LZO · Class II · 21 CFR 888.3353

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 Medacta International S.A., Smith & Nephew, Inc. and Zimmer, Inc..

534
Total
534
Cleared
144d
Avg days
1985
Since
Growing category - 24 submissions in the last 2 years vs 19 in the prior period
Consistent review times: 143d avg (recent)

FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented Devices (Product Code LZO)

534 devices
1–24 of 534
Cleared Oct 01, 2026
NEXUS® Hip Stem
K262473
Microport Orthopedics, Inc.
Orthopedic · 76d
Cleared Sep 17, 2026
M-Vizion Femoral Revision System Extension
K260173
Medacta International S.A.
Orthopedic · 239d
Cleared Sep 02, 2026
Momentum Acetabular Cup System
K253948
United Orthopedic Corporation
Orthopedic · 266d
Cleared Jul 06, 2026
MobileLink Acetabular Cup System – 40mm ID Inserts (various)
K261009
Waldemar Link GmbH & Co. KG
Orthopedic · 102d
Cleared Jun 16, 2026
Z1 Hip System
K260831
Zimmer, Inc.
Orthopedic · 95d
Cleared Apr 27, 2026
Avenir® Müller Stem
K260182
Zimmer, Inc.
Orthopedic · 96d
Cleared Mar 12, 2026
implaFit® short stems
K252401
Implantcast GmbH
Orthopedic · 224d
Cleared Jan 15, 2026
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
K253171
Maxx Orthopedics, Inc.
Orthopedic · 111d
Cleared Sep 19, 2025
Coated hip implants
K250450
Medacta International S.A.
Orthopedic · 213d
Cleared Aug 07, 2025
Longboard Revision Hip Stem
K243021
Signature Orthopaedics Pty, Ltd.
Orthopedic · 314d
Cleared Jul 18, 2025
Z1 Hip System
K251906
Zimmer, Inc.
Orthopedic · 28d
Cleared May 23, 2025
RECLAIM Monobloc Revision Femoral Stem
K251292
Depuy Ireland UC
Orthopedic · 28d
Cleared May 16, 2025
MobileLink Acetabular Cup System - inhouse coatings
K243927
Waldemar Link GmbH & Co. KG
Orthopedic · 147d
Cleared May 15, 2025
NEXUS® Hip Stem
K250444
Microport Orthopedics, Inc.
Orthopedic · 90d
Cleared May 02, 2025
Origin™ Cemented Hip Stem
K243043
Signature Orthopaedics Pty, Ltd.
Orthopedic · 217d
Cleared Apr 18, 2025
Zimmer Biomet Ceramic Heads (22.2mm diameter)
K250834
Zimmer Biomet
Orthopedic · 30d
Cleared Mar 28, 2025
CATALYSTEM Femoral Stems
K250571
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 11, 2025
Origin™ TT Stem
K243029
Signature Orthopaedics Pty, Ltd.
Orthopedic · 165d
Cleared Mar 06, 2025
Versacem Acetabular Shell and Double Mobility HC Liners
K241767
Medacta International S.A.
Orthopedic · 259d
Cleared Mar 04, 2025
Biolox® Delta Revision heads
K243809
Limacorporate
Orthopedic · 83d
Cleared Feb 07, 2025
ceramys™ femoral head system
K241483
Encore Medical, L.P.
Orthopedic · 259d
Cleared Jan 06, 2025
Conformity Stem Extension Line, #0
K243466
United Orthopedic Corporation
Orthopedic · 59d
Cleared Dec 05, 2024
BIOCERAM AZUL® HEAD
K243444
Kyocera Corporation
Orthopedic · 29d
Cleared Nov 15, 2024
b-ONE® Total Hip System
K240528
B-One Ortho, Corp.
Orthopedic · 266d

About Product Code LZO - Regulatory Context

510(k) Submission Activity

534 total 510(k) submissions under product code LZO since 1985, with 534 receiving FDA clearance (average review time: 144 days).

Submission volume has increased in recent years - 24 submissions in the last 24 months compared to 19 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LZO Product Code

FDA review times for LZO submissions have been consistent, averaging 143 days recently vs 145 days historically.

LZO devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →