510(k) · Cleared
ClearedZipE Knotless Tissue Repair and Attachment Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ziptek, LLC · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Mar 13, 2017 as substantially equivalent to K974847 (Arthrex, Inc., 1998) and 2 other predicates after a 195-day review. Its family tree reaches back 5 generations to 1996. 5 later devices descend from it.
- Decided
- Mar 13, 2017
- Review
- 195 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K961555 (1996). 17 ancestors in all, the oldest K813581 (1982). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 1 generation backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- This deviceK162429 ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC · 2017
- Descendant · cites it directly · 2 of its ownK200028 Coronet Soft Tissue Fixation SystemConextions Medical · 2020
- Descendant · 2 generations on · 1 of its ownK220966 SinefixBAAT Medical Products B.V. · 2023
- Descendant · cites it directly · 1 of its ownK191227 Paratrooper Plantar Plate Repair SystemParagon 28, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK254176 SinefixBAAT Medical Products B.V. · 2026
- Descendant · 2 generations on · 0 of its ownK211322 Paratrooper Plantar Plate Repair SystemParagon 28, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K200028Coronet Soft Tissue Fixation SystemConextions Medical · 2020 · cites it directly2descendants
- K220966SinefixBAAT Medical Products B.V. · 2023 · 2 generations on1descendant
- K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc. · 2020 · cites it directly1descendant
- K254176SinefixBAAT Medical Products B.V. · 2026 · 3 generations on0descendants
- K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −1 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K162429 | ZipE Knotless Tissue Repair and Attachment Devices | Ziptek, LLC | 2017 | — |
| +1 | K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | 2020 | — |
| +2 | K220966 | Sinefix | BAAT Medical Products B.V. | 2023 | — |
| +1 | K191227 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | 2020 | — |
| +3 | K254176 | Sinefix | BAAT Medical Products B.V. | 2026 | — |
| +2 | K211322 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K974847 | 5.0MM Parachute Corkscrew Suture Anchor Model AR-22255, 3.5MM Parachute Corkscrew Suture…Summary page 4…Device Manufacturer Arthrex Parachute Corkscrew Suture Primary (metallic anchor) K974847 Arthrex, Inc. Anch… | 1998 |
| * | K071704 | Sleeve and Button Soft Tissue DevicesSummary page 4…74847 Arthrex, Inc. Anchor Additional K071704 Sleeve and Button Soft Tissue Devices Biomet Sports Medicine Primary (resorbable anchor) K071177… | 2007 |
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 4…Anchor Additional K071704 Sleeve and Button Soft Tissue Devices Biomet Sports Medicine Primary (resorbable anchor) K071177 Arthrex Biocomposite Suture Anchors Arthrex, Inc. Reference (material) K983843 Arth… | 2007 |
| † | K983843 | Bio-Button 6.5MM, Bio-Button 8MM, Model #'S AR-2236B & AR-2238B | 1999 |
| † | K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus… | 2015 |
What descends from it? (5)
2 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 21 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K200028 (Conextions Medical, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K974847.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus…
Read the full statement (104 words)
The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue.
This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162429: ZipE Knotless Tissue Repair and Attachment Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162429
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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