510(k) · Cleared
Recalled · Class II · 2016Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless Sof
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 Mar 18, 2013 as substantially equivalent to K080088 (Biomet Manufacturing, Inc., 2008) and 1 other predicate after a 125-day review. Its family tree reaches back 5 generations to 1995. It has been recalled 2 times.
- Decided
- Mar 18, 2013
- Review
- 125 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943806 (1995). 35 ancestors in all, the oldest K813581 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
- 4 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- 3 generations backK033355 Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004
- 2 generations backK061389 Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
- 1 generation backK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
- This deviceK123485 Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors…Biomet Sports Medicine · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943806 | Harpoon Suture Anchors | Biomet, Inc. | 1995 | — |
| −4 | K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | 2001 | — |
| −3 | K033355 | Lactoscrew Screw Anchor | Biomet Orthopedics, Inc. | 2004 | — |
| −2 | K061389 | Allthread Lactosorb Suture Anchor | Arthrotek, Inc. | 2006 | — |
| −1 | K080088 | Biomet Sports Medicine Anchor Devices and Ziploop Constructs | Biomet Manufacturing, Inc. | 2008 | 8 |
| 0 (this device) | K123485 | Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless… | Biomet Sports Medicine | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K080088 | Biomet Sports Medicine Anchor Devices and Ziploop ConstructsSummary page 1….3040) MBI Staple, fixation, bone (21CFR §888.3030) JDR Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K080088 Biomet Sports Medidine Anchor Devices and ZipLoop7"' Constructs K110145 JuggerKnot TM Soft Anchors Device Descrip… | 2008 |
| * | K110145 | Biomet Sports Medicine Juggerknot Soft AnchorSummary page 1…030) JDR Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K080088 Biomet Sports Medidine Anchor Devices and ZipLoop7"' Constructs K110145 JuggerKnot TM Soft Anchors Device Description: The JuggerKnotleSST"' Soft Anchors consist of a coreless sleeve structure and… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
| Oct 10, 2013 | Class II | Z-0364-2014 | Device Design | Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 35 ancestors have a recall of any class.
- 3 other devices also cite its predicate K080088.
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 JuggerKnotlessTM Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows: Shoulder Acmomio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle Achilles Tendon…
Read the full statement (130 words)
The JuggerKnotlessTM Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder
Acmomio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle
Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow
Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee
Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist
Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction
Hip
Labral
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123485 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123485: Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless Sof.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123485
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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