510(k) Report

FDA applicant

Subchondral Solutions, Inc.

Los Gatos, CA3 decisions2017–20220 recalls

FDA records 3 decisions for Subchondral Solutions, Inc. (Los Gatos, CA) from 2017 to 2022: 3 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 267 days from receipt to decision, against 75 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Subchondral Solutions”.

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

FDA decisions per year

1in 2022

2017: 12020: 12022: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Subchondral Solutions, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Subchondral Solutions, Inc.’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, Bone2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 267 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 75 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K162171S4 Screw System™Subchondral Solutions · 20172cite it
  • K191995S4 Screw SystemSubchondral Solutions, Inc. · 20202cite it

What has FDA decided for it lately?

  • K220901S-Core Implant SystemSubchondral Solutions, Inc. · 2022
  • K191995S4 Screw SystemSubchondral Solutions, Inc. · 2020
  • K162171S4 Screw System™Subchondral Solutions · 2017

All 2 as Subchondral Solutions, Inc. →The one decision as Subchondral Solutions →