510(k) · Cleared
Recalled · Class II · 2017Toggleloc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Sports Medicine · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 16, 2008 as substantially equivalent to K043248 (Arthrex, Inc., 2005) and 2 other predicates after a 62-day review. Its family tree reaches back 6 generations to 1979. 94 later devices descend from it. It has been recalled 6 times.
- Decided
- Dec 16, 2008
- Review
- 62 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 6 generations to K792022 (1979). 43 ancestors in all. 94 later devices descend from it, 11 citing it directly.
- Root · 6 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 4 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 3 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 2 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 1 generation backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- This deviceK083070 Toggleloc SystemBiomet Sports Medicine · 2008
- Descendant · cites it directly · 52 of its ownK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- Descendant · 2 generations on · 40 of its ownK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- Descendant · cites it directly · 35 of its ownK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- Descendant · 3 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- Descendant · 4 generations on · 21 of its ownK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc. · 2012 · cites it directly52descendants
- K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015 · 2 generations on40descendants
- K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp · 2013 · cites it directly35descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 3 generations on28descendants
- K191226Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −5 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −4 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −3 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −2 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −1 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | — |
| +1 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| +2 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| +1 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| +3 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +4 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
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 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 13 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 1…n Name: Fastener, fixation, nondegradable, soft tissue (888.3040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: TightRope TM Syndesmosis Device - K043248 (Arthrex) Sleeve and Button Soft Tissue Devices - K071704 (Biomet Sports.Medicine) Titanium Toggle Buttons - K033838 (Biomet Spor… | 2005 |
| * | K071704 | Sleeve and Button Soft Tissue DevicesSummary page 1…8.3040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: TightRope TM Syndesmosis Device - K043248 (Arthrex) Sleeve and Button Soft Tissue Devices - K071704 (Biomet Sports.Medicine) Titanium Toggle Buttons - K033838 (Biomet Sports Medicine, formerly known as Arthrotek, Inc.) Device De… | 2007 |
| * | K033838 | Titanium Toggle Button (S)Summary page 1…alence Is Claimed: TightRope TM Syndesmosis Device - K043248 (Arthrex) Sleeve and Button Soft Tissue Devices - K071704 (Biomet Sports.Medicine) Titanium Toggle Buttons - K033838 (Biomet Sports Medicine, formerly known as Arthrotek, Inc.) Device Description: The ToggleLocTM System contains toggle buttons a… | 2004 |
What descends from it? (94)
See all 9411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex… | 2012 | 52 |
| K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB… | 2013 | 35 |
| K131850 | Tensyn Band | 2013 | 5 |
| K133858 | Tensyn Band | 2014 | 3 |
| K132733 | Orthohelix Syndesmosis Fixation Devices | 2014 | 3 |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | 2017 | 2 |
| K133606 | N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial… | 2014 | 2 |
| K153186 | Adjustable Fixation Device | 2016 | 1 |
| K143092 | Tensyn Plug | 2015 | 1 |
| K181086 | Cortical Fixation Systems | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2017 | Class II | Z-0818-2018 | Packaging process control | Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. |
| Apr 1, 2016 | Class II | Z-1828-2016 | Equipment maintenance | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it… |
| Mar 31, 2010 | Not classified | Z-1952-2010 | Process control | The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long. |
| Mar 31, 2010 | Not classified | Z-1953-2010 | Process control | The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long. |
| Nov 10, 2009 | Not classified | Z-0560-2010 | Labeling mix-ups | Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa. |
| Nov 10, 2009 | Not classified | Z-0559-2010 | Labeling mix-ups | Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 43 ancestors have a recall of any class.
- Of its descendants, K123341 (Arthrex, Inc., 2012) has gone furthest, with 52 descendants of its own.
- 25 other devices also cite its predicate K043248.
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. 2008, 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 ToggleLocTM System Devices are intended for soft tissue to bone fixation for the following indications: Shoulder: Bankart lesion repair, SLAP lesion repairs Acromio-davicular 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…
Read the full statement (146 words)
The ToggleLocTM System Devices are intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repair, SLAP lesion repairs Acromio-davicular 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 Band C ankle fractures (only for ToggieLoc" with Tophat)
Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCLrepair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial 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
HiM Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083070: Toggleloc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083070
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