FDA applicant

MedShape, Inc.

Atlanta, GA17 decisions2012–20261 recall

FDA records 17 decisions for MedShape, Inc. (Atlanta, GA) from 2012 to 2026: 17 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and JDR (Staple, Fixation, Bone). Since 2016 its 510(k)s took a median of 146 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 40 predicates, 18 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 MedShape, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012high 3 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2021

2012high 1 (2021) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — MedShape, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like MedShape, 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

Other applicant names beginning “MedShape”

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

Medshape Solutions 6

MedShape, Inc.

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 “MedShape”