FDA applicant

Ascension Orthopedic

Austin, TX7 decisions2011–20143 recalls

FDA records 7 decisions for Ascension Orthopedic (Austin, TX) from 2011 to 2014: 7 510(k) clearances. Most are in product codes KWS (Prosthesis, Shoulder, Semi-Constrained…) and HRS (Plate, Fixation, Bone). Its devices cite 14 predicates, 0 of them its own earlier devices. 3 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 Ascension Orthopedic’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011high 2 (2011) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

3in 2016

2011high 3 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Ascension Orthopedic by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ascension Orthopedic’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 “Ascension”

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

Ascension Orthopedics, Inc. 29

Ascension Orthopedic

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 “Ascension”