JEJaykay Enterprises500306Regulatory approval

Wholly owned subsidiary receives CDSCO licence to manufacture Class C/D orthopaedic and spinal implants

Jaykay's wholly owned subsidiary JK Digital has received a CDSCO manufacturing licence.

By ScoutQuest · Thu 22 Oct 2026, 11:13 AM IST · 2 min read

Licence No. & Date

Licence No. MFG/MD/2026/000784, dated 21 October 2026

Categories Covered

Covers eight categories of orthopaedic and spinal implants

Validity & Brands

Valid for a lifetime; brand names Neobone and Nubone, made from titanium alloy powder (Ti6Al4V)

What was announced

• JK Digital & Advance Systems Private Limited, described as a wholly owned subsidiary of the company, has received a Licence to Manufacture for Sale or for Distribution of Class C or Class D Medical Devices.
• The licence, bearing Licence No. MFG/MD/2026/000784 dated 21 October 2026, was issued by the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, under the Medical Devices Rules, 2017.
• The update states the licence is valid for a lifetime.

What the licence covers

• Eight categories of advanced medical implants in all.
• Hip reconstruction range: Lattice Acetabular Cups, Lattice Cone Acetabular Cups, Lattice Buttress Implants, Lattice Shim Implants, Lattice Cage Constructs, and Lattice Shells and Wedges — used in complex hip revision surgeries and reconstruction of severe acetabular bone defects.
• Spinal range: Lattice TLIF Spinal Implants (transforaminal lumbar interbody fusion) and Lattice PLIF Spinal Implants (posterior lumbar interbody fusion).
• The licensed devices are described as sterilized, with a shelf life of 2 years, made from titanium alloy powder (Ti6Al4V) and covered by the brand names Neobone and Nubone.

Where it will be made

• The licence names manufacturing premises at the First and Second Floor, Plot 477B, 4th Phase Peenya Industrial Area, 12th Cross, Bengaluru, Karnataka.

Conditions attached to the licence

• Each batch must be tested before release for compliance with specifications.
• Any suspected unexpected serious adverse event, including a recall, must be reported to the Central Licensing Authority within fifteen days.
• Prior approval is needed before any major change under the Sixth Schedule; minor changes must be intimated within thirty days.
• At least one unit of sample from each batch of invasive device must be kept for reference for one hundred and eighty days after the date of expiry of that batch.

How to read this

• The company describes the licence as an important regulatory milestone that establishes the regulatory authorisation to manufacture these specialised orthopaedic and spinal implant products, subject to the terms and conditions of the licence and applicable regulatory requirements.
• In simple terms, this is a permission to manufacture and sell these devices in India. It is a regulatory clearance, and the update presents it as strengthening the company's presence in the specialised medical devices segment.
• The update sets out the scope of the authorisation and the licence conditions; the commercial scale of this business is not part of what the company has stated here.

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