510(k) · Cleared
ClearedArthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 21, 2012 as substantially equivalent to K031666 (Arthrex, Inc., 2003) and 2 other predicates after a 51-day review. Its family tree reaches back 7 generations to 1979. 52 later devices descend from it.
- Decided
- Dec 21, 2012
- Review
- 51 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K792022 (1979). 57 ancestors in all. 52 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 2 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 1 generation backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- This deviceK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- Descendant · cites it directly · 40 of its ownK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- Descendant · 2 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- Descendant · 3 generations on · 21 of its ownK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- Descendant · 4 generations on · 13 of its ownK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 5 of its ownK203740 JuggerKnot Soft AnchorRiverpoint Medical · 2021
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015 · cites it directly40descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 2 generations on28descendants
- K191226Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019 · 3 generations on21descendants
- K203495Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · 4 generations on13descendants
- K203740JuggerKnot Soft AnchorRiverpoint Medical · 2021 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −6 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −5 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −2 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −1 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| 0 (this device) | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| +1 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| +2 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +3 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| +4 | K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 | 1 |
| +2 | K203740 | JuggerKnot Soft Anchor | Riverpoint Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSSummary page 1…me fixation fastener CFR MBI - fastener, fixation, nondegradable, soft tissue Predicate Device K03 1666 - Arthrex FiberWire®Button Repair Kit K062 747 - Arthrex RetroButton… | 2003 |
| * | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMSummary page 1…egradable, soft tissue Predicate Device K03 1666 - Arthrex FiberWire®Button Repair Kit K062 747 - Arthrex RetroButton K083070 - Biomet ToggleLoc®DSystem Purpose… | 2006 |
| * | K083070 | Toggleloc SystemSummary page 1…- Arthrex FiberWire®Button Repair Kit K062 747 - Arthrex RetroButton K083070 - Biomet ToggleLoc®DSystem Purpose of Submission IThis Traditional 510(k) premarket notification is… | 2008 |
What descends from it? (52)
See all 526 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150768 | JuggerKnot Soft Anchors | 2015 | 40 |
| K190288 | Arthrex Tenodesis Button | 2019 | 4 |
| K202444 | Knotless TensionTight Button Implant System | 2020 | 1 |
| K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | 2019 | 1 |
| K211049 | Tigon Medical Button System | 2021 | 0 |
| K191426 | FiberTak Button | 2019 | 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 33 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 57 ancestors have a recall of any class.
- Of its descendants, K150768 (Biomet Manufacturing Corp, 2015) has gone furthest, with 40 descendants of its own.
- 4 other devices also cite its predicate K031666.
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. 2012, this device’s year, is highlighted.
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?
The Arthrex Pec Repair Button, Large Pec Button, Biceps Button, and Proximal Biceps Button are used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123341 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123341
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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