FDA applicant

Protek, Inc.

Indianapolis, IN25 decisions1985–19891 recall

FDA records 25 decisions for Protek, Inc. (Indianapolis, IN) from 1985 to 1989: 25 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and KWA (Prosthesis, Hip, Semi-Constrained (Metal…). 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 Protek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Protek, Inc. since 2007.

Recalls per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Protek”

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

Protek Medical Products, Inc. 9

Protek, Inc.

Which product codes does it file in?

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 “Protek”