KWL · Class II · 21 CFR 888.3360

FDA Product Code KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

Leading manufacturers include Depuy, Inc., Biomet, Inc. and Howmedica Corp..

107
Total
107
Cleared
110d
Avg days
1979
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 99d avg (recent)

FDA 510(k) Cleared Prosthesis, Hip, Hemi-, Femoral, Metal Devices (Product Code KWL)

107 devices
1–24 of 107
Cleared May 15, 2026
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
K260536
Depuy Ireland UC
Orthopedic · 87d
Cleared Dec 23, 2025
OsteoRemedies Hip Spacer System
K253675
Osteoremedies, LLC
Orthopedic · 32d
Cleared Aug 06, 2025
InterSpace GV Hip Spacer
K252326
Tecres S.P.A.
Orthopedic · 12d
Cleared Jun 12, 2025
Synicem Hip Spacer
K242865
Biocomposites, Ltd.
Orthopedic · 265d
Cleared Feb 15, 2024
COPAL® exchange G hip spacer
K234028
Heraeus Medical GmbH
Orthopedic · 57d
Cleared Oct 21, 2022
UHR Bipolar Implants, Restoration GAP II Implants
K222632
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 51d
Cleared Jan 10, 2020
OsteoRemedies Hip Spacer System
K192995
Osteoremedies, LLC
Orthopedic · 77d
Cleared Aug 23, 2019
REMEDY Acetabular Cup
K191981
Osteoremedies, LLC
Orthopedic · 30d
Cleared Aug 29, 2018
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
K172906
Osteoremedies, LLC
Orthopedic · 341d
Cleared Feb 22, 2018
Remedy Acetabular Cup
K173967
Osteoremedies, LLC
Orthopedic · 55d
Cleared Sep 10, 2007
CORIN ADAPTOR SLEEVE
K071471
Howmedica Osteonics Corp.
Orthopedic · 104d
Cleared Sep 12, 2006
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Jul 17, 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jan 25, 2002
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Sep 01, 1999
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 19, 1999
THE NEW BIO-MOORE ENDO HEADS
K984028
Biomet, Inc.
Orthopedic · 68d
Cleared Nov 15, 1995
UNITRAX V40 MODULAR ADAPTOR
K954077
Howmedica Corp.
Orthopedic · 77d
Cleared Mar 31, 1993
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K926120
Depuy, Inc.
Orthopedic · 118d
Cleared Jan 18, 1991
MTS FEMORAL HIP SYSTEM
K903877
3M Company
Orthopedic · 149d
Cleared Jan 11, 1991
MODULAR UNIPOLAR SYSTEM
K902365
Howmedica Corp.
Orthopedic · 226d
Cleared Oct 11, 1990
PROFILE COLLARED HIP PROSTHESIS
K904119
Depuy, Inc.
Orthopedic · 35d
Cleared May 02, 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853
Howmedica Corp.
Orthopedic · 148d
Cleared May 16, 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482
Depuy, Inc.
Orthopedic · 60d
Cleared Sep 22, 1988
HIP FRACTURE STEM SYSTEM
K883179
Howmedica Corp.
Orthopedic · 57d

About Product Code KWL - Regulatory Context

510(k) Submission Activity

107 total 510(k) submissions under product code KWL since 1979, with 107 receiving FDA clearance (average review time: 110 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KWL Product Code

FDA review times for KWL submissions have been consistent, averaging 99 days recently vs 110 days historically.

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