510(k) · Cleared
ClearedVelofix TLIF Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corporation · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 10, 2019 as substantially equivalent to K172419 (U&I Corporation, 2017) and 2 other predicates after a 231-day review. Its family tree reaches back 22 generations to 1984. 1 of the 288 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 10, 2019
- Review
- 231 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K841189 (1984). 287 ancestors in all. No later device cites it as a predicate yet. 1 of the 288 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK161173 Avenue® T TLIF CageLdr Spine USA, Inc. · 2016
- 2 generations backK172419 Velofix™ TLIF CageU&I Corporation · 2017
- 1 generation backK181829 Velofix TLIF CageU&I Corporation · 2018
- This deviceK183243 Velofix TLIF CageU&I Corporation · 2019
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 12 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 11 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 10 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 9 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 8 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 7 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 6 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 5 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 4 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 3 generations backK161173 Avenue® T TLIF CageLdr Spine USA, Inc. · 2016
- 2 generations backK172419 Velofix™ TLIF CageU&I Corporation · 2017
- 1 generation backK181829 Velofix TLIF CageU&I Corporation · 2018
- This deviceK183243 Velofix TLIF CageU&I Corporation · 2019
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −12 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −11 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −10 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −9 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −8 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −7 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −6 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −5 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −4 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| −3 | K161173 | Avenue® T TLIF Cage | Ldr Spine USA, Inc. | 2016 | — |
| −2 | K172419 | Velofix™ TLIF Cage | U&I Corporation | 2017 | — |
| −1 | K181829 | Velofix TLIF Cage | U&I Corporation | 2018 | — |
| 0 (this device) | K183243 | Velofix TLIF Cage | U&I Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 23 | 0 |
| 2005 | 22 | 0 |
| 2006 | 9 | 0 |
| 2007 | 13 | 0 |
| 2008 | 39 | 1 |
| 2009 | 32 | 0 |
| 2010 | 24 | 0 |
| 2011 | 21 | 0 |
| 2012 | 15 | 0 |
| 2013 | 11 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K172419 | Velofix™ TLIF CageSummary page 4…21 CFR 888.3080 Common Name: Intervertebral Body Fusion Device, IBF Device Product Code: MAX Predicate Device: Primary - VelofixTM TLIF Cage (K172419) Additional - VelofixTM TLIF Cage (K181829) Additional - VelofixTM Interbody Fusion System (K140864) Purpose of submission:… | 2017 |
| * | K181829 | Velofix TLIF CageSummary page 4…ntervertebral Body Fusion Device, IBF Device Product Code: MAX Predicate Device: Primary - VelofixTM TLIF Cage (K172419) Additional - VelofixTM TLIF Cage (K181829) Additional - VelofixTM Interbody Fusion System (K140864) Purpose of submission: This submission is to introduce a titanium a… | 2018 |
| * | K140864 | Veloxtm Interbody Fusion SystemSummary page 4…: MAX Predicate Device: Primary - VelofixTM TLIF Cage (K172419) Additional - VelofixTM TLIF Cage (K181829) Additional - VelofixTM Interbody Fusion System (K140864) Purpose of submission: This submission is to introduce a titanium alloy (per ASTM F136) with expanded graft window of the Vel… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 17 companies; a new generation was cleared every 9 months on median.
- 39 of the 287 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K172419.
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. 2019, 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 Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI 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.
https://510kreport.com/device/K183243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183243: 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/K183243
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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