510(k) · Cleared
ClearedThreaded Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirschner Medical Corp. · MBJ Fastener, Fixation, Biodegradable, Hard Tissue
Cleared on May 12, 1993 after a 483-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 12, 1993
- Review
- 483 days
- Class
- Class III
- Product code
- MBJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK920188 Threaded PinsKirschner Medical Corp. · 1993
- Descendant · cites it directly · 2 of its ownK020222 Wisorb Malleolar ScrewCambridge Scientific, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK040265 Little Grafter ScrewBiocomposites, Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK073312 Osteotrans-OT ScrewTakiron Co., Ltd. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920188 | Threaded Pins | Kirschner Medical Corp. | 1993 | — |
| +1 | K020222 | Wisorb Malleolar Screw | Cambridge Scientific, Inc. | 2002 | — |
| +2 | K040265 | Little Grafter Screw | Biocomposites, Ltd. | 2004 | — |
| +2 | K073312 | Osteotrans-OT Screw | Takiron Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 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 MBJ? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020222 | Wisorb Malleolar Screw | 2002 | 2 |
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, K020222 (Cambridge Scientific, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MBJ devicesMBJ Fastener, Fixation, Biodegradable, Hard Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBJ
FDA has decided no MBJ device since 2007.
Median 510(k) review, days · MBJ
Too few MBJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MBJ
No recall names MBJ since 2007.
Adverse event reports per year · MBJ
1in 2024
MAUDE reports naming product code MBJ, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K920188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920188: Threaded Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920188
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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