Restoration® Modular Hip System

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Howmedica Osteonics Corp. (aka Stryker Orthopaedics)

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. (aka Stryker Orthopaedics) with the FDA for Restoration® Modular Hip System.

Pre-market Notification Details

• Device ID: K193233
• 510k Number: K193233
• Device Name: Restoration® Modular Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Howmedica Osteonics Corp. (aka Stryker Orthopaedics) 325 Corporate Drive Mahwah, NJ 07430
• Contact: Nora O'connor
• Correspondent: Nora O'connor; Howmedica Osteonics Corp. (aka Stryker Orthopaedics) 325 Corporate Drive Mahwah, NJ 07430
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• Subsequent Product Code: MAY
• Subsequent Product Code: MBL
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-25
• Decision Date: 2020-05-27