MODIFICATION TO RADIAL HEAD IMPLANT— 510(k) K023604

Name: FDA 510(k) clearance K023604
Creator: U.S. Food and Drug Administration
Published: 2002-11-27

Substantially Equivalent

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K023604 for MODIFICATION TO RADIAL HEAD IMPLANT, Substantially Equivalent on 2002-11-27. Applicant: Avanta Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Avanta Orthopaedics, Inc.
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2002-10-28
Decision date: 2002-11-27
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWI

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K260624 — Arthrex Radial Head Replacement System2026-07-30
K233592 — BioPoly Radial Head Implant2024-03-13
K231188 — ALIGN Radial Head System2023-09-28
K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
K212872 — Avenger Radial Head System2021-12-17

More clearances from Avanta Orthopaedics, Inc.

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K030881 — AVANTA CARPAL FUSION PLATING SYSTEM2003-04-10
K021859 — WRIST IMPLANT2002-12-02
K013629 — FINGER JOINT PROSTHESIS2002-01-25
K010847 — K'FIX2001-06-19
K011819 — RADIAL HEAD IMPLANT2001-06-19

Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K023604

K-number listed on FDA's recall record

Z-2686-2018 — rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2687-2018 — rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2688-2018 — rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2689-2018 — rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2690-2018 — rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2691-2018 — rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2692-2018 — rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2711-2018 — #2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2712-2018 — #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2713-2018 — #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2714-2018 — #1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2715-2018 — rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2716-2018 — #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2717-2018 — rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2718-2018 — #3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2719-2018 — rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2720-2018 — #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
Z-2721-2018 — rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023604.

Data sourced from openFDA. This site is unofficial and independent of the FDA.