510(k) Report

FDA applicant

Arthrex, Inc.

Naples, FL355 decisions1992–202613 recalls

FDA records 355 decisions for Arthrex, Inc. (Naples, FL) from 1992 to 2026: 355 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 603 predicates, 408 of them its own earlier devices. 13 recalls are linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Arthrex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

21in 2025

2007: 82008: 42009: 62010: 62011: 112012: 72013: 102014: 122015: 132016: 112017: 102018: 162019: 192020: 262021: 112022: 172023: 182024: 102025: 212026 (partial year): 17
2007high 26 (2020) · low 4 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2021

2016: 22017: 62018: 12019: 12020: 12021: 2
2007high 6 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Arthrex, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue52decisions
  • HWCScrew, Fixation, Bone47decisions
  • MAIFastener, Fixation, Biodegradable, Soft Tissue46decisions
  • HRSPlate, Fixation, Bone39decisions
  • HRXArthroscope27decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene19decisions

Also: HTN (16), KWS (15), HTY (13), PHX (11), GCJ (9), JDR (6).

How long do its 510(k) reviews take?

Since 2016, its 165 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 94 days; 87 of its 165 were faster than that.

Whose devices does it build on?

Its devices cite 603 predicates; 408 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 905 times; 408 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 200634cite it
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DSArthrex, Inc. · 200526cite it
  • K103705Low Profile ScrewsArthrex, Inc. · 201122cite it
  • K101679Arthrex Pushlock AnchorsArthrex, Inc. · 201021cite it
  • K063479Arthrex PushlockArthrex, Inc. · 200617cite it
  • K050259Arthrex Bio-PinArthrex, Inc. · 200516cite it

What has FDA decided for it lately?

  • 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
  • K260018Arthrex FiberButtonArthrex, Inc. · 2026
  • K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026

All 355 as Arthrex, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K203495Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCCJun 14, 2021Class II
  • K032187Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in…Mar 11, 2021Class II
  • K141478Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product…Jun 24, 2020Class II
  • K141735Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used…Oct 1, 2019Class II
  • K180118Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled…Nov 19, 2018Class II
  • K101823Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-PunchingMar 24, 2017Class II

Other applicant names beginning “Arthrex”

FDA records each applicant name separately; these may or may not be the same firm.

Arthrex Arthroscopy Instruments, Inc. 2