510(k) · Cleared
ClearedFBC 921 (Alif)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fbc Device Aps · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jul 12, 2018 as substantially equivalent to K102738 (Lanx, LLC, 2011) and 6 other predicates after a 118-day review. Its family tree reaches back 17 generations to 1984. 1 of the 167 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 12, 2018
- Review
- 118 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K841189 (1984). 166 ancestors in all. No later device cites it as a predicate yet. 1 of the 167 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- This deviceK180695 FBC 921 (Alif)Fbc Device Aps · 2018
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 4 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- This deviceK180695 FBC 921 (Alif)Fbc Device Aps · 2018
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −4 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −3 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −2 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −1 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K180695 | FBC 921 (Alif) | Fbc Device Aps | 2018 | — |
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 | 14 | 0 |
| 2004 | 17 | 0 |
| 2005 | 14 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 27 | 1 |
| 2009 | 12 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K102738 | Lanx Fusion SystemSummary page 4…OVD CFR section 888.3080 Device panel ORTHOPEDIC Primary predicate: Lanx Fusion System manufactured by Lanx, LLC (K102738) Additional predicates: Lanx Fusion System manufactured by Lanx, LLC (K123767); Infix… | 2011 |
| * | K123767 | Lanx Fusion System- SASummary page 4…Primary predicate: Lanx Fusion System manufactured by Lanx, LLC (K102738) Additional predicates: Lanx Fusion System manufactured by Lanx, LLC (K123767); Infix Anterior Lumbar System manufactured by Zimmer Spine, INC (K132790); 4WEB Spinal Legally markete… | 2013 |
| * | K132790 | Infix Anterior Lumbar SystemSummary page 4…Additional predicates: Lanx Fusion System manufactured by Lanx, LLC (K123767); Infix Anterior Lumbar System manufactured by Zimmer Spine, INC (K132790); 4WEB Spinal Legally marketed Implant Products manufactured by 4WEB, INC (K112316, K142112); Alif Interfixated predicat… | 2013 |
| * | K112316 | 4-Web Alif Spinal Truss System (STS)Summary page 4…Anterior Lumbar System manufactured by Zimmer Spine, INC (K132790); 4WEB Spinal Legally marketed Implant Products manufactured by 4WEB, INC (K112316, K142112); Alif Interfixated predicate devices System manufactured by Nuvasive, INC (K151214); Synfix Evolution Secured S… | 2011 |
| * | K142112 | 4WEB Spinal Implant ProductsSummary page 4…Anterior Lumbar System manufactured by Zimmer Spine, INC (K132790); 4WEB Spinal Legally marketed Implant Products manufactured by 4WEB, INC (K112316, K142112); Alif Interfixated predicate devices System manufactured by Nuvasive, INC (K151214); Synfix Evolution Secured Spacer… | 2014 |
| * | K151214 | ALIF Interfixated SystemSummary page 4…egally marketed Implant Products manufactured by 4WEB, INC (K112316, K142112); Alif Interfixated predicate devices System manufactured by Nuvasive, INC (K151214); Synfix Evolution Secured Spacer System manufactured by Synthes (USA) (K150673)… | 2015 |
| * | K150673 | SYNFIX Evolution Secured Spacer SystemSummary page 4…predicate devices System manufactured by Nuvasive, INC (K151214); Synfix Evolution Secured Spacer System manufactured by Synthes (USA) (K150673) Reference Device: Pyramid Anterior Plate Fixation System manufactured by Medtronic… | 2015 |
| † | K013665 | Pyramid Anterior Plate Fixation System | 2002 |
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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 166 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K102738.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal…
Read the full statement (115 words)
The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180695 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180695: FBC 921 (Alif).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180695
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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