FDA Product Code LZO: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Hip replacement surgery restores mobility and eliminates pain in patients with advanced joint disease. FDA product code LZO covers semi-constrained hip prostheses with metal, ceramic, or polymer bearing surfaces.
These implants replace the femoral head and acetabular socket with engineered bearing couples designed to minimize wear and maximize longevity. Material combinations include metal-on-polyethylene, ceramic-on-ceramic, and ceramic-on-polyethylene.
LZO devices are Class II medical devices, regulated under 21 CFR 888.3353 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Medacta International S.A. and Howmedica Osteonics Corp..
529
Total
529
Cleared
144d
Avg days
1985
Since
Stable submission activity - 22 submissions in the last 2 years
Consistent review times:
139d avg (recent)
FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented Devices (Product Code LZO)
529 devices
Cleared
Apr 27, 2026
Avenir® Müller Stem
Zimmer, Inc.
Orthopedic
96d
Cleared
Mar 12, 2026
implaFit® short stems
Implantcast GmbH
Orthopedic
224d
Cleared
Jan 15, 2026
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
Maxx Orthopedics, Inc.
Orthopedic
111d
Cleared
Sep 19, 2025
Coated hip implants
Medacta International S.A.
Orthopedic
213d
Cleared
Aug 07, 2025
Longboard Revision Hip Stem
Signature Orthopaedics Pty, Ltd.
Orthopedic
314d
Cleared
Jul 18, 2025
Z1 Hip System
Zimmer, Inc.
Orthopedic
28d
Cleared
May 23, 2025
RECLAIM Monobloc Revision Femoral Stem
Depuy Ireland UC
Orthopedic
28d
Cleared
May 16, 2025
MobileLink Acetabular Cup System - inhouse coatings
Waldemar Link GmbH & Co. KG
Orthopedic
147d
Cleared
May 15, 2025
NEXUS® Hip Stem
Microport Orthopedics, Inc.
Orthopedic
90d
Cleared
May 02, 2025
Origin™ Cemented Hip Stem
Signature Orthopaedics Pty, Ltd.
Orthopedic
217d
Cleared
Apr 18, 2025
Zimmer Biomet Ceramic Heads (22.2mm diameter)
Zimmer Biomet
Orthopedic
30d
Cleared
Mar 28, 2025
CATALYSTEM Femoral Stems
Smith & Nephew, Inc.
Orthopedic
30d
Cleared
Mar 11, 2025
Origin™ TT Stem
Signature Orthopaedics Pty, Ltd.
Orthopedic
165d
Cleared
Mar 06, 2025
Versacem Acetabular Shell and Double Mobility HC Liners
Medacta International S.A.
Orthopedic
259d
Cleared
Mar 04, 2025
Biolox® Delta Revision heads
Limacorporate
Orthopedic
83d
Cleared
Feb 07, 2025
ceramys™ femoral head system
Encore Medical, L.P.
Orthopedic
259d
Cleared
Jan 06, 2025
Conformity Stem Extension Line, #0
United Orthopedic Corporation
Orthopedic
59d
Cleared
Dec 05, 2024
BIOCERAM AZUL® HEAD
Kyocera Corporation
Orthopedic
29d
Cleared
Nov 15, 2024
b-ONE® Total Hip System
B-One Ortho, Corp.
Orthopedic
266d
Cleared
Oct 24, 2024
MUTARS® femoral stem cemented 160 mm and 200 mm
Implantcast GmbH
Orthopedic
259d
Cleared
Aug 30, 2024
Conformity Stem Extension Line
United Orthopedic Corporation
Orthopedic
30d
Cleared
Aug 27, 2024
Z1 Cemented Hip System
Orchard Medical Development, LLC
Orthopedic
116d
Cleared
Jun 27, 2024
CATALYSTEM Femoral Stems
Smith & Nephew, Inc.
Orthopedic
140d
Cleared
Jun 03, 2024
EcoFit® short stem cementless cpTi
Implantcast GmbH
Orthopedic
69d
About Product Code LZO - Regulatory Context
510(k) Submission Activity
529 total 510(k) submissions under product code LZO since 1985, with 529 receiving FDA clearance (average review time: 144 days).
Submission volume has remained relatively stable over the observed period, with 22 submissions in the last 24 months.
FDA 510(k) Review Time - LZO Product Code
FDA review times for LZO submissions have been consistent, averaging 139 days recently vs 145 days historically.
LZO devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →