510(k) Report

FDA applicant

Accin Corporation

Clifton, NJ2 decisions2006–20071 recall

FDA records 2 decisions for Accin Corporation (Clifton, NJ) from 2006 to 2007: 2 510(k) clearances. All are in product code HSX (Prosthesis, Knee, Femorotibial…). Its devices cite 5 predicates, 1 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 Accin Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Accin Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Accin Corporation’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

Which product codes does it file in?

  • HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K060670Accin Uni-Knee SystemAccin Corporation · 20065cite it
  • K063782Accin Uni-Knee SystemAccin Corporation · 20072cite it

What has FDA decided for it lately?

  • K063782Accin Uni-Knee SystemAccin Corporation · 2007
  • K060670Accin Uni-Knee SystemAccin Corporation · 20061 recall

All 2 as Accin Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060670iBalance (R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC…Oct 3, 2017Class II