MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS— 510(k) K071117

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code KWZ

Device class

Class 2

Regulation

21 CFR 888.3310

Advisory panel

Orthopedic

Date received

2007-04-20

Decision date

2007-05-18

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

• K241461 — Mpact Constrained Liner2025-07-31
• K240639 — PINNACLETM Constrained Acetabular Liners2024-04-04
• K162641 — Smith & Nephew, Inc. R3 Constrained Liner2017-06-19
• K163497 — EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt2017-03-02
• K161610 — EXPRT Revision Hip System2016-11-09

• K252887 — DePuy ATTUNE Knee System2026-05-22
• K231503 — CUPTIMIZE Advanced2023-08-22
• K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
• K210167 — DELTA XTEND Reverse Shoulder System2021-02-19
• K203167 — DePuy Corail AMT Hip Prosthesis2020-11-19

Injury

993

Total

993

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2414-2012 — S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom¿ stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.Class II·Terminated·DePuy Orthopaedics, Inc.·20120822

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071117.