Product code KWZ— Orthopedic
PINNACLE CONSTRAINED ACETABULAR LINERS
- Classification name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Total cleared
- 34
- First cleared
- Most recent
Market context for product code KWZ
FDA has cleared devices under product code KWZ between 1981 and 2025, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2017
- 2016
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code KWZ
Adverse events under product code KWZ
product code KWZ- Injury
- 993
- Total
- 993
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KWZ
- K241461 — Mpact Constrained Liner
- K240639 — PINNACLETM Constrained Acetabular Liners
- K162641 — Smith & Nephew, Inc. R3 Constrained Liner
- 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 Bolt
- K161610 — EXPRT Revision Hip System
- K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERS
- K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERS
- K101730 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
- K083566 — R3 CONSTRAINED LINER, CONSTRAINED LINER
- K072121 — TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER
- K071059 — DEPUY SPA POROUS COATED PROXIMAL SLEEVE
- K071676 — EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
- K071718 — TRILOGY LONGEVITY CONSTRAINED LINER
- K071117 — MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
- K063445 — PCA CONSTRAINED ACETABULAR LINERS
- K063550 — SYSTEM 12 CONSTRAINED ACETABULAR LINERS
- K063552 — SERIES II CONSTRAINED ACETABULAR LINERS
- K061654 — TRIDENT CONSTRAINED ACETABULAR INSERT
- K052079 — PINNACLE CONSTRAINED ACETABULAR LINERS
- K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS
- K040601 — EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
- K040225 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
- K033442 — REFLECTION CONSTRAINED LINER
- K030923 — EPSILON DURASUL CONSTRAINED ACETABULAR LINER
- K023794 — CONSTRAINED LINER
- K030047 — FREEDOM CONSTRAINED LINERS
- K021826 — TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
- K021803 — REFLECTION CONSTRAINED LINER
- K021661 — RINGLOC CONSTRAINED LINERS
- K021728 — RINGLOC CONSTRAINED LINERS II
- K950202 — RINGLOC CONSTRAINED LINER
- K890197 — OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT
- K870271 — S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP
- K803192 — HCL ACETABULAR COMPONENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.