26 MM Cast Cocr Head and Polyethylene Acetabular Shell Liner

Q: What is the product code of K991622?

The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.

FDA 510(k) K991622 · Stelkast Company

Substantially Equivalent

510(k) numberK991622

Submission

Device name: 26 MM Cast Cocr Head and Polyethylene Acetabular Shell Liner
Applicant: Stelkast Company
Pittsburgh, PA, US
Received: May 11, 1999
Decision date: July 14, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3350
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code JDI

510(k)	Device	Applicant	Decision
K253515	Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional	Biomet Orthopedics, Inc.	08/24/2026SE
K253434	OSSTM Orthopedic Salvage SystemJDI · Traditional	Biomet, Inc.	07/01/2026SE
K252824	Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional	Signature Orthopaedics Pty, Ltd.	03/12/2026SE
K243571	Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional	Zimmer Biomet	07/31/2025SE
K240783	Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional	Smith & Nephew, Inc.	10/21/2024SE
K241716	Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional	Howmedica Osteonics Corp., Dba Stryker…	08/02/2024SE
K240418	Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional	Howmedica Osteonics Corp., Dba Stryker…	04/12/2024SE
K233261	Global Modular Replacement SystemJDI · Traditional	Howmedica Osteonics Corp. A.K.A. Stryker…	12/08/2023SE
K222056	Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional	Howmedica Osteonics Corp., Dba Stryker…	01/26/2023SE
K220216	C-Stem AMT LE ProsthesisJDI · Traditional	Depuy Ireland UC	07/22/2022SE

More from Depuy Ireland UC

510(k)	Device	Decision
K190276	Provident II Hip StemLPH · Special	03/08/2019SE
K173875	GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertJWH · Special	01/19/2018SE
K162222	GENflex2 Total Knee SystemJWH · Special	09/07/2016SE
K122883	Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemJWH · Traditional	08/05/2013SE
K122773	Cross-Over Acetabular Shell & LinerOQG · Special	10/09/2012SE
K094035	Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMOQG · Traditional	03/24/2011SE
K081458	Proven Stem ExtenderJWH · Special	06/06/2008SE
K063211	Proven Knee System High Flexion Tibial InsertJWH · Traditional	01/18/2007SE
K051976	Proven Revision Modular Tibial TrayJWH · Traditional	10/17/2005SE
K033944	Stelkast 32MM Modular Ceramic Femoral HeadLZO · Traditional	03/12/2004SE

Questions and answers

When was 26 MM Cast Cocr Head and Polyethylene Acetabular Shell Liner cleared by the FDA?

26 MM Cast Cocr Head and Polyethylene Acetabular Shell Liner (K991622) received a 510(k) decision of Substantially Equivalent on July 14, 1999, 64 days after the submission was received.

What is the product code of K991622?

The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.