DEPUY PINNACLE ALTRX ACETABULAR LINERS— 510(k) K102423

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2010-08-25

Decision date

2010-10-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

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• K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
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• K251270 — Taperloc® Complete Hip Stem2026-05-19

• 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

Death

73

Injury

31,640

Malfunction

3,358

Other

2

Total

35,073

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-2220-2012 — Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants 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.·20120724
• Z-1366-2013 — Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants 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.·20120307

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102423.