Pioneering Orthopedic Excellence Since 1992

Sharma Orthopedic India Limited has grown from a specialized manufacturing unit into a global healthcare leader. For over 30 years, our relentless commitment to medical-grade precision, certified quality management (ISO 13485, MDSAP), and clinical collaboration has powered surgical success across 50+ nations worldwide.

Milestones & Technological Evolution

1992 – 2000

Foundation & Trauma Care Pioneers

  • 1992: Established as a dedicated family enterprise producing premium bone screws and trauma plates.
  • 1993–1998: Engineered advanced interlocked intramedullary nail systems for comprehensive trauma care.
  • 2000: Became the first Indian orthopedic manufacturer to launch specialized locking plate systems.
2006 – 2010

Corporate Restructuring & Global Footprint

  • 2006: Incorporated as Sharma Ortho System Pvt. Ltd. to support enterprise-level manufacturing.
  • 2007: Secured CDSCO regulatory approvals, expanding national hospital supply networks.
  • 2009: Initiated international export operations, penetrating key Latin American medical markets.
2010 – 2014

High-Precision Automation & Arthroplasty R&D

  • 2011: Integrated 5-axis CNC machining centers and Swiss-Turn automated production lines.
  • 2013: Successfully developed proprietary Total Hip and Total Knee Replacement systems.
2014 – 2018

Joint Replacement Leadership & National Recognition

  • 2014: Rebranded to Sharma Orthopedic (India) Pvt. Ltd., consolidating operations.
  • 2016: Launched the flagship ENTICE Total Knee Replacement System globally.
  • 2018: Honored with the EEPC India Star Performer Award for export dominance in medical devices.
2019 – 2023

Facility Expansion & Direct Overseas Presence

  • 2019: Merged corporate operations into a unified entity for maximum operational efficiency.
  • 2021: Added 9,000 sq. ft. of cleanroom facilities at our Waghodia, Gujarat manufacturing campus.
  • 2023: Established direct overseas distribution offices in Colombia, Guatemala, and Malaysia.
2024

MDSAP Certification & Next-Gen Implants

  • ENTICE II PS Knee: Launched the High-Flex Knee System, gaining clinical adoption across 22+ countries.
  • MDSAP Approval: Achieved Medical Device Single Audit Program certification for multi-market regulatory clearance.
2025

Revision Systems & Capital Investment

  • Complex Revision Solutions: Commercialized Revision Knee, Modular Hip Revision, and Dual Mobility Cup Systems.
  • Infrastructure Growth: Invested $1.2M USD (₹12 Crore) to commission 20+ automated CNC machine units.
2026 & Beyond

Global Market Leadership & USFDA Filing

  • Hinged Knee System: Commercial release of advanced hinged knee implants for complex primary reconstruction.
  • ZED Gold Rating: Awarded ZED Gold Certification by the Government of India for manufacturing excellence.
  • USFDA Submissions: Initiated 510(k) clearances for joint replacement and interlocking nail portfolios.

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