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CLS Brevius Stem with Kinectiv Technology

by Zimmer GmbH

510(k) K110836

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110836 Date7 Oct 2011ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0319-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K110836

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

  1. Cleared FDA 510(k) K110836
  2. Recall initiated FDA recalls Z-0319-2020

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  • Withdrawn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
KWA
Device class
Class III
Regulation
21 CFR Part 888.3330
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 CLS Brevius Stem with Kinectiv Technology is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for primary total hip arthroplasty. This modular femoral stem features Kinectiv Technology, integrating with Zimmer’s modular neck system to enhance anatomical fit and stability in hip replacement procedures.

Intended for uncemented use, the device is supplied as a reusable surgical implant and is regulated under FDA 510(k) clearance (K110836). It is classified as a Class III medical device under the FDA’s regulatory framework, with multiple FEI numbers (e.g., 3020282716) and registration numbers (e.g., 8043792) associated with its variants. Storage and handling follow standard orthopedic implant protocols, adhering to manufacturer guidelines for sterility and surgical preparation.

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