Question 1

What types of medical devices does Groupe Lepine manufacture?

Accepted Answer

Groupe Lepine specialises in non-adjustable orthopaedic bone staples. These devices are specifically designed for internal fixation of bone fractures, helping to stabilise bone fragments during the healing process. The staples are intended for surgical use in long bones and joints.

Question 2

Where is Groupe Lepine based, and what does this mean for its regulatory compliance?

Accepted Answer

Groupe Lepine is based in France, which means its devices are subject to European Union regulations, including the EU Medical Device Regulation (MDR). This compliance framework ensures that the company’s products meet strict safety, performance, and quality standards before being authorised for use in the EU market.

Question 3

Which regulatory registries list Groupe Lepine’s devices?

Accepted Answer

Groupe Lepine’s devices are listed in multiple regulatory databases, including the EUDAMED system for EU market surveillance, the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) registry. These registries help ensure transparency and traceability of the company’s authorised products.

Question 4

How are Groupe Lepine’s orthopaedic bone staples classified under medical device regulations?

Accepted Answer

Groupe Lepine’s non-adjustable orthopaedic bone staples are classified as Class I or Class II/IIa devices. The classification determines the regulatory pathway and scrutiny required for authorisation. Class I devices generally pose minimal risk, while Class II/IIa devices require additional evidence of safety and performance due to their slightly higher risk profile.

Device	Model / Reference	Registries	Class	Status
Memodyn staples	CSU88	FDA UDI	Class II	Active
Memodyn staples	CSU1410	FDA UDI	Class II	Active
Memodyn staples	CSU1515	FDA UDI	Class II	Active
Memodyn staples	CSU1010	FDA UDI	Class II	Active
Memodyn staples	CSU99	FDA UDI	Class II	Active
Memodyn staples	CSU1210	FDA UDI	Class II	Active
Memodyn staples	CSU2020	FDA UDI	Class II	Active
Memodyn staples	CSU12(1315)	FDA UDI	Class II	Active
Memodyn staples	CSU2015	FDA UDI	Class II	Active
Memodyn staples	CSU1110	FDA UDI	Class II	Active
Memodyn staples	CSU1610	FDA UDI	Class II	Active
Memodyn staples	CSU751.2X1.2	FDA UDI	Class II	Active
Eis Threaded Screw Fracture Fixation	K991964	FDA 510(k)	Class II	Active
Eis Dynamic Memory Staples System	K991962	FDA 510(k)	Class II	Active
B2c Hip System	K992490	FDA 510(k)	Class II	Active
Pin With Eye Ø2.5 L435	BC2,5*435	EUDAMED	Class I	Active
Kirschner 1 Trocar Ø2.5 L300	BK2,5*300	EUDAMED	Class I	Active
Pin With Eye Ø2.5 L350	BC2,5*350	EUDAMED	Class I	Active
Transtibial Guide	GT2,5-7	EUDAMED	Class I	Active
Trial Head 36 0	HTA CM436	EUDAMED	Class IIa	Active
Drill Guide	HIA GV002	EUDAMED	Class I	Active
Hexagonal Screwdriver 3.5	OTA CR022	EUDAMED	Class I	Active
Cadran Screwdriver Hex 3.5	A011 6040	EUDAMED	Class I	Active
Cardan Screwdriver Hex 3.5	HL1300-010	EUDAMED	Class I	Active

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