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Zimmer Biomet Select Ceramic Heads

by Zimmer, Inc.

510(k) K181761

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 NumberK181761 Date26 Dec 2018ClearedStatusActive

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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
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 Zimmer Biomet Select Ceramic Heads are prostheses used in hip replacement surgery. They are designed to replace the femoral head in patients with severely painful or disabled hip joints due to conditions such as osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, or acute traumatic fracture of the femoral head or neck.

These ceramic heads are supplied as part of a hip prosthesis system and are available in various sizes. The device is intended for use in orthopedic procedures and has received FDA 510(k) clearance as substantially equivalent to predicate devices. The product is classified under product code LZO and regulation 888.3353 for Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented.

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Questions

AI-generated answers, 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.

  • What are Zimmer Biomet Select Ceramic Heads used for?

    These ceramic heads are prostheses designed to replace the femoral head in hip replacement surgery for patients with severely painful or disabled hip joints due to conditions like osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, or acute traumatic fracture of the femoral head or neck.

  • What sizes are available for the Zimmer Biomet Select Ceramic Heads?

    The Zimmer Biomet Select Ceramic Heads are supplied in various sizes to accommodate different patient anatomies and surgical requirements, though specific size ranges are not detailed in the provided information.

  • What is the regulatory status of the Zimmer Biomet Select Ceramic Heads?

    The Zimmer Biomet Select Ceramic Heads have received FDA 510(k) clearance as substantially equivalent to predicate devices, classified under product code LZO and regulation 888.3353 for Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented.

  • How are the Zimmer Biomet Select Ceramic Heads supplied?

    The Zimmer Biomet Select Ceramic Heads are supplied as part of a hip prosthesis system, though the specific packaging, sterility status, and whether they are single-use or reusable devices are not detailed in the provided information.