510(k) Report

510(k) · Cleared

Cleared

Arthrex Pushlock

K063479510(k) SpecialCleared Dec 13, 200626-day reviewClass II21 CFR 888.3040

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

Arthrex, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 13, 2006 as substantially equivalent to K050749 (Arthrex, Inc., 2005) after a 26-day review. Its family tree reaches back 1 generation to 2005. 97 later devices descend from it.

Decided
Dec 13, 2006
Review
26 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K050749 (2005). 97 later devices descend from it, 17 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2010: 1 descendant cleared2014: 3 descendants cleared2018: 6 descendants cleared2015: 5 descendants cleared2017: 3 descendants cleared2023: 13 descendants cleared2011: 2 descendants cleared2025: 15 descendants cleared2019: 5 descendants cleared2024: 7 descendants cleared2026: 16 descendants cleared2012: 1 descendant cleared2020: 9 descendants cleared2016: 3 descendants cleared2022: 3 descendants cleared2021: 3 descendants clearedK050749 · Arthrex Tak Family · Arthrex, Inc. · 200520052010201520202025
Descendants, by generation 1 generation forward: 17 descendants2 generations forward: 14 descendants3 generations forward: 19 descendants4 generations forward: 20 descendants5 generations forward: 8 descendants6 generations forward: 8 descendants7 generations forward: 6 descendants8 generations forward: 5 descendants K050749 · Arthrex Tak Family · Arthrex, Inc. · 20050+5
  1. Root · 1 generation backK050749 Arthrex Tak FamilyArthrex, Inc. · 2005
  2. This deviceK063479 Arthrex PushlockArthrex, Inc. · 2006
  3. Descendant · cites it directly · 77 of its ownK112237 Microsuture AnchorsArthrex, Inc. · 2011
  4. Descendant · 2 generations on · 63 of its ownK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
  5. Descendant · 2 generations on · 29 of its ownK140476 Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014
  6. Descendant · 3 generations on · 27 of its ownK151230 Arthrex FiberTak AnchorsArthrex, Inc. · 2015
  7. Descendant · 3 generations on · 24 of its ownK181769 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2009: 22010: 12011: 22012: 12014: 32015: 52016: 32017: 32018: 62019: 52020: 92021: 32022: 32023: 132024: 72025: 152026: 16
2009high 16 (2026) · low 0 (2013)2026

Most influential descendants

Showing 5 of 97 · See all
  • K112237Microsuture AnchorsArthrex, Inc. · 2011 · cites it directly77descendants
  • K140855Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014 · 2 generations on63descendants
  • K140476Arthrex Fibertak Suture AnchorArthrex, Inc. · 2014 · 2 generations on29descendants
  • K151230Arthrex FiberTak AnchorsArthrex, Inc. · 2015 · 3 generations on27descendants
  • K181769Arthrex FiberTak Suture AnchorArthrex, Inc. · 2018 · 3 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K050749Arthrex Tak FamilyArthrex, Inc.2005—
0 (this device)K063479Arthrex PushlockArthrex, Inc.2006—
+1K112237Microsuture AnchorsArthrex, Inc.2011—
+2K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.2014—
+2K140476Arthrex Fibertak Suture AnchorArthrex, Inc.2014—
+3K151230Arthrex FiberTak AnchorsArthrex, Inc.2015—
+3K181769Arthrex FiberTak Suture AnchorArthrex, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201010
201120
201210
201430
201550
201630
201730
201860
201950
202090
202130
202230
2023130
202470
2025150
2026160
FIG. 1 — Lineage of K063479, 2005–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K050749Arthrex Tak Family
Summary page 1
…Fastener, Fixation, Biodegradable, Soft Tissue Predicate Device Tak Family Suture Anchors: K050749 Device Description and Intended Use The Arthrex PushLockTM (suture anchor) is a 2 piece "push-in" anchor. The suture anchor is de…
Arthrex, Inc.2005—

Also cleared against K050749: 4 other devices →

What descends from it? (97)

See all 97

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

NumberDeviceApplicantDecidedDescendants
K112237Microsuture AnchorsArthrex, Inc.201177
K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252
K171228Fiji AnchorSportwelding GmbH20182
K173240Arthrex PushLockArthrex, Inc.20182
K133235Threaded Peek K-WireMtp Solutions, LLC20142
K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092
K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261
K240288SF Push- in AnchorSurgical Fusion Technologies GmbH20241
K143063Stryker SonicPin System, Stryker SonicAnchor SystemStryker Trauma GmbH20151
K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250

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?

  • Its one ancestor has no recall.
  • Of its descendants, K112237 (Arthrex, Inc., 2011) has gone furthest, with 77 descendants of its own.
  • 4 other devices also cite its predicate K050749.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Arthrex PushLockTM 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…

Read the full statement (173 words)

The Arthrex PushLockTM 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

Indications for use as stated in the FDA summary.

Also cleared against K050749

4 other devices cite the same predicate.

  • K153585Flip Button Suture AnchorFirst Ray, LLC · 2016
  • K133229Titanium Suture AnchorMtp Solutions, LLC · 2014
  • K0815112.0 PK Suture Anchor T, 2.0 PK Suture Anchor SSmith & Nephew, Inc. · 2008
  • K070882Stryker Peek Twinloop TacStryker Endoscopy · 2007

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

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The HWC category page

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https://510kreport.com/device/K063479 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063479: Arthrex Pushlock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063479

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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