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J-FX Bipolar Head

by Johnson & Johnson Professionals, Inc.

510(k) K980801

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 NumberK980801 Date29 May 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  • Withdrawn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
KWY
Device Class
Class II
Regulation
21 CFR Part 888.3390
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 J-FX Bipolar Head is a metal‑polymer femoral head endoprosthesis intended for partial hip replacement surgery. It is designed to replace the femoral head in patients with conditions such as femoral fracture, avascular necrosis, osteoarthritis or other abnormalities affecting the femoral head.

The device consists of a cobalt‑chrome alloy shell conforming to ASTM F75 and a UHMWPE liner assembly that includes a bearing insert, inner retaining ring and outer locking ring. It is identified by FDA 510(k) clearance (K980801), product code KWY, and was cleared on 29 May 1998. The component is supplied by Johnson & Johnson Professionals, Inc. for use in orthopedic procedures and may be implanted cemented or uncemented as required.

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