510(k) · Cleared
ClearedRigidfix Soft Tissue Acl Crosspin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · HWC Screw, Fixation, Bone
Cleared on May 9, 2001 after a 68-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- May 9, 2001
- Review
- 68 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK010633 Rigidfix Soft Tissue Acl Crosspin SystemMitek Products · 2001
- 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 · 2 generations on · 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 ownK063719 Arthrex Crosspin, Model AR-1964PArthrex, Inc. · 2007
Most influential descendants
Showing 4 of 4 · 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 · 2 generations on0descendants
- K063719Arthrex Crosspin, Model AR-1964PArthrex, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010633 | Rigidfix Soft Tissue Acl Crosspin System | Mitek Products | 2001 | — |
| +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 | — |
| +2 | K130105 | Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +1 | K063719 | Arthrex Crosspin, Model AR-1964P | Arthrex, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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 |
|---|---|---|---|
| * | — | Mitek 3.3mm ST Femoral RigidFix™ Crosspin System Named without a submission number | |
| * | — | Linvatec BioScrew® Absorbable Interference Screw Named without a submission number |
What descends from it? (4)
2 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, K090669 (Depuy Mitek, A Johnson & Johnson Company, 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).
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/K010633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010633: Rigidfix Soft Tissue Acl Crosspin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010633
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026