ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM— 510(k) K062861

Name: FDA 510(k) clearance K062861
Creator: U.S. Food and Drug Administration
Published: 2006-10-31

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K062861 for ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM, Substantially Equivalent on 2006-10-31. Applicant: Ascension Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 2006-09-25
Decision date: 2006-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSD

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K233260 — Univers Revers CA Head and Adapter2024-02-12
K221232 — Univers Revers Humeral Cup Implant2022-05-19
K191433 — AGILON® XO Shoulder Replacement System2020-11-12
K193122 — Biocore9 Humeral Resurfacing System2020-05-15
K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18

More clearances from Ascension Orthopedics, Inc.

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K233674 — Freedom Wrist Arthroplasty System2024-05-30
K233670 — Ascension Silicone MCP; Ascension Silicone PIP2023-12-14
K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM2013-02-13
K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM2011-12-06
K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY2010-12-21

Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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 K062861

K-number listed on FDA's recall record

Z-0794-2019 — Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WWClass III·Terminated·Ascension Orthopedics, Inc·20181116

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062861.

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