510(k) Report

FDA applicant

Arthrotek, Inc.

Warsaw, IN17 decisions1987–20067 recalls

FDA records 17 decisions for Arthrotek, Inc. (Warsaw, IN) from 1987 to 2006: 17 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 35 predicates, 4 of them its own earlier devices. 7 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 Arthrotek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arthrotek, Inc. since 2007.

Recalls per year

4in 2018

2008: 22015: 12018: 4
2007high 4 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Arthrotek, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HWCScrew, Fixation, Bone4decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue4decisions
  • JDRStaple, Fixation, Bone4decisions
  • HTYPin, Fixation, Smooth2decisions
  • NFQDevice, Dental Sonography, For Monitoring Jaw Sounds1decision
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene1decision

Also: GCJ (1).

Whose devices does it build on?

Its devices cite 35 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 4 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.

  • K060693Microstrike and Allthread Peek Suture AnchorArthrotek, Inc. · 20066cite it
  • K041274Resorbable Interference ScrewArthrotek, Inc. · 20046cite it
  • K012872Resorbable Screw AnchorArthrotek, Inc. · 20014cite it
  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 20062cite it
  • K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 20062cite it
  • K042460TI - Screw Anchor SPArthrotek, Inc. · 20042cite it

What has FDA decided for it lately?

  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
  • K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006
  • K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K061389Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K060693Microstrike and Allthread Peek Suture AnchorArthrotek, Inc. · 2006
  • K053461Ezloc Femoral Fixation DeviceArthrotek, Inc. · 2006
  • K051069Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc. · 2005
  • K042460TI - Screw Anchor SPArthrotek, Inc. · 2004

All 17 as Arthrotek, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K041274Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment…Mar 28, 2018Class II
  • K041274Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment…Mar 28, 2018Class II
  • K041274Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment…Mar 28, 2018Class II
  • K041274Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment…Mar 28, 2018Class II
  • K041274Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for…Jun 3, 2015Class II
  • K041261BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated…Apr 17, 2008

Other applicant names beginning “Arthrotek”

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

Arthrotek/Biomet, Inc. 1