510(k) · Cleared
ClearedThe Osteomed B Power System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Cleared on Nov 7, 1994 after a 501-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 7, 1994
- Review
- 501 days
- Class
- Class I
- Product code
- KIJ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK933101 The Osteomed B Power System and AccessoriesOsteomed Corp. · 1994
- Descendant · cites it directly · 1 of its ownK101563 SmartoJeil Medical Corporation · 2010
- Descendant · cites it directly · 0 of its ownK162542 OsteoMed PINNACLE DriverOsteomed · 2017
- Descendant · cites it directly · 0 of its ownK162544 OsteoMed PINNACLE DriverOsteomed · 2017
- Descendant · 2 generations on · 0 of its ownK163308 SmartoJeil Medical Corporation · 2016
Most influential descendants
Showing 4 of 4 · See all- K101563SmartoJeil Medical Corporation · 2010 · cites it directly1descendant
- K162542OsteoMed PINNACLE DriverOsteomed · 2017 · cites it directly0descendants
- K162544OsteoMed PINNACLE DriverOsteomed · 2017 · cites it directly0descendants
- K163308SmartoJeil Medical Corporation · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933101 | The Osteomed B Power System and Accessories | Osteomed Corp. | 1994 | — |
| +1 | K101563 | Smarto | Jeil Medical Corporation | 2010 | — |
| +1 | K162542 | OsteoMed PINNACLE Driver | Osteomed | 2017 | — |
| +1 | K162544 | OsteoMed PINNACLE Driver | Osteomed | 2017 | — |
| +2 | K163308 | Smarto | Jeil Medical Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KIJ? 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
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 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?
- Of its descendants, K101563 (Jeil Medical Corporation, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KIJ devicesKIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KIJ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KIJ
Too few KIJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KIJ
10in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIJ
4in 2025
MAUDE reports naming product code KIJ, 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 | 0 | — | 0 | 10 |
| 2008 | 0 | — | 10 | 4 |
| 2009 | 0 | — | 0 | 265 |
| 2010 | 1 | — | 0 | 424 |
| 2011 | 0 | — | 0 | 1,080 |
| 2012 | 1 | — | 0 | 615 |
| 2013 | 0 | — | 0 | 288 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K933101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933101: The Osteomed B Power System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933101
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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