PMA · Approved
Recalled · Class I · 2018SpF® Implantable Spinal Fusion Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ahp Eos Buyer, Inc. · LOE Stimulator, Invasive Bone Growth
Approved on Apr 30, 1987 through premarket approval, which rests on the device’s own clinical evidence after a 699-day review. It has a Class I recall. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Apr 30, 1987
- Review
- 699 days
- Class
- Class III
- Product code
- LOE
- Recalls
- 3 (3 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P850035 has 51 supplements since 1988: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1988 | 5 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 8 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
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.
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.
- 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2018 | Class I | Z-0287-2019 | Under Investigation by firm | Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. |
| Apr 20, 2017 | Class I | Z-2118-2017 | Other | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the… |
| Apr 20, 2017 | Class I | Z-2119-2017 | Other | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LOE devicesLOE Stimulator, Invasive Bone Growth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOE
Too few LOE 510(k)s in any year since 2007 to give a median.
Recalls per year · LOE
2in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LOE
7in 2025
MAUDE reports naming product code LOE, 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 | 1 | — | 0 | 2 |
| 2008 | 3 | — | 0 | 32 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 4 | — | 0 | 6 |
| 2016 | 4 | — | 0 | 5 |
| 2017 | 4 | — | 0 | 5 |
| 2018 | 16 | — | 2 (2) | 8 |
| 2019 | 4 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 4 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P850035 · printed Nov 6, 2026
Cite this page
510(k) Report. “P850035: SpF® Implantable Spinal Fusion Stimulator.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P850035
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026