# Meril Healthcare Pvt., Ltd.

- Location (FDA's records): Vapi, IN
- FDA decisions: 7 (2017–2023): 7 510(k) clearances
- Product codes: JWH (3), LPH (2), HRS (1), LZO (1)
- 510(k) review time since 2016: median 211 days, against 111 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 46 (3 its own); citations of its devices by later devices: 6 (3 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
- Synthes (Usa): 15 (https://510kreport.com/company/synthes-usa)
- Corin USA: 5 (https://510kreport.com/company/corin-usa)
- Biomet Manufacturing Corp: 4 (https://510kreport.com/company/biomet-manufacturing)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet, Inc.: 3 (https://510kreport.com/company/biomet)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Meril Healthcare Private Limited: 2 (https://510kreport.com/company/meril-healthcare-private)
- Howmedica Corp.: 2 (https://510kreport.com/company/howmedica)

## Firms that cite its devices most
- Signature Orthopaedic Pty, Ltd.: 1 (https://510kreport.com/company/signature-orthopaedic)
- Skeletal Dynamics, Inc.: 1 (https://510kreport.com/company/skeletal-dynamics)
- Maxx Orthopedics, Inc.: 1 (https://510kreport.com/company/maxx-orthopedics)

## Its most-cited devices
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (2018), cited by 2
- K172857: Latitud Hip Replacement System (2018), cited by 2
- K172936: Destiknee™ Total Knee System (2017), cited by 1
- K212839: Opulent TiNbN Coated Knee (2021), cited by 1

## Recent decisions
- K222436: Latitud™ Hip Replacement System (May 9, 2023)
- K222816: Opulent TiNbN Coated Knee (Nov 18, 2022)
- K212839: Opulent TiNbN Coated Knee (Nov 16, 2021)
- K183532: Latitud Hip Replacement System (Jul 18, 2019)
- K172857: Latitud Hip Replacement System (Jul 19, 2018)
- K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws (Mar 8, 2018)
- K172936: Destiknee™ Total Knee System (Nov 30, 2017)

Source page: https://510kreport.com/company/meril-healthcare-pvt