510(k) · Cleared
ClearedArthrex Pushlock Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Oct 22, 2010 as substantially equivalent to K091844 (Arthrex, Inc., 2009) and 2 other predicates after a 129-day review. Its family tree reaches back 6 generations to 1996. 41 later devices descend from it.
- Decided
- Oct 22, 2010
- Review
- 129 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K961555 (1996). 8 ancestors in all. 41 later devices descend from it, 21 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 2 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 1 generation backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- This deviceK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK221099 Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
- Descendant · cites it directly · 4 of its ownK171299 Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK192484 Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK251145 Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc. · 2022 · cites it directly5descendants
- K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · cites it directly4descendants
- K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2017 · cites it directly4descendants
- K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2020 · 2 generations on3descendants
- K251145Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −2 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −1 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| 0 (this device) | K101679 | Arthrex Pushlock Anchors | Arthrex, Inc. | 2010 | — |
| +1 | K221099 | Arthrex Self-Punching PushLock Suture Anchor | Arthrex, Inc. | 2022 | — |
| +1 | K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019 | — |
| +1 | K171299 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2017 | — |
| +2 | K192484 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2020 | — |
| +1 | K251145 | Arthrex PushLock Suture Anchors | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K091844 | Arthrex Bio-Composite Suturetak AnchorsSummary page 1…mmon Name | Product Code - | MALI - Fastener, Fixation, Biodegradable, Soft Tissue Classification Name | HWC — Screw, Fixation, Bone Suture Anchor Predicate Devices | K091844. Arthrex Bio-Composite Suture Tak Anchors K082810: Arthrex BioComposite Suture Anchors K061863: Arthrex PushLock, Tak and Corksc… | 2009 |
| * | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Summary page 1…ation, Biodegradable, Soft Tissue Classification Name | HWC — Screw, Fixation, Bone Suture Anchor Predicate Devices | K091844. Arthrex Bio-Composite Suture Tak Anchors K082810: Arthrex BioComposite Suture Anchors K061863: Arthrex PushLock, Tak and Corkscrew Suture Anchors Device Description and | The A… | 2009 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…on Name | HWC — Screw, Fixation, Bone Suture Anchor Predicate Devices | K091844. Arthrex Bio-Composite Suture Tak Anchors K082810: Arthrex BioComposite Suture Anchors K061863: Arthrex PushLock, Tak and Corkscrew Suture Anchors Device Description and | The Arthrex PushLock Anchors family is similar to t… | 2006 |
What descends from it? (41)
See all 4121 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221099 | Arthrex Self-Punching PushLock Suture Anchor | 2022 | 5 |
| K180951 | Responsive Arthroscopy Suture Anchor System | 2019 | 4 |
| K171299 | Fixone Biocomposite Anchor | 2017 | 4 |
| K251145 | Arthrex PushLock Suture Anchors | 2025 | 2 |
| K232683 | Knotilus+ PEEK Knotless Anchor | 2023 | 2 |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | 2019 | 2 |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | 2019 | 2 |
| K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors | 2019 | 2 |
| K173240 | Arthrex PushLock | 2018 | 2 |
| K171114 | HEALIX ADVANCE KNOTLESS Anchor | 2017 | 2 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K221099 (Arthrex, Inc., 2022) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K091844.
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. 2010, 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 Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis in the following procedures: 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…
Read the full statement (119 words)
The Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis in the following procedures:
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, Metatarsal Ligament Repair/Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Bunionectomy
Knee:
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist:
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow:
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Hip:
Acetabular Labral Repair.
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/K101679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101679: Arthrex Pushlock Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101679
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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