: The VelofixTM TLIF Cage consists of…
Ldr Spine USA, Inc.2016—
*K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
Summary page 4
…TALON® TLIF Cage (K122518) Avenue® T TLIF Cage (K161173) DIO Medical IVA (TLIF) Cage (K162220) Description of Device: The VelofixTM TLIF Cage consists of implants available in various heights, width, length and angle with…
Dio Medical Co., Ltd.2016—

Also cleared against K132926: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K181829Velofix TLIF CageU&I Corporation20181
K183243Velofix TLIF CageU&I Corporation20190

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 33 years and passes through 17 companies; a new generation was cleared every 9 months on median.
  • 34 of the 228 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K181829 (U&I Corporation, 2018) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K132926.

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. 2017, 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 Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

Indications for use as stated in the FDA summary.

Also cleared against K132926

3 other devices cite the same predicate.

  • K252351UniSpace® TPLIF CageCg Medtech Co., Ltd. · 2025
  • K171749Velofix (tm) Interbody Fusion SystemU&I Corporation · 2017
  • K140864Veloxtm Interbody Fusion SystemU&I Corp. · 2014

More from U&I Corporation

23 FDA decisions under this applicant name. See the company

  • K220147Aspiron S ACP SystemU&I Corporation · 2022
  • K210573Velofix SA Cervical CageU&I Corporation · 2021
  • K183243Velofix TLIF CageU&I Corporation · 2019
  • K190067Velofix Interbody Fusion SystemU&I Corporation · 2019
  • K190053SECULOK™ ACP SystemU&I Corporation · 2019

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/K172419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172419: Velofix™ TLIF Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172419

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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