510(k) · Cleared
ClearedRigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HTY Pin, Fixation, Smooth
Cleared on May 17, 2013 as substantially equivalent to K974341 (Mitek Products, 1998) and 3 other predicates after a 122-day review. Its family tree reaches back 11 generations to 1997.
- Decided
- May 17, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K971358 (1997). 66 ancestors in all, the oldest K930893 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 7 generations between
- 3 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 2 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- 1 generation backK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK130105 Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl…Depuy Mitek, A Johnson & Johnson Company · 2013
Show all 11 generations
- Root · 11 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 10 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 9 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 8 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 7 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 6 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 5 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 4 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 3 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 2 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- 1 generation backK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK130105 Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl…Depuy Mitek, A Johnson & Johnson Company · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −10 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −9 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −8 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −7 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −6 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −5 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −4 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| −3 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| −2 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| −1 | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K130105 | Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K974341 | Mitek BTB Absorbable (Pla) Cross PinSummary page 1…URVE ST ACL PLA Cross Pin System SUBSTANCIAL EQUIVALENCE The proposed RIGIDEIX CURVE ST ACL Cross Pin System is substantially equivalent to the following devices: " K974341 RIGIDFIX Femoral 3.3 mur ST Cross Pin Kit (PLA) " K090669, K091041 RIO IDEIX Biocryl 3.3 mm Femoral ST Cross P… | 1998 |
| * | K090669 | Rigidfix Biocryl Cross Pin KitsSummary page 1…IDEIX CURVE ST ACL Cross Pin System is substantially equivalent to the following devices: " K974341 RIGIDFIX Femoral 3.3 mur ST Cross Pin Kit (PLA) " K090669, K091041 RIO IDEIX Biocryl 3.3 mm Femoral ST Cross Pin Kit * K103712 Gryphon PEEK Anchor DEVICE CLASSIFICATIO… | 2009 |
| * | K091041 | Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Summary page 1…VE ST ACL Cross Pin System is substantially equivalent to the following devices: " K974341 RIGIDFIX Femoral 3.3 mur ST Cross Pin Kit (PLA) " K090669, K091041 RIO IDEIX Biocryl 3.3 mm Femoral ST Cross Pin Kit * K103712 Gryphon PEEK Anchor DEVICE CLASSIFICATION PLA Imp… | 2009 |
| * | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordSummary page 1…wing devices: " K974341 RIGIDFIX Femoral 3.3 mur ST Cross Pin Kit (PLA) " K090669, K091041 RIO IDEIX Biocryl 3.3 mm Femoral ST Cross Pin Kit * K103712 Gryphon PEEK Anchor DEVICE CLASSIFICATION PLA Implants: Single/multiple component metallic bone fixation appliances… | 2011 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 13 of the 66 ancestors have a recall of any class.
- 3 other devices also cite its predicate K974341.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 DePuy Mitek RIGIDFIX® CURVE Cross Pin System is indicated for femoral fixation of autograft or allograft anterior cruciate ligament (ACL) soft tissue grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130105: Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130105
Report an extraction error
Are you the manufacturer?
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