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Oti Femoral Lock Total Hip System

by Osteoimplant Technology, Inc.

510(k) K982598

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982598 Date2 Oct 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Oti Femoral Lock Total Hip System is a semi-constrained, metal/polymer, cemented hip prosthesis. It is indicated for use in total or partial hip replacement procedures for patients experiencing severe pain and disability caused by structural damage in the hip joint. This damage may result from conditions such as rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, or femoral non-union.

This device is authorized under FDA 510(k) clearance K982598. It is manufactured by Osteoimplant Technology, Inc. and is categorized under the orthopedic product code JDI.

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