HSD · Class II · 21 CFR 888.3690

FDA Product Code HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Leading manufacturers include Howmedica Osteonics Corp., Arthrex, Inc. and DePuy Orthopaedics, Inc..

71
Total
71
Cleared
120d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Devices (Product Code HSD)

71 devices
1–24 of 71
Cleared Feb 12, 2024
Univers Revers CA Head and Adapter
K233260
Arthrex, Inc.
Orthopedic · 136d
Cleared May 19, 2022
Univers Revers Humeral Cup Implant
K221232
Arthrex, Inc.
Orthopedic · 20d
Cleared Nov 12, 2020
AGILON® XO Shoulder Replacement System
K191433
Implantcast GmbH
Orthopedic · 533d
Cleared May 15, 2020
Biocore9 Humeral Resurfacing System
K193122
Biocore9, LLC
Orthopedic · 185d
Cleared Apr 18, 2018
OVOMotion Shoulder Arthroplasty System
K173964
Arthrosurface, Inc.
Orthopedic · 110d
Cleared Nov 21, 2016
Arthrex Univers Revers Shoulder Prosthesis System
K161782
Arthrex, Inc.
Orthopedic · 145d
Cleared Nov 01, 2016
Anatomical Shoulder Domelock Dome centric
K161620
Zimmer GmbH
Orthopedic · 141d
Cleared Apr 19, 2016
Arthrex Univers Revers CA Heads and Adapters
K151527
Arthrex, Inc.
Orthopedic · 316d
Cleared Dec 19, 2014
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
K142942
Arthrosurface, Inc.
Orthopedic · 66d
Cleared Nov 26, 2013
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298
Exactech, Inc.
Orthopedic · 204d
Cleared Nov 09, 2013
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
K130759
Fx Solutions
Orthopedic · 234d
Cleared Oct 30, 2013
ARTHREX UNIVERS II CA HEADS
K130675
Arthrex, Inc.
Orthopedic · 231d
Cleared Aug 26, 2013
SEVIIN SURFACE REPLACEMENT SHOULDER
K130635
Ingen Orthopedics, LLC
Orthopedic · 168d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Jun 01, 2012
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
K112900
Lima Corporate S.P.A.
Orthopedic · 242d
Cleared Dec 12, 2011
SPACER-S
K112983
Tecres S.P.A.
Orthopedic · 67d
Cleared Nov 09, 2011
HUMELOCK CEMENTED SHOULDER PROSTHESIS
K111097
Fx Solutions
Orthopedic · 203d
Cleared Dec 18, 2008
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715
DePuy Orthopaedics, Inc.
Orthopedic · 92d
Cleared Aug 08, 2008
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990
DePuy Orthopaedics, Inc.
Orthopedic · 123d
Cleared Nov 28, 2007
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
K072578
Synthes (Usa)
Orthopedic · 76d
Cleared Jun 22, 2007
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
K071064
Ascension Orthopedics, Inc.
Orthopedic · 67d
Cleared May 04, 2007
REUNION HA FRACTURE STEM
K070963
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Dec 22, 2006
AEQUALIS RESURFACING HEAD
K062661
Tornier
Orthopedic · 106d
Cleared Dec 13, 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845
Howmedica Osteonics Corp.
Orthopedic · 82d

About Product Code HSD - Regulatory Context

510(k) Submission Activity

71 total 510(k) submissions under product code HSD since 1979, with 71 receiving FDA clearance (average review time: 120 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.