510(k) · Cleared
ClearedMitek BTB Absorbable (Pla) Cross Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · HTY Pin, Fixation, Smooth
Cleared on Apr 16, 1998 as substantially equivalent to K933948 (Acufex Microsurgical, Inc., 1994) after a 149-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Apr 16, 1998
- Review
- 149 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933948 (1994). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK933948 Acufex Endobutton SystemAcufex Microsurgical, Inc. · 1994
- This deviceK974341 Mitek BTB Absorbable (Pla) Cross PinMitek Products · 1998
- Descendant · cites it directly · 2 of its ownK090669 Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009
- Descendant · 2 generations on · 1 of its ownK091041 Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and…Depuy Mitek, A Johnson & Johnson Company · 2009
- Descendant · cites it directly · 0 of its ownK130105 Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl…Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · cites it directly · 0 of its ownK043106 Pinn-Acl CrosspinLinvatec Corp. · 2005
- Descendant · cites it directly · 0 of its ownK014305 Resorbable Lactosorb-L Acl CrosspinArthrotek, Inc. · 2002
Most influential descendants
Showing 5 of 5 · See all- K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009 · cites it directly2descendants
- K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company · 2009 · 2 generations on1descendant
- K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly0descendants
- K043106Pinn-Acl CrosspinLinvatec Corp. · 2005 · cites it directly0descendants
- K014305Resorbable Lactosorb-L Acl CrosspinArthrotek, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933948 | Acufex Endobutton System | Acufex Microsurgical, Inc. | 1994 | — |
| 0 (this device) | K974341 | Mitek BTB Absorbable (Pla) Cross Pin | Mitek Products | 1998 | — |
| +1 | K090669 | Rigidfix Biocryl Cross Pin Kits | Depuy Mitek, A Johnson & Johnson Company | 2009 | — |
| +2 | K091041 | Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial… | Depuy Mitek, A Johnson & Johnson Company | 2009 | — |
| +1 | K130105 | Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +1 | K043106 | Pinn-Acl Crosspin | Linvatec Corp. | 2005 | — |
| +1 | K014305 | Resorbable Lactosorb-L Acl Crosspin | Arthrotek, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K933948 | Acufex Endobutton SystemSummary page 1…ation, bone and soft tissue COMMON NAME A device for holding soft tissue in apposition PROPRIETARY NAME Mitek 3.3mm ST Cross Pin PREDICATE DEVICE Acufex EndoButton (K) 933948 DESCRIPTIION OF DEVICE FUNCTION Hold a Semi Tendonosus soft tissue graft in position during healing in the femoral bone tunnel… | 1994 |
What descends from it? (5)
4 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?
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Femoral fixation of autograft or allograft ACL soft tissue grafts
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/K974341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974341: Mitek BTB Absorbable (Pla) Cross Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974341
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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