Atlas FDA

GRISTINA GLENOID PROSTHESIS

FDA 510(k) clearance K802124 · decided 1980-12-01

Clearance details

K-number
K802124
Device name
GRISTINA GLENOID PROSTHESIS
Applicant
Howmedica Corp.
Decision
Substantially Equivalent
Date received
1980-09-04
Decision date
1980-12-01
Days to decision
88 days
Clearance type
Traditional
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Howmedica Corp.

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
SURGICAL SIMPLEX P BONE CEMENT (N17004/S013)Howmedica Corp.2000-12-15
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012)Howmedica Corp.2000-06-20
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011)Howmedica Corp.1998-03-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010)Howmedica Corp.1997-11-13
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009)Howmedica Corp.1997-08-08
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008)Howmedica Corp.1996-12-18
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005)Howmedica Corp.1995-11-21
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006)Howmedica Corp.1995-02-24