510(k) Report

FDA applicant

Crossroads Extemity Systems, LLC

Memphis, TN3 decisions2019–20200 recalls

FDA records 3 decisions for Crossroads Extemity Systems, LLC (Memphis, TN) from 2019 to 2020: 3 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is 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 Crossroads Extemity Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 22020: 1
2019high 2 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Crossroads Extemity Systems, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JDRStaple, Fixation, Bone1decision
  • HWCScrew, Fixation, Bone1decision
  • HRSPlate, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 91 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 20201cites it

What has FDA decided for it lately?

  • K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
  • K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC · 2019
  • K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC · 2019

All 3 as Crossroads Extemity Systems, LLC →

Other applicant names beginning “Crossroads”

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

Crossroads Extremity Systems, LLC 16Crossroads Neurovascular, Inc. 2Crossroads Distribution Company, LLC 1Crossroads Trading Co. 1