510(k) Report

510(k) · Cleared

Cleared

Arthrex Bioabsorbable PushLock Suture Anchors

K253931510(k) TraditionalCleared May 28, 2026170-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on May 28, 2026 as substantially equivalent to K173240 (Arthrex, Inc., 2018) and 6 other predicates after a 170-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.

Decided
May 28, 2026
Review
170 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
7

Its longest line of descent runs back 10 generations to K961555 (1996). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2022: 1 other ancestor2018: 1 other ancestor2010: 1 other ancestor2009: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor1998: 1 other ancestor2011: 1 other ancestor2026: 1 descendant clearedReference device: K251145 · Arthrex PushLock Suture Anchors · Arthrex, Inc. · 2025K961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K061863 · Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family · Arthrex, Inc. · 2006K071177 · Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew · Arthrex, Inc. · 2007K091844 · Arthrex Bio-Composite Suturetak Anchors · Arthrex, Inc. · 2009K110660 · Arthrex Biocomposite Suturetak · Arthrex, Inc. · 2011K140855 · Arthrex Suturetak Suture Anchors · Arthrex, Inc. · 2014K151092 · Arthrex Short Suture Anchors · Arthrex, Inc. · 2016K201786 · Arthrex Mini Hip PushLock · Arthrex, Inc. · 20201995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant K201786 · Arthrex Mini Hip PushLock · Arthrex, Inc. · 2020K151092 · Arthrex Short Suture Anchors · Arthrex, Inc. · 2016K140855 · Arthrex Suturetak Suture Anchors · Arthrex, Inc. · 2014K110660 · Arthrex Biocomposite Suturetak · Arthrex, Inc. · 2011K091844 · Arthrex Bio-Composite Suturetak Anchors · Arthrex, Inc. · 2009K071177 · Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew · Arthrex, Inc. · 2007K061863 · Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family · Arthrex, Inc. · 2006K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996−10−50
  1. Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 6 generations between
  3. 3 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
  4. 2 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
  5. 1 generation backK201786 Arthrex Mini Hip PushLockArthrex, Inc. · 2020
  6. This deviceK253931 Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  7. Descendant · cites it directly · 0 of its ownK262357 Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
Show all 10 generations
  1. Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 7 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
  5. 6 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
  6. 5 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
  7. 4 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
  8. 3 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
  9. 2 generations backK151092 Arthrex Short Suture AnchorsArthrex, Inc. · 2016
  10. 1 generation backK201786 Arthrex Mini Hip PushLockArthrex, Inc. · 2020
  11. This deviceK253931 Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−9K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−8K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−7K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006—
−6K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…Arthrex, Inc.2007—
−5K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc.2009—
−4K110660Arthrex Biocomposite SuturetakArthrex, Inc.2011—
−3K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.2014—
−2K151092Arthrex Short Suture AnchorsArthrex, Inc.2016—
−1K201786Arthrex Mini Hip PushLockArthrex, Inc.2020—
0 (this device)K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.2026—
+1K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200510
200610
200910
201010
201110
201810
202210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K253931, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K173240Arthrex PushLock
Summary page 6
…MAI Classification Name fastener, fixation, biodegradable, soft tissue Regulatory Class II - 21 CFR 888.3030: Primary Predicate Device K173240 – Arthrex PushLock Additional Predicate Devices K061863 – Arthrex Corkscrew Suture Anchor, Tak, and…
Arthrex, Inc.2018—
*K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family
Summary page 6
…biodegradable, soft tissue Regulatory Class II - 21 CFR 888.3030: Primary Predicate Device K173240 – Arthrex PushLock Additional Predicate Devices K061863 – Arthrex Corkscrew Suture Anchor, Tak, and PushLock Family K063479…
Arthrex, Inc.2006—
*K063479Arthrex Pushlock
Summary page 6
…PushLock Additional Predicate Devices K061863 – Arthrex Corkscrew Suture Anchor, Tak, and PushLock Family K063479 – Arthrex 2.5mm PushLock K082810 – Arthrex Bio-Composite Suture Anchors, Expansion…
Arthrex, Inc.2006—
*K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…
Summary page 6
…rew Suture Anchor, Tak, and PushLock Family K063479 – Arthrex 2.5mm PushLock K082810 – Arthrex Bio-Composite Suture Anchors, Expansion of Indications to include Hip…
Arthrex, Inc.2009—
*K101679Arthrex Pushlock Anchors
Summary page 6
…K082810 – Arthrex Bio-Composite Suture Anchors, Expansion of Indications to include Hip K101679 – Arthrex PushLock K201786 – Arthrex Mini Hip PushLock K221099 – Ar…
Arthrex, Inc.2010—
*K201786Arthrex Mini Hip PushLock
Summary page 6
…Anchors, Expansion of Indications to include Hip K101679 – Arthrex PushLock K201786 – Arthrex Mini Hip PushLock K221099 – Arthrex Self-Punching PushLock Suture Anchor Reference Devic…
Arthrex, Inc.2020—
*K221099Arthrex Self-Punching PushLock Suture Anchor
Summary page 6
…o include Hip K101679 – Arthrex PushLock K201786 – Arthrex Mini Hip PushLock K221099 – Arthrex Self-Punching PushLock Suture Anchor Reference Device K251145 – Arthrex PushLock Suture Anchors Purpose o…
Arthrex, Inc.2022—
†K251145Arthrex PushLock Suture AnchorsArthrex, Inc.2025—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260

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 30 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 18 ancestors have a recall of any class.
  • Of its descendants, K262357 (Arthrex, Inc., 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The Arthrex BioComposite PushLock Suture Anchors (4.5 mm) is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization…

Read the full statement (621 words)

The Arthrex BioComposite PushLock Suture Anchors (4.5 mm) is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repairs, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, 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, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, acetabular labral repair.

The Arthrex Bio-PushLock Suture Anchors (3.5 mm) is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis repair

Hip: Capsular repair, acetabular labral repair

The Arthrex BioComposite PushLock Suture Anchors (2.5 mm) is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The Arthrex BioComposite PushLock Suture Anchors (2.4, 2.9 and 3.5 mm) are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow and hip 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, Digital Tendon Transfers (2.9 x 15.5 mm only)

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patella 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, Capsular Repair (2.9 x 15.5 mm only)

The Arthrex BioComposite Mini Hip PushLock Suture Anchors (2.4 mm) is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.

The Arthrex BioComposite Self-Punching PushLock Suture Anchors (3.5 mm) are intended to be used for suture (soft tissue) fixation to bone in the shoulder:

Shoulder: Rotator Cuff Repairs

Indications for use as stated in the FDA summary.

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

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  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026
  • K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025

https://510kreport.com/device/K253931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K253931: Arthrex Bioabsorbable PushLock Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253931

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026