510(k) Report

FDA applicant

Reiley Orthopaedics, Inc.

Round Rock, TX1 decision2005–20052 recalls

FDA records 1 decision for Reiley Orthopaedics, Inc. (Round Rock, TX) in 2005: 1 510(k) clearance. All are in product code HWC (Screw, Fixation, Bone). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 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 Reiley Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Reiley Orthopaedics, Inc. since 2007.

Recalls per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Reiley Orthopaedics, 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?

  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 20051cites it

What has FDA decided for it lately?

  • K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 20052 recalls

The one decision as Reiley Orthopaedics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K051309ENDO-FUSE (TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF…Apr 20, 2011
  • K051309ENDO-FUSE (TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF…Apr 20, 2011