PMA · Approved
ApprovedMicrony Pacemakers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable
Approved on Dec 21, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 1,448-day review. 32 later devices descend from it.
- Decided
- Dec 21, 2000
- Review
- 1,448 days
- Class
- Class III
- Product code
- LWO
- Recalls
- None
32 later devices descend from it, 1 citing it directly.
- This deviceP970013 Microny PacemakersAbbott Medical · 2000
- Descendant · cites it directly · 31 of its ownK090048 Asfora Bullet Cage SystemMedical Designs, LLC · 2009
- Descendant · 2 generations on · 16 of its ownK100820 Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine · 2010
- Descendant · 2 generations on · 14 of its ownK112648 Asfora Bullet CageMedical Designs, LLC · 2012
- Descendant · 3 generations on · 11 of its ownK211873 PSX Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 4 generations on · 8 of its ownK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K090048Asfora Bullet Cage SystemMedical Designs, LLC · 2009 · cites it directly31descendants
- K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine · 2010 · 2 generations on16descendants
- K112648Asfora Bullet CageMedical Designs, LLC · 2012 · 2 generations on14descendants
- K211873PSX Interbody SystemAlphatec Spine, Inc. · 2021 · 3 generations on11descendants
- K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P970013 | Microny Pacemakers | Abbott Medical | 2000 | — |
| +1 | K090048 | Asfora Bullet Cage System | Medical Designs, LLC | 2009 | — |
| +2 | K100820 | Wenzel Spine Varilift Interbody Fusion System | Wenzel Spine | 2010 | — |
| +2 | K112648 | Asfora Bullet Cage | Medical Designs, LLC | 2012 | — |
| +3 | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +4 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090048 | Asfora Bullet Cage System | 2009 | 31 |
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?
- Of its descendants, K090048 (Medical Designs, LLC, 2009) has gone furthest, with 31 descendants of its own.
How does its category compare?
All LWO devicesLWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWO
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWO
Too few LWO 510(k)s in any year since 2007 to give a median.
Recalls per year · LWO
No recall names LWO since 2007.
Adverse event reports per year · LWO
10in 2025
MAUDE reports naming product code LWO, 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 | 8 | — | 0 | 0 |
| 2008 | 10 | — | 0 | 1 |
| 2009 | 5 | — | 0 | 0 |
| 2010 | 7 | — | 0 | 0 |
| 2011 | 10 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 6 | — | 0 | 3 |
| 2018 | 5 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 3 | — | 0 | 16 |
| 2021 | 4 | — | 0 | 12 |
| 2022 | 3 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 16 |
| 2024 | 1 | — | 0 | 10 |
| 2025 | 5 | — | 0 | 10 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P970013 · printed Nov 4, 2026
Cite this page
510(k) Report. “P970013: Microny Pacemakers.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P970013
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026