KWL · Class II · 21 CFR 888.3360

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

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

108
Total
108
Cleared
109d
Avg days
1979
Since
Growing category - 5 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 83d recently vs 110d historically

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

108 devices
1–24 of 108
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 Mar 17, 2015
Evolve UniPolar Head
K143184
Signature Orthopaedics Pty, Ltd.
Orthopedic · 132d
Cleared Aug 04, 2011
CORIN OPTIMOM MODULAR HEAD
K111911
Corin USA
Orthopedic · 30d
Cleared Sep 10, 2007
CORIN ADAPTOR SLEEVE
K071471
Howmedica Osteonics Corp.
Orthopedic · 104d
Cleared Apr 03, 2007
CORIN UNIPOLAR MODULAR HEAD
K063791
Corin USA
Orthopedic · 102d
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 27, 2005
SOLITUDE UNIPOLAR HEAD
K042973
Ortho Development Corp.
Orthopedic · 91d
Cleared Jan 22, 2004
SPACER G TEMPORARY HIP PROSTHESIS
K031841
Exactech, Inc.
Orthopedic · 220d
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 Mar 15, 1999
PLUS FRACTURE HEAD PROSTHESIS
K990309
Plus Orthopedics
Orthopedic · 42d
Cleared Feb 24, 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585
Osteonics Corp.
Orthopedic · 62d
Cleared Jan 19, 1999
THE NEW BIO-MOORE ENDO HEADS
K984028
Biomet, Inc.
Orthopedic · 68d
Cleared Aug 21, 1998
ARGOMEDICAL BIPOLAR SYSTEM
K981451
Stelkast Company
Orthopedic · 121d

About Product Code KWL - Regulatory Context

510(k) Submission Activity

108 total 510(k) submissions under product code KWL since 1979, with 108 receiving FDA clearance (average review time: 109 days).

Submission volume has increased in recent years - 5 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

Recent submissions under KWL have taken an average of 83 days to reach a decision - down from 110 days historically, suggesting improved FDA processing for this classification.

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