510(k) · Cleared
ClearedAsfora Bullet Cage System
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 Aug 14, 2009 as substantially equivalent to P970013 (Abbott Medical, 2000) and 1 other predicate after a 219-day review. Its family tree reaches back 1 generation to 1996. 31 later devices descend from it.
- Decided
- Aug 14, 2009
- Review
- 219 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P950019 (1996). 2 ancestors in all. 31 later devices descend from it, 4 citing it directly.
- Root · 1 generation backP950019 Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine · 1996 · Recalled
- This deviceK090048 Asfora Bullet Cage SystemMedical Designs, LLC · 2009
- Descendant · cites it directly · 16 of its ownK100820 Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine · 2010
- Descendant · cites it directly · 14 of its ownK112648 Asfora Bullet CageMedical Designs, LLC · 2012
- Descendant · 2 generations on · 11 of its ownK211873 PSX Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 3 generations on · 8 of its ownK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK151900 VariLift-L Interbody Fusion DeviceWenzel Spine, Inc. · 2015
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine · 2010 · cites it directly16descendants
- K112648Asfora Bullet CageMedical Designs, LLC · 2012 · cites it directly14descendants
- K211873PSX Interbody SystemAlphatec Spine, Inc. · 2021 · 2 generations on11descendants
- K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022 · 3 generations on8descendants
- K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation | Stryker Spine | 1996 | 1 |
| 0 (this device) | K090048 | Asfora Bullet Cage System | Medical Designs, LLC | 2009 | — |
| +1 | K100820 | Wenzel Spine Varilift Interbody Fusion System | Wenzel Spine | 2010 | — |
| +1 | K112648 | Asfora Bullet Cage | Medical Designs, LLC | 2012 | — |
| +2 | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +3 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
| +2 | K151900 | VariLift-L Interbody Fusion Device | Wenzel Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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.
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 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? (2)
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 |
|---|---|---|---|
| * | P970013 | Microny PacemakersSummary page 1…sion Device with Bone Graft, Lumbar 21 CFR 888.3080 (MAX) C. Predicate Devices: INTER FIX Tm Threaded Fusion Device (P970013; Downclassified to Class II) Ray TFC Tm Device (P95001… | 2000 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…INTER FIX Tm Threaded Fusion Device (P970013; Downclassified to Class II) Ray TFC Tm Device (P950019; Downclassified to Class HI) D. Device Description: The Asfora Bullet CageTM is comprised of two hollow, threaded, self-ta… | 1996 |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K100820 (Wenzel Spine, 2010) has gone furthest, with 16 descendants of its own.
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. 2009, 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 Asfora Bullet CageTM (ABC) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two levels from L2 to S 1. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ABC cage devices are used with autogenous bone graft and are implanted via an open posterior approach. Patients should have had at least six (6) months of non-operative treatment prior to implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090048: Asfora Bullet Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090048
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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