Jaykay Enterprises Limited disclosed pursuant to Regulation 30 of SEBI Listing Regulations that its wholly owned subsidiary, JK Digital & Advance Systems Private Limited (JK Digital), has received a Licence to Manufacture for Sale or for Distribution of Class C or Class D Medical Devices from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Licence Details
- Licence Number: MFG/MD/2026/000784
- Issue Date: October 21, 2026
- Validity: Lifetime
- Governing Regulations: Medical Devices Rules, 2017
Licensed Products
The licence covers eight categories of advanced medical implants manufactured using titanium alloy powder (Ti6Al4V) under the brand names Neobone and Nubone:
1. Lattice Acetabular Cups: For complex hip revision surgeries and reconstruction of severe acetabular bone defects
2. Lattice Cone Acetabular Cups: For complex hip revision surgeries and reconstruction of severe acetabular bone defects
3. Lattice Buttress Implants: To provide structural support during revision total hip arthroplasty
4. Lattice Shim Implants: For structural gap-filling and angular adjustment in hip reconstruction procedures
5. Lattice Cage Constructs: For reconstruction of severe acetabular bone defects in complex primary or revision hip replacement procedures
6. Lattice TLIF Spinal Implants: Implants used in transforaminal lumbar interbody fusion procedures
7. Lattice PLIF Spinal Implants: Implants used in posterior lumbar interbody fusion procedures
8. Lattice Shells and Wedges: For augmentation, reconstruction and reinforcement of acetabular bone during complex hip replacement procedures
Manufacturing Location
The licensed manufacturing premises are located at: FIRST AND SECOND FLOOR, PLOT 477B, 4TH PHASE PEENYA INDUSTRIAL AREA, 12TH CROSS, BENGALURU, BENGALURU URBAN, KARNATAKA, 560058
Licence Conditions
The licence is subject to 12 specific conditions including:
- Production of licence upon request by Medical Device Officers
- Reporting of serious adverse events within 15 days
- Prior approval required for major changes
- Notification of minor changes within 30 days
- Batch testing compliance before release
- Product recall if directed by licensing authority
- Maintenance of audit/inspection books
- Sample retention for 180 days post-expiry
- Maintenance of manufacturing and sales records
- Inclusion of package inserts/user manuals
- Supervision by competent technical staff
- Intimation of manufacturing stoppage exceeding 30 days
Product Specifications
The annexure provides detailed specifications for all eight product categories with multiple model numbers, sizes, dimensions, and intended uses. All products have a shelf life of 2 years and are sterilized.
Impact Assessment
The receipt of this licence marks an important regulatory milestone for JK Digital and establishes regulatory authorisation to manufacture the specified specialised orthopaedic and spinal implant products. This development strengthens Jaykay Enterprises Limited's presence in the specialised medical devices segment and provides a regulatory foundation for pursuing opportunities in advanced orthopaedic and spinal implant solutions.