FDA applicant

Gramercy Extremity Orthopedics, LLC

Richardson, TX5 decisions2019–20211 recall

FDA records 5 decisions for Gramercy Extremity Orthopedics, LLC (Richardson, TX) from 2019 to 2021: 5 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 of them its own earlier devices. 1 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 Gramercy Extremity Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2019high 2 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2023

2019high 1 (2023) · low 0 (2019)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Gramercy”

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

Gramercy Extremity Orthopeidics, LLC 1

Gramercy Extremity Orthopedics, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Gramercy”