510(k) · Cleared
ClearedFixated Asfora BULLET CAGE® (FABC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Designs, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 26, 2018 as substantially equivalent to K140106 (Renovis Surgical Technologies, Inc., 2014) and 9 other predicates after a 100-day review. Its family tree reaches back 19 generations to 1984. 1 of the 214 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 26, 2018
- Review
- 100 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 19 generations to K841189 (1984). 213 ancestors in all. No later device cites it as a predicate yet. 1 of the 214 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 1 generation backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- This deviceK181591 Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC · 2018
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 9 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 8 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 7 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 6 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 5 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 4 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 3 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 2 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 1 generation backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- This deviceK181591 Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC · 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 |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −9 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −8 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −7 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −6 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −5 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −4 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −3 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −2 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −1 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| 0 (this device) | K181591 | Fixated Asfora BULLET CAGE® (FABC) | Medical Designs, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 18 | 0 |
| 2006 | 6 | 0 |
| 2007 | 11 | 0 |
| 2008 | 31 | 1 |
| 2009 | 18 | 0 |
| 2010 | 14 | 0 |
| 2011 | 13 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 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? (10)
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 |
|---|---|---|---|
| * | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) SystemSummary page 4…(ASTM F136). Primary Predicate: Primary: S128 Anterior Lumbar Interbody Fusion (ALIF) System (Renovis Surgical Technologies, Inc. – K140106) Additional Predicates: Avenue® L Lateral Lumbar Cage and Avenue® T Posterior Lumbar Cage (LDR Holding… | 2014 |
| * | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Summary page 4…s, Inc. – K140106) Additional Predicates: Avenue® L Lateral Lumbar Cage and Avenue® T Posterior Lumbar Cage (LDR Holding [now Zimmer Biomet] – K153495), Asfora BULLET CAGE® ABC (Medical Designs – K090048, K112648), STALIF (Centinel Spine, Inc.… | 2016 |
| * | K090048 | Asfora Bullet Cage SystemSummary page 4…Avenue® T Posterior Lumbar Cage (LDR Holding [now Zimmer Biomet] – K153495), Asfora BULLET CAGE® ABC (Medical Designs – K090048, K112648), STALIF (Centinel Spine, Inc. – K101301), MC+ (LDR Holding – K043479), SynCage-C (Synthes Spin… | 2009 |
| * | K112648 | Asfora Bullet CageSummary page 4…Posterior Lumbar Cage (LDR Holding [now Zimmer Biomet] – K153495), Asfora BULLET CAGE® ABC (Medical Designs – K090048, K112648), STALIF (Centinel Spine, Inc. – K101301), MC+ (LDR Holding – K043479), SynCage-C (Synthes Spine –… | 2012 |
| * | K101301 | Stalif MidlineSummary page 4…Zimmer Biomet] – K153495), Asfora BULLET CAGE® ABC (Medical Designs – K090048, K112648), STALIF (Centinel Spine, Inc. – K101301), MC+ (LDR Holding – K043479), SynCage-C (Synthes Spine – K024364), Lumbar I/F Cage® (DePuy AcroMed, Inc… | 2010 |
| * | K043479 | MC+ Partial VBRSummary page 4…fora BULLET CAGE® ABC (Medical Designs – K090048, K112648), STALIF (Centinel Spine, Inc. – K101301), MC+ (LDR Holding – K043479), SynCage-C (Synthes Spine – K024364), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025) and AVS®… | 2005 |
| * | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow)Summary page 4…s – K090048, K112648), STALIF (Centinel Spine, Inc. – K101301), MC+ (LDR Holding – K043479), SynCage-C (Synthes Spine – K024364), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025) and AVS® ARIA PEEK Spacers (Stryker Corporation – K14… | 2003 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…. – K101301), MC+ (LDR Holding – K043479), SynCage-C (Synthes Spine – K024364), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025) and AVS® ARIA PEEK Spacers (Stryker Corporation – K143163), TM Ardis® Interbod… | 1999 |
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Summary page 4…es Spine – K024364), Lumbar I/F Cage® (DePuy AcroMed, Inc. – P960025) and AVS® ARIA PEEK Spacers (Stryker Corporation – K143163), TM Ardis® Interbody System (Zimmer Trabecular Metal Technology, Inc. – K113561). Reference Devices:… | 2015 |
| * | K113561 | TM Ardis Interbody System TM Ardis Interbody System InstrumenationSummary page 4…ARIA PEEK Spacers (Stryker Corporation – K143163), TM Ardis® Interbody System (Zimmer Trabecular Metal Technology, Inc. – K113561). Reference Devices: ASFORA ANTERIOR CERVICAL PLATE SYSTEM (Medical Designs – K143688) === Page 5… | 2012 |
| † | K143688 | Asfora Anterior Cervical Plate System | 2015 |
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 16 companies; a new generation was cleared every 9 months on median.
- 29 of the 213 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K140106.
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. 2018, 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 Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at…
Read the full statement (174 words)
The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181591: Fixated Asfora BULLET CAGE® (FABC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181591
Report an extraction error
Are you the manufacturer?
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