510(k) · Cleared
ClearedPinn-Acl Crosspin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HTY Pin, Fixation, Smooth
Cleared on Jan 19, 2005 as substantially equivalent to K011172 (Arthrex, Inc., 2001) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jan 19, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933948 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933948 | Acufex Endobutton System | Acufex Microsurgical, Inc. | 1994 | — |
| −1 | K974341 | Mitek BTB Absorbable (Pla) Cross Pin | Mitek Products | 1998 | — |
| 0 (this device) | K043106 | Pinn-Acl Crosspin | Linvatec Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K011172 | Arthrex Bio-TransfixSummary page 2…tiveness Pinn-ACL® Crosspin 51 0(k) # _ _ November 5, 2004 D. Predicate/Legally Marketed Devices Bio - Transfix 510(k) # K011172 Arthrex, Inc. Rigid Fix® 510(k) # K974341 Mitek Bionx SmartSc… | 2001 |
| * | K974341 | Mitek BTB Absorbable (Pla) Cross PinSummary page 2…arketed Devices Bio - Transfix 510(k) # K011172 Arthrex, Inc. Rigid Fix® 510(k) # K974341 Mitek Bionx SmartScrew ® 510 (k)#003077 Bionx BioScrew®… | 1998 |
| † | K003077 | Smartscrew Model 222006...227510 | 2001 |
| † | K973758 | Bioscrew Absorbable Interference Srew | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K011172.
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?
The Pinn-ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043106: Pinn-Acl Crosspin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043106
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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