RADIAL HEAD IMPLANT— 510(k) K002644

Clearance details

Applicant

Avanta Orthopaedics, Inc.

Product code

Code KWI

Device class

Class 2

Regulation

21 CFR 888.3170

Advisory panel

Orthopedic

Date received

2000-08-24

Decision date

2000-11-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

• 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

• K030881 — AVANTA CARPAL FUSION PLATING SYSTEM2003-04-10
• K021859 — WRIST IMPLANT2002-12-02
• K023604 — MODIFICATION TO RADIAL HEAD IMPLANT2002-11-27
• K013629 — FINGER JOINT PROSTHESIS2002-01-25
• K010847 — K'FIX2001-06-19

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 →

• Z-2677-2018 — rHead Stem Implant Plasma 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-2678-2018 — rHead 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-2679-2018 — rHead 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-2680-2018 — rHead 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-2681-2018 — rHead 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-2682-2018 — rHead 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-2683-2018 — rHead 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-2684-2018 — rHead 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-2685-2018 — rHead Recon Stem Implant Plasma 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-2722-2018 — radial head implant #2 (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-2723-2018 — radial head implant #3 (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-2724-2018 — radial head implant #4 (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-2725-2018 — radial stem implant #1 (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-2726-2018 — rHead, Radial Implant 6 mm 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-2727-2018 — radial stem implant #2 (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-2728-2018 — radial stem implant #2 (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-2729-2018 — radial stem implant #3 (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-2730-2018 — rHead, Radial Implant 6 mm 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-2731-2018 — radial stem implant #4 (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-2732-2018 — rHead, Radial Implant 6 mm 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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002644.