Atlas FDA

GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD

FDA 510(k) clearance K984541 · decided 1999-01-14

Clearance details

K-number
K984541
Device name
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
1998-12-21
Decision date
1999-01-14
Days to decision
24 days
Clearance type
Special
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch DePuy Orthopaedics

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713)Exactech, Inc.2025-12-01
Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686)Tornier, Inc.2025-10-30
AGILON® XO Shoulder Replacement System (K241944)Implantcast GmbH2025-03-10
InSet Total Shoulder System (K241817)Shoulder Innovations, Inc.2025-02-11
AGILON® XO Shoulder Replacement System (K231657)Implantcast GmbH2024-02-16
Comprehensive Segmental Revision System(SRS) (K223631)Biomet Orthopedics2023-07-12
AGILON XO Shoulder System (K222482)Implantcast GmbH2022-09-28
LINK Embrace Shoulder System- Anatomical Configuration (K210899)Waldemar Link GmbH & Co. KG2021-06-21
TiN Coated Humeral Head (K191698)Fx Shoulder USA, Inc.2020-07-16
Shoulder Innovations Total Shoulder System (K192365)Shoulder Innovations, Inc.2019-11-29
Catalyst OrthoScience CSR Shoulder System (K191811)Catalyst Orthoscience, Inc.2019-09-11
Signature ONE System (K190595)Orthosoft Inc (D/B/A Zimmer Cas)2019-06-05

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CERAMAX® Ceramic Total Hip System (P070026/S128)DePuy Orthopaedics, Inc.2026-07-24
CERAMAX CERAMIC HIP SYSTEM (P070026/S127)DePuy Orthopaedics, Inc.2026-06-03
Ceramax® Ceramic Hip System (P070026/S125)DePuy Orthopaedics, Inc.2026-04-29
Ceramax Ceramic Hip System (P070026/S124)DePuy Orthopaedics, Inc.2026-04-10
Ceramax® Ceramic Total Hip System (P070026/S118)DePuy Orthopaedics, Inc.2026-01-08
Ceramax Ceramic Hip System (P070026/S123)DePuy Orthopaedics, Inc.2025-12-09
CERAMAX CERAMIC HIP SYSTEM (P070026/S121)DePuy Orthopaedics, Inc.2025-08-05
CERAMAX CERAMIC HIP SYSTEM (P070026/S122)DePuy Orthopaedics, Inc.2025-08-01