GLENOID RESURFACING COMPONENT-3M-10816— 510(k) K831233

Clearance details

Applicant

3M Company

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

1983-04-15

Decision date

1983-06-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Monrovia, CA, US

• K262173 — N22 Offset Humeral Head2026-09-08
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11

• K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE +3 more2025-01-28
• K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493 +4 more2024-11-25
• K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more2024-10-18
• K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more2024-09-12
• K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E2024-06-27

Injury

2,467

Other

2

Total

2,469

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 →