SC Total Hip System

Q: What is the product code of K031474?

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) K031474 · Orthopedic Alliance, LLC

Substantially Equivalent

510(k) numberK031474

Submission

Device name: SC Total Hip System
Applicant: Orthopedic Alliance, LLC
Murrieta, CA, US
Received: May 9, 2003
Decision date: October 15, 2003
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

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K253434	OSSTM Orthopedic Salvage SystemJDI · Traditional	Biomet, Inc.	07/01/2026SE
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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
K052237	SC Ceramic Ball HeadsLZO · Special	09/06/2005SE
K033826	Orthopedic Alliance Spine SystemMNI · Traditional	07/01/2004SE

Questions and answers

When was SC Total Hip System cleared by the FDA?

SC Total Hip System (K031474) received a 510(k) decision of Substantially Equivalent on October 15, 2003, 159 days after the submission was received.

What is the product code of K031474?

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.