Question 1

What types of medical devices does Healthium MedTech Limited manufacture?

Accepted Answer

Healthium MedTech Limited specialises in sutures, including bioabsorbable polyester (both monofilament and multifilament), non-antimicrobial silk, and non-bioabsorbable nylon and polyolefin/fluoropolymer sutures. The company also produces synthetic polymer surgical mesh for extra-gynaecological procedures, meniscus suture anchors, and skin-closing tension devices. These products are designed for surgical applications requiring precise tissue approximation or reinforcement.

Question 2

Where is Healthium MedTech Limited based?

Accepted Answer

Healthium MedTech Limited is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory frameworks, including those governing medical device authorisation.

Question 3

Which regulatory registries or databases list Healthium MedTech Limited’s devices?

Accepted Answer

Healthium MedTech Limited’s devices are authorised through the FDA’s 510(k) clearance process and are assigned Unique Device Identification (UDI) numbers. These registries ensure traceability and compliance tracking for Class II devices, which include sutures, surgical mesh, anchors, and tension devices.

Question 4

How are Healthium MedTech Limited’s devices classified under FDA regulations?

Accepted Answer

All of Healthium MedTech Limited’s devices fall under FDA Class II classification. This category applies to moderate-risk devices that require special controls beyond general controls to ensure safety and effectiveness. Class II devices are authorised via 510(k) clearances, demonstrating that they meet regulatory standards for their intended use.

Question 5

What distinguishes Healthium MedTech Limited’s suture products from others in the market?

Accepted Answer

Healthium MedTech Limited’s suture portfolio includes a variety of materials and configurations, such as bioabsorbable polyester (monofilament/multifilament), non-antimicrobial silk, and non-bioabsorbable nylon/polyolefin sutures. The company also offers specialised products like meniscus suture anchors and skin-closing tension devices, catering to specific surgical needs where tissue strength, absorption rates, or handling properties are critical. These distinctions help surgeons select sutures tailored to procedural requirements.

Device	Model / Reference	Registries	Class	Status
Truglyde	MU250298	FDA UDI	Class II	Active
Trusynth	10F70DZ26	FDA UDI	Class II	Active
Trulene	8I45CX13	FDA UDI	Class II	Active
PD Synth	9E70DZ26	FDA UDI	Class II	Active
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-Right	S29-1802-TQ	FDA UDI	Class II	Active
Monoglyde	11F90CY19	FDA UDI	Class II	Active
Surgical Mesh	TVM151-IB	FDA UDI	Class II	Active
Monoglyde	ED250205	FDA UDI	Class II	Active
Trulon	3I45CX11	FDA UDI	Class II	Active
Trusynth	10E70DZ26	FDA UDI	Class II	Active
Trusilk	5G45CX16	FDA UDI	Class II	Active
Truglyde	2E70DZ30	FDA UDI	Class II	Active
Trusynth	10C70DZ36H	FDA UDI	Class II	Active
Monoglyde	11G90CX13	FDA UDI	Class II	Active
Trulon	3E75AX60	FDA UDI	Class II	Active
Trusynth	10D75DZ26	FDA UDI	Class II	Active
Trubond	ED250209	FDA UDI	Class II	Active
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant	K230891	FDA 510(k)	Class II	Active
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button	K232886	FDA 510(k)	Class II	Active
CEPTRE® Knotted UHMWPE Suture PEEK Anchor	K231033	FDA 510(k)	Class II	Active
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button	K231404	FDA 510(k)	Class II	Active
Stativ® Knotted UHMWPE Suture Anchor	K223889	FDA 510(k)	Class II	Active

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