510(k) Report

510(k) · Cleared

Cleared

Pushlock

K051219510(k) SpecialCleared Jun 29, 200548-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 Jun 29, 2005 as substantially equivalent to K971723 (Arthrex, Inc., 1997) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1997. 151 later devices descend from it.

Decided
Jun 29, 2005
Review
48 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K971723 (1997). 2 ancestors in all. 151 later devices descend from it, 14 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2014: 9 descendants cleared2010: 8 descendants cleared2011: 11 descendants cleared2006: 3 descendants cleared2017: 6 descendants cleared2009: 10 descendants cleared2012: 8 descendants cleared2019: 7 descendants cleared2018: 7 descendants cleared2021: 5 descendants cleared2008: 3 descendants cleared2007: 1 descendant cleared2020: 7 descendants cleared2013: 10 descendants cleared2023: 13 descendants cleared2015: 12 descendants cleared2016: 3 descendants cleared2024: 6 descendants cleared2022: 5 descendants cleared2025: 10 descendants cleared2026: 7 descendants clearedK971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 14 descendants2 generations forward: 29 descendants3 generations forward: 28 descendants4 generations forward: 32 descendants5 generations forward: 28 descendants6 generations forward: 14 descendants7 generations forward: 6 descendants K971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 19970+5
  1. Root · 1 generation backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
  2. This deviceK051219 PushlockArthrex, Inc. · 2005
  3. Descendant · cites it directly · 64 of its ownK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
  4. Descendant · cites it directly · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
  5. Descendant · 2 generations on · 41 of its ownK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
  6. Descendant · cites it directly · 33 of its ownK060914 Trident AnchorJohnson & Johnson Company · 2006
  7. Descendant · 2 generations on · 32 of its ownK063478 Versalok Anchor with Free Strands of Orthocord Suture (210808)…Depuy Mitek, A Johnson & Johnson Company · 2006

Showing 5 of 151 descendants. See all descendants

Descendants cleared per year

2006: 32007: 12008: 32009: 102010: 82011: 112012: 82013: 102014: 92015: 122016: 32017: 62018: 72019: 72020: 72021: 52022: 52023: 132024: 62025: 102026: 7
2006high 13 (2023) · low 1 (2007)2026

Most influential descendants

Showing 5 of 151 · See all
  • K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008 · cites it directly64descendants
  • K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · cites it directly50descendants
  • K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009 · 2 generations on41descendants
  • K060914Trident AnchorJohnson & Johnson Company · 2006 · cites it directly33descendants
  • K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture…Depuy Mitek, A Johnson & Johnson Company · 2006 · 2 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971723Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc.1997—
0 (this device)K051219PushlockArthrex, Inc.2005—
+1K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.2008—
+1K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.2006—
+2K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.2009—
+1K060914Trident AnchorJohnson & Johnson Company2006—
+2K063478Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond…Depuy Mitek, A Johnson & Johnson Company2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200710
200830
2009100
201080
2011110
201280
2013100
201490
2015120
201630
201760
201870
201970
202070
202150
202250
2023130
202460
2025100
202670
FIG. 1 — Lineage of K051219, 1997–2026Source: 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? (2)

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
*K971723Fastak Suture Anchor (11.7MM)/(7.5MM)
Summary page 1
…Fastener, Fixation, Biodegradable, Soft Tissue PREDICATE DEVICE: Bio-FASTak Suture Anchors: K971723 & K000506 DEVICE DESCRIPTION AND INTENDED USE: The Arthrex PushLockTM (suture anchor) is a 2 piece "push-in" anchor. The suture…
Arthrex, Inc.1997—
*K000506Bio-Fastak Suture Anchor, Model AR-1324B
Summary page 1
…Fastener, Fixation, Biodegradable, Soft Tissue PREDICATE DEVICE: Bio-FASTak Suture Anchors: K971723 & K000506 DEVICE DESCRIPTION AND INTENDED USE: The Arthrex PushLockTM (suture anchor) is a 2 piece "push-in" anchor. The suture anchor is…
Arthrex, Inc.2000—

Also cleared against K971723: 6 other devices →

What descends from it? (151)

See all 151

14 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.200864
K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.200650
K060914Trident AnchorJohnson & Johnson Company200633
K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div.201029
K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions20094
K091202Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying…Medshape Solutions20093
K203334The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc.20212
K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192
K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192
K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K073509 (Smith & Nephew, Inc., 2008) has gone furthest, with 64 descendants of its own.
  • 6 other devices also cite its predicate K971723.

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.

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 PushLockTM is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, 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, Hallux Valgus Reconstruction…

Read the full statement (121 words)

The Arthrex PushLockTM is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair

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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Indications for use as stated in the FDA summary.

Also cleared against K971723

6 other devices cite the same predicate.

  • K082729Rimclose Bone AnchorAnulex Technologies, Inc. · 2008
  • K072063KFX Tissue Fixation System and AccessoriesKfx Medical · 2007
  • K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  • K070882Stryker Peek Twinloop TacStryker Endoscopy · 2007
  • K050358Artherx Corkscrew FT II Suture AnchorArthrex, Inc. · 2005
  • K990361Headed Bio-Absorbable Corkscrew Model #AR-1921BUArthrex, Inc. · 1999

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • 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
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K051219 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051219: Pushlock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051219

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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