# Healthium Medtech Limited

- Location (FDA's records): Bangalore, IN
- FDA decisions: 5 (2023–2024): 5 510(k) clearances
- Product codes: MBI (5)
- 510(k) review time since 2016: median 85 days, against 57 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Aju Pharm Co., Ltd.: 1 (https://510kreport.com/company/aju-pharm)
- Conmed Linvatec: 1 (https://510kreport.com/company/conmed-linvatec)
- Depuy Mitek, A Johnson & Johnson Company: 1 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)

## Recent decisions
- K231033: CEPTRE® Knotted UHMWPE Suture PEEK Anchor (Jan 4, 2024)
- K230891: SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant (Dec 28, 2023)
- K232886: INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (Nov 8, 2023)
- K231404: T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (Aug 4, 2023)
- K223889: Stativ® Knotted UHMWPE Suture Anchor (Mar 22, 2023)

Source page: https://510kreport.com/company/healthium-medtech