510(k) Report

FDA applicant

Exsomed Corp.

Aliso Viejo, CA4 decisions2019–20220 recalls

FDA records 4 decisions for Exsomed Corp. (Aliso Viejo, CA) from 2019 to 2022: 4 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 53 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Exsomed Corporation”.

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

FDA decisions per year

1in 2022

2019: 22020: 12022: 1
2019high 2 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like Exsomed Corp.’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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Which product codes does it file in?

  • HWCScrew, Fixation, Bone3decisions
  • HRSPlate, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 53 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K183603INnate Cannulated Screw SystemExsomed Corporation · 20194cite it
  • K201430InFrame™ Cannulated Fixation SystemExsomed Corp. · 20201cites it

What has FDA decided for it lately?

  • K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp. · 2022
  • K201430InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
  • K192473Exsomed Wrist Plating SystemExsomed Corporation · 2019
  • K183603INnate Cannulated Screw SystemExsomed Corporation · 2019

All 2 as Exsomed Corp. →All 2 as Exsomed Corporation →

Other applicant names beginning “Exsomed”

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

Exsomed Holdings Company, LLC 1Exsomed Holding Company, LLC 1