510(k) · Cleared
ClearedAsfora Bullet Cage
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 Mar 13, 2012 as substantially equivalent to K090048 (Medical Designs, LLC, 2009) and 1 other predicate after a 183-day review. Its family tree reaches back 2 generations to 1996. 14 later devices descend from it.
- Decided
- Mar 13, 2012
- Review
- 183 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P950019 (1996). 3 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP950019 Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine · 1996 · Recalled
- 1 generation backK090048 Asfora Bullet Cage SystemMedical Designs, LLC · 2009
- This deviceK112648 Asfora Bullet CageMedical Designs, LLC · 2012
- Descendant · cites it directly · 11 of its ownK211873 PSX Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 2 generations on · 8 of its ownK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
- Descendant · 2 generations on · 7 of its ownK231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 7 of its ownK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K211873PSX Interbody SystemAlphatec Spine, Inc. · 2021 · cites it directly11descendants
- K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022 · 2 generations on8descendants
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023 · 2 generations on7descendants
- K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023 · 3 generations on7descendants
- K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation | Stryker Spine | 1996 | 1 |
| −1 | K090048 | Asfora Bullet Cage System | Medical Designs, LLC | 2009 | — |
| 0 (this device) | K112648 | Asfora Bullet Cage | Medical Designs, LLC | 2012 | — |
| +1 | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +2 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
| +2 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | — |
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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K090048 | Asfora Bullet Cage SystemSummary page 1…cation: Class 11 Intervertebral Body Fusion Device 21 CFR 888.3080 Product Code: MAX Predicate Device(s): The subject device is equivalent to the following devices: o K090048, Asfora Bullet Cage System e P950019/S9 Ray TFC Threaded Fusion Cage (down-classified to Class II) Device Description: The Asf… | 2009 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…Fusion Device 21 CFR 888.3080 Product Code: MAX Predicate Device(s): The subject device is equivalent to the following devices: o K090048, Asfora Bullet Cage System e P950019/S9 Ray TFC Threaded Fusion Cage (down-classified to Class II) Device Description: The Asfora Bullet Cage (ABC) is a threaded ti… | 1996 |
What descends from it? (14)
See all 143 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K211873 (Alphatec Spine, Inc., 2021) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K090048.
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. 2012, 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 Cage 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 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). The ABC…
Read the full statement (118 words)
The Asfora Bullet Cage 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 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). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112648: Asfora Bullet Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112648
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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