510(k) · Cleared
Recalled · Class II · 2015Sleeve with Ziploop Fixation Devices
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 Jun 23, 2010 as substantially equivalent to K071704 (Biomet Sports Medicine, Inc., 2007) and 2 other predicates after a 68-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2010
- Review
- 68 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904436 (1990). 14 ancestors in all, the oldest K813581 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 3 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 2 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 1 generation backK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
- This deviceK101063 Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine · 2010
- Descendant · cites it directly · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
- Descendant · 2 generations on · 0 of its ownK130351 Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK123651 Cinchlock Knotless Suture AnchorPivot Medical · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −3 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −2 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −1 | K071704 | Sleeve and Button Soft Tissue Devices | Biomet Sports Medicine, Inc. | 2007 | — |
| 0 (this device) | K101063 | Sleeve with Ziploop Fixation Devices | Biomet Sports Medicine | 2010 | — |
| +1 | K110473 | Nanotack Suture Anchor 1.4MM | Pivot Medical | 2011 | — |
| +2 | K130351 | Nanotack Suture Anchor 1.4MM with Flex Inserter | Pivot Medical, Inc. | 2013 | — |
| +2 | K123651 | Cinchlock Knotless Suture Anchor | Pivot Medical | 2013 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K071704 | Sleeve and Button Soft Tissue DevicesSummary page 1…er, fixation, nondegradable, soft tissue * JDR (888.3030): Staple, Fixation, Bone Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K(071704 Sleeve and Sutton Soft Tissue DeVices K(973015 Multitak SS Suture System"' K(053344 BioRap… | 2007 |
| * | K973015 | Multitak SS Suture SystemSummary page 1…0): Staple, Fixation, Bone Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K(071704 Sleeve and Sutton Soft Tissue DeVices K(973015 Multitak SS Suture System"' K(053344 BioRaptor T M Suture Anchors Device Description: The Sleeve with… | 1997 |
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…o Which Substantial Equivalence Is Claimed: K(071704 Sleeve and Sutton Soft Tissue DeVices K(973015 Multitak SS Suture System"' K(053344 BioRaptor T M Suture Anchors Device Description: The Sleeve with ZipLoopT" Fixation Devices are a three component assem… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110473 | Nanotack Suture Anchor 1.4MM | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2015 | Class II | Z-1364-2015 | 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 20 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K110473 (Pivot Medical, 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K071704.
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. 2010, 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 with ZipLoopTm Fixation Devices are intended for 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…
Read the full statement (108 words)
The Sleeve with ZipLoopTm Fixation Devices are intended for 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 reconstrudtion, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101063: Sleeve with Ziploop Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101063
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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