510(k) · Cleared
Recalled · 2008Femoral Hook
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrotek, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 7, 2004 as substantially equivalent to K033838 (Biomet Manufacturing, Inc., 2004) after a 27-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 7, 2004
- Review
- 27 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922559 (1992). 7 ancestors in all, the oldest K813581 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
- 3 generations backK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
- 2 generations backK984550 Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999
- 1 generation backK033838 Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004 · Recalled
- This deviceK041261 Femoral HookArthrotek, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK053461 Ezloc Femoral Fixation DeviceArthrotek, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053461Ezloc Femoral Fixation DeviceArthrotek, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922559 | Acufex Endofix Button | Acufex Microsurgical, Inc. | 1992 | — |
| −3 | K980155 | Endobutton Continuous Loop | Smith & Nephew, Inc. | 1998 | — |
| −2 | K984550 | Pre-Threaded Endobutton | Smith & Nephew, Inc. | 1999 | — |
| −1 | K033838 | Titanium Toggle Button (S) | Biomet Manufacturing, Inc. | 2004 | 1 |
| 0 (this device) | K041261 | Femoral Hook | Arthrotek, Inc. | 2004 | — |
| +1 | K053461 | Ezloc Femoral Fixation Device | Arthrotek, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (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 |
|---|---|---|---|
| * | K033838 | Titanium Toggle Button (S)Summary page 1…Name: Fastener, fixation, non-degradable, soft tissue Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Titanium Toggle Button (K033838) - Arthrotek Inc. Device Description: The Femoral Hook device includes a body and an arm. The body incorpora… | 2004 |
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 |
|---|---|---|---|
| K053461 | Ezloc Femoral Fixation Device | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2008 | Not classified | Z-1782-2008 | Employee error | This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates… |
| Apr 17, 2008 | Not classified | Z-1783-2008 | Employee error | This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K053461 (Arthrotek, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033838.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041261: Femoral Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041261
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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