510(k) · Cleared
Recalled · Class II · 2025Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 1, 2013 as substantially equivalent to K083070 (Biomet Sports Medicine, 2008) and 2 other predicates after a 209-day review. Its family tree reaches back 8 generations to 1990. 35 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 1, 2013
- Review
- 209 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 8 generations to K904436 (1990). 60 ancestors in all, the oldest K792022 (1979). 35 later devices descend from it, 17 citing it directly.
- Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 6 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 5 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 4 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 3 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 2 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 1 generation backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- This deviceK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013
- Descendant · cites it directly · 4 of its ownK231857 Arthrex TightRope IIArthrex, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- Descendant · cites it directly · 3 of its ownK211770 R3ACT Stabilization SystemParagon 28, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK173278 ToggleLoc SystemBiomet, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K231857Arthrex TightRope IIArthrex, Inc. · 2023 · cites it directly4descendants
- K241235Arthrex TightRope IIArthrex, Inc. · 2024 · 2 generations on3descendants
- K211770R3ACT Stabilization SystemParagon 28, Inc. · 2021 · cites it directly3descendants
- K173278ToggleLoc SystemBiomet, Inc. · 2018 · cites it directly3descendants
- K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −7 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −6 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −5 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −4 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −3 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −2 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −1 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | — |
| +1 | K231857 | Arthrex TightRope II | Arthrex, Inc. | 2023 | — |
| +2 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
| +1 | K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021 | — |
| +1 | K173278 | ToggleLoc System | Biomet, Inc. | 2018 | — |
| +2 | K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K083070 | Toggleloc SystemSummary page 1…fication panel Orthopedic Regulation 888.3040 and 888.3030 Product Code(s) MBI and JDR Legally marketed device(s) K083070 ToggleLocTM System (Biomet) to which equivalence is K102982 EndoButton CL (Smith & Nephew) claimed… | 2008 |
| * | K102982 | Endobutton DirectSummary page 1…888.3040 and 888.3030 Product Code(s) MBI and JDR Legally marketed device(s) K083070 ToggleLocTM System (Biomet) to which equivalence is K102982 EndoButton CL (Smith & Nephew) claimed K1 12990 TightRope RT (Arthrex) Reason for 510(k) A… | 2011 |
| * | K112990 | Acl Tightrope,Acl Tightrope Duuble BundleSummary page 1…egally marketed device(s) K083070 ToggleLocTM System (Biomet) to which equivalence is K102982 EndoButton CL (Smith & Nephew) claimed K1 12990 TightRope RT (Arthrex) Reason for 510(k) Additional metallic ToggleL-oc Tm buttons and ZipLoopTM constructs. submi… | 2011 |
What descends from it? (35)
See all 3517 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231857 | Arthrex TightRope II | 2023 | 4 |
| K211770 | R3ACT Stabilization System | 2021 | 3 |
| K173278 | ToggleLoc System | 2018 | 3 |
| K200028 | Coronet Soft Tissue Fixation System | 2020 | 2 |
| K151004 | PULLUP® Adjustable Juxtacortical Fixation Device | 2015 | 2 |
| K133606 | N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial… | 2014 | 2 |
| K220650 | TriMed Ripcord Device | 2022 | 1 |
| K203121 | Responsive Arthroscopy Thunderbolt System | 2021 | 1 |
| K170440 | KISSloc Suture System | 2017 | 1 |
| K153186 | Adjustable Fixation Device | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2025 | Class II | Z-0212-2026 | Under Investigation by firm | There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop |
| Aug 22, 2017 | Class II | Z-0818-2018 | Packaging process control | Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. |
| Feb 26, 2015 | Class II | Z-1363-2015 | Employee error | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 60 ancestors have a recall of any class.
- Of its descendants, K231857 (Arthrex, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K083070.
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. 2013, 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 ToggleLoc System devices, except the ToggleLoc XTender and ToggleLoc XL devices, are intended for soft tissue to bone fixation for the following indications: Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction…
Read the full statement (210 words)
The ToggleLoc System devices, except the ToggleLoc XTender and ToggleLoc XL devices, are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair
SLAP lesion repairs
Acromio-clavicular repair
Capsular shift/capsulolabral reconstruction
Deltoid repair
Rotator cuff tear repair
Biceps Tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction
Mid- and forefoot repair
Hallux valgus reconstruction
Metatarsal ligament/tendon repair or reconstruction
Achilles tendon repair
Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and Cankle fractures (only for ToggleLoc with ZipTight)
Elbow
Ulnar or radial collateral ligament reconstruction
Lateral epicondylitis repair
Biceps tendon reattachment
Knee
ACL/PCL repair / reconstruction
ACL/PCL patellar bone-tendon-bone grafts
Double-Tunnel ACL reconstruction
Extracapsular repair: MCL, LCL, and posterior oblique ligament
Iliotibial band tenodesis
Patellar tendon repair
VMO advancement
Joint capsule closure
Hand and Wrist
Collateral ligament repair
Scapholunate ligament reconstruction
Tendon transfers in phalanx
Volar plate reconstruction
Hip
Acetabular labral repair
The ToggleLoc XTender device is used for fixation of tendons and ligaments in cases of unanticipated intraoperative complications such as cortical breaching during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction. The ToggleLoc XTender is for use in conjunction with a titanium alloy ToggleLoc device, excluding the ToggleLoc XL devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130033
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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