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Patello-Femoral Wave (Kahuna) Arthroplasty System

by Arthrosurface, Inc.

510(k) K181280

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

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 · Special NumberK181280 Date14 Jun 2018ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1046-2023 FDA Class II initiated 22 Dec 2022
    • Ongoing Z-1047-2023 FDA Class II initiated 22 Dec 2022
    • Ongoing Z-1045-2023 FDA Class II initiated 22 Dec 2022

    The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.

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  • Withdrawn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
KRR
Device Class
Class II
Regulation
21 CFR Part 888.3540
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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