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Osteotec, Ltd.

Last updated May 24, 2026

What Osteotec, Ltd. makes

Osteotec, Ltd. manufactures reusable orthopaedic instruments and components for hand surgery, including bone files, rasps, and awls designed for distal and proximal phalanges. Their portfolio also includes trial implants, sizers, and holders for metacarpophalangeal and proximal interphalangeal joint prostheses, as well as osteotomy guides and counter-torque instruments for bone manipulation. Additional products feature reusable bone trephines and instrument trays for surgical procedures.

The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and Unique Device Identification (UDI) databases. Their products are intended for use in the United States, where regulatory compliance aligns with FDA requirements for medical device authorisation.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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Catalogue (70)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Osteotec CBG Tray, empty	OST-CGB-TRAY	FDA UDI	Class I	Active
Osteotec Silicone Finger - Proximal Rasp Size 00	OSTF-00P	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 9	OSTF-9D	FDA UDI	Class I	Active
Osteotec Silicone Finger - Small Rasp Tray, empty	OSTF-INS6	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 3	OSTF-3D	FDA UDI	Class I	Active
Osteotec Silicone Finger - Distal Rasp Size 2	OSTF-2D	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 2	OSTF-2	FDA UDI	Class II	Active
Osteotec CBG Spike L	OST-CBG-17	FDA UDI	Class I	Active
Osteotec Silicone Finger - Proximal Rasp Size 6	OSTF-6P	FDA UDI	Class I	Active
Osteotec CBG Ejector L	OST-CBG-19	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant Sizer Size 00	OSTF-S00	FDA UDI	Class I	Active
Osteotec CBG Tube Saw L - size 8	OST-CBG-08	FDA UDI	Class I	Active
Osteotec Silicone Finger - Proximal Rasp Size 1	OSTF-1P	FDA UDI	Class I	Active
Osteotec CBG Tube Saw L - size 6	OST-CBG-06	FDA UDI	Class I	Active
Osteotec CBG Soft Tissue Displacer Small	OST-CBG-20	FDA UDI	Class I	Active
Osteotec CBG Soft Tissue Displacer Large	OST-CBG-22	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant - Size 4	OSTF-4	FDA UDI	Class II	Active
Osteotec Silicone Finger - Proximal Rasp Size 5	OSTF-5P	FDA UDI	Class I	Active
Osteotec CBG Tube Saw L - size 7	OST-CBG-07	FDA UDI	Class I	Active
Osteotec Silicone Finger Implant	K140453	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Osteotec, Ltd. has one FDA recall record initiated on June 18, 2025. The recall is listed with both open and classified statuses. The reason stated is the potential presence of foreign material in the silicone implant.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 18, 2025	Z-2222-2025	—	open, classified	There is the potential that the silicone implant may contain foreign material