510(k) · Cleared
ClearedArthrex Self-Punching PushLock Suture Anchor
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 May 13, 2022 as substantially equivalent to K101679 (Arthrex, Inc., 2010) after a 29-day review. Its family tree reaches back 7 generations to 1996. 5 later devices descend from it.
- Decided
- May 13, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K961555 (1996). 9 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 1 generation backK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
- This deviceK221099 Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK251145 Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK253931 Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK252664 GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025
- Descendant · 2 generations on · 0 of its ownK262357 Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK254188 Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026
Most influential descendants
Showing 5 of 5 · See all- K251145Arthrex PushLock Suture AnchorsArthrex, Inc. · 2025 · cites it directly2descendants
- K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026 · cites it directly1descendant
- K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda. · 2025 · 2 generations on1descendant
- K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026 · 2 generations on0descendants
- K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −1 | K101679 | Arthrex Pushlock Anchors | Arthrex, Inc. | 2010 | — |
| 0 (this device) | K221099 | Arthrex Self-Punching PushLock Suture Anchor | Arthrex, Inc. | 2022 | — |
| +1 | K251145 | Arthrex PushLock Suture Anchors | Arthrex, Inc. | 2025 | — |
| +1 | K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026 | — |
| +2 | K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | 2025 | — |
| +2 | K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. | 2026 | — |
| +3 | K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
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 |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K101679 | Arthrex Pushlock AnchorsSummary page 4…issue Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener. Regulatory II Classification Predicate Device K101679: Arthrex PushLock Anchors Reference Device K061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio-… | 2010 |
| † | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | 2006 |
| † | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak… | 2009 |
| † | K173240 | Arthrex PushLock | 2018 |
| † | K193503 | Arthrex SwiveLock Suture Anchor | 2020 |
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 26 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K251145 (Arthrex, Inc., 2025) has gone furthest, with 2 descendants of its own.
- 20 other devices also cite its predicate K101679.
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. 2022, 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 self-punching PushLock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221099: Arthrex Self-Punching PushLock Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221099
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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