Osstem

Also known as: Osstem Implant, Osstem TS

The principal implant brand of Osstem Implant of South Korea, whose TS line is its flagship implant family.

Key facts

Manufacturer	Osstem Implant Co., Ltd.Verified spec[1]
Parent company	Osstem Implant Co., Ltd., a private company since its 2023 KOSDAQ delistingVerified spec[1][3]
Country	South KoreaVerified spec[1]
Headquarters	Seoul, South Korea, with manufacturing centred on BusanVerified spec[1]
Founded	1997Verified spec[1]
Manufacturer-described indication	The TS implant is presented as the company’s flagship productManufacturer-reported[1]
Geographic availability	Sold through subsidiaries across more than 90 countriesManufacturer-reported[1]
manufacturingCountry	South KoreaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Osstem implants are among the most widely placed in the world by unit volume, and UK patients meet them most often in quotations for treatment in Turkey, Hungary or South Korea itself. The core range is the TS family. The most useful thing to know about the brand is that it also trades as Hiossen in the United States — same manufacturer, different name — so the two should not be compared as though they were competing products. Volume is a reasonable proxy for parts availability, but it is not evidence about clinical outcomes, which is a separate question answered by studies rather than sales figures.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance5 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

Number	Device	Holder	Date
K222778	Osstem Implant System	Osstem Implant Co., Ltd.	2023-09-23
K221684	Osstem Abutment System	Osstem Implant Co., Ltd.	2022-09-08
K182091	Osstem Abutment System	Osstem Implant Co., Ltd.	2019-07-12
K161689	OSSTEM Implant System - Abutment	Osstem Implant Co., Ltd.	2017-05-22
K161604	OSSTEM Implant System	Osstem Implant Co., Ltd.	2016-10-17

Other3 records

Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

Number	Device	Holder	Date
3031886796	—	OSSTEM IMPLANT CO., LTD.	—
3003394081	—	OSSTEM IMPLANT CO., LTD.	—
2157 device records	—	Osstem	—

Clearance records for Osstem were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Osstem.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]About us — Osstem Implant — Osstem Implant Co., Ltd.. Accessed 2026-07-21.
[2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.

Additional references

[3]Osstem Implant to be delisted from Kosdaq — The Korea Herald, 2023. Accessed 2026-07-21.