FDA applicant

Medshape Solutions

Atlanta, GA6 decisions2009–20111 recall

FDA records 6 decisions for Medshape Solutions (Atlanta, GA) from 2009 to 2011: 6 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 12 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Medshape Solutions, Inc.”.

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 Solutions’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2009high 3 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2013

2009high 1 (2013) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Medshape Solutions by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medshape Solutions’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, Inc. 17

Medshape Solutions

Which product codes does it file in?

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”