RADIAL HEAD IMPLANT— 510(k) K982288

Name: FDA 510(k) clearance K982288
Creator: U.S. Food and Drug Administration
Published: 1998-09-08

Substantially Equivalent

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K982288 for RADIAL HEAD IMPLANT, Substantially Equivalent on 1998-09-08. 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: 1998-06-30
Decision date: 1998-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
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
K023604 — MODIFICATION TO RADIAL HEAD IMPLANT2002-11-27
K013629 — FINGER JOINT PROSTHESIS2002-01-25
K010847 — K'FIX2001-06-19

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 K982288

K-number listed on FDA's recall record

Z-0098-2014 — Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.Class II·Terminated·Small Bone Innovations, Inc.·20130906

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982288.

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