RHEAD RADIAL HEAD EXTENDED STEMS— 510(k) K102180

Name: FDA 510(k) clearance K102180
Creator: U.S. Food and Drug Administration
Published: 2010-12-20

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K102180 for RHEAD RADIAL HEAD EXTENDED STEMS, Substantially Equivalent on 2010-12-20. Applicant: Small Bone Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code JDB
Device class: Class 2
Regulation: 21 CFR 888.3160
Advisory panel: Orthopedic
Date received: 2010-08-02
Decision date: 2010-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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 K102180

K-number listed on FDA's recall record

Z-2703-2018 — rHead Standard Extended Stem, 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-2704-2018 — rHead Standard Extended Stem, 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-2705-2018 — rHead Standard Extended Stem, 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-2706-2018 — rHead Standard Extended Stem, 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-2707-2018 — rHead Recon Extended Stem 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-2708-2018 — rHead Recon Extended Stem 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-2709-2018 — rHead Recon Extended Stem 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-2426-2015 — rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20150624
Z-2429-2015 — Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20150624

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102180.

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