510(k) · Cleared
ClearedSleeve and Button Soft Tissue Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Sports Medicine, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 17, 2007 as substantially equivalent to K973015 (Bonutti Research, 1997) and 2 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1990. 142 later devices descend from it.
- Decided
- Sep 17, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904436 (1990). 13 ancestors in all, the oldest K813581 (1982). 142 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 2 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 1 generation backK973015 Multitak SS Suture SystemBonutti Research · 1997
- This deviceK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
- Descendant · cites it directly · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- Descendant · cites it directly · 83 of its ownK110145 Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 35 of its ownK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
Showing 5 of 142 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 142 · See all- K083070Toggleloc SystemBiomet Sports Medicine · 2008 · cites it directly94descendants
- K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011 · cites it directly83descendants
- K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc. · 2012 · 2 generations on52descendants
- K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015 · 2 generations on40descendants
- K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp · 2013 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −2 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −1 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| 0 (this device) | K071704 | Sleeve and Button Soft Tissue Devices | Biomet Sports Medicine, Inc. | 2007 | — |
| +1 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| +1 | K110145 | Biomet Sports Medicine Juggerknot Soft Anchor | Biomet, Inc. | 2011 | 3 |
| +2 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| +2 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| +2 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 10 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 6 | 0 |
| 2023 | 16 | 0 |
| 2024 | 14 | 0 |
| 2025 | 13 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K973015 | Multitak SS Suture SystemSummary page 1…Button) Manufacturer Bonutti Research Smith & Nephew Biomet Sports Medicine* 510(k) Number K973015 K053344 K813581 Device Description: The Sleeve and Button Soft Tissue Devices are compri… | 1997 |
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…Manufacturer Bonutti Research Smith & Nephew Biomet Sports Medicine* 510(k) Number K973015 K053344 K813581 Device Description: The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoopTM , a Butto… | 2006 |
| * | K813581 | Cruciate Ligament ButtonSummary page 1…Bonutti Research Smith & Nephew Biomet Sports Medicine* 510(k) Number K973015 K053344 K813581 Device Description: The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoopTM , a Button or a coreless Sleeve struc… | 1982 |
What descends from it? (142)
See all 1424 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K083070 (Biomet Sports Medicine, 2008) has gone furthest, with 94 descendants of its own.
- 4 other devices also cite its predicate K973015.
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. 2007, 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 Sleeve and Button Soft Tissue Devices utilizing ZipLoop TM Technology are intended for soft tissue to bone fixation for the following indications: Shoulder Bankart lesion repair, SLAP lesion repair, 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…
Read the full statement (158 words)
The Sleeve and Button Soft Tissue Devices utilizing ZipLoop TM Technology are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, 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
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular 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
In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:
Knee
ACL/PCL repair/reconstruction
ACL/PCL patellar bone-tendon-bone grafts
Double-Tunnel ACL reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071704: Sleeve and Button Soft Tissue Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071704
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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