510(k) · Cleared
ClearedRigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Aug 7, 2009 as substantially equivalent to K090669 (Depuy Mitek, A Johnson & Johnson Company, 2009) and 2 other predicates after a 116-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Aug 7, 2009
- Review
- 116 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K971358 (1997). 16 ancestors in all, the oldest K933948 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 5 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 3 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 2 generations backK032167 Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
- 1 generation backK090669 Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009
- This deviceK091041 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
Most influential descendants
Showing 1 of 1 · See all- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −5 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −3 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −2 | K032167 | Bio-Intrafix Tibial Screw and Sheath | Mitek Worldwide | 2003 | — |
| −1 | K090669 | Rigidfix Biocryl Cross Pin Kits | Depuy Mitek, A Johnson & Johnson Company | 2009 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K090669 | Rigidfix Biocryl Cross Pin KitsSummary page 1…Substantial Equivalence RigidFix Biocryl Cross Pin Kits are substantially equivalent to: · K090669 RigidFix Biocryl Cross Pin Kits (April 03, 2009). Biolntrafix Tibial Tapered She… | 2009 |
| * | K032167 | Bio-Intrafix Tibial Screw and SheathSummary page 1…Tibial Tapered Sheaths and Screws are substantially (Divisi n'ign-Off) CMuIvalent to: Division of Surgical, Orthopedic, · K032167 Biolntrafix Tibial Tapered Sheaths and Screws (October and Restorative Devices 15, 2003).… | 2003 |
| * | K013572 | Mitek Biocryl Interference ScrewsSummary page 1…/L.(.>C7/ 6 Biocryl Interference Screws are substantially equivalent to: 510(k) Number, · K013572 Biocryl Interference Screws (March 14, 2002). Premarket Notification: Traditional RigidFix Biocryl Cross Pin Kits,… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130105 | Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin System | 2013 | 0 |
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 12 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K130105 (Depuy Mitek, A Johnson & Johnson Company, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090669.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
RigidFix Biocryl Cross Pin Kits The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts. The RigidFix Biocryl Femoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis). The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autograft or allograft ACL…
Read the full statement (131 words)
RigidFix Biocryl Cross Pin Kits
The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts.
The RigidFix Biocryl Femoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis).
Biolntrafix Tibial Tapered Sheaths and Screws
The Biolntrafix Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.
Biocryl Interference Screws
The Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091041: Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091041
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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