ClearanceBrief
Panels › Orthopedic › Product code KWS · Class 2

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Regulation 888.3660

3510(k)s in 12 months (191 all time)
4recalls in 12 months (153 all time)
131recalls that name a 510(k)
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Top companies in KWS

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Howmedica Osteonics Corp.
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #
Open, Classified
KWSK962082
Apr 3, 2026Tornier, Inc
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat.
Open, Classified
KWSK251686
Feb 24, 2026Encore Medical, LP
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Open, Classified
KWSK100741
Feb 2, 2026Tornier, Inc
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Open, Classified
KWSK161742
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
Open, Classified
KWSK233481
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
Open, Classified
KWSK233481
Sep 10, 2025Encore Medical, LP
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
Open, Classified
KWSK233481
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44,
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 4
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Larg
Open, Classified
KWSK113309
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Numbe
Open, Classified
KWSK121220
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number
Open, Classified
KWSK121220
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Numbe
Open, Classified
KWSK111379
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number
Open, Classified
KWSK111379
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33,
Open, Classified
KWSK103419
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c
Open, Classified
KWSK103419
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large,
Open, Classified
KWSK042021
K093430
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shou
Open, Classified
KWSK042021
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shou
Open, Classified
KWSK042021
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Sh
Open, Classified
KWSK042021
Jan 18, 2024Exactech, Inc.
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-3
Open, Classified
KWSK212356
Nov 8, 2023Encore Medical, LP
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Open, Classified
KWSK172351
Sep 19, 2023Encore Medical, LP
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
Open, Classified
KWSK172351
Jun 28, 2023Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Open, Classified
KWSK191318
Jun 28, 2023Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Open, Classified
KWSK191318
Jun 28, 2021Encore Medical, LP
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Open, Classified
KWSK162024
May 28, 2021Tornier, Inc
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Terminated
KWSK122698
Dec 17, 2020Biomet, Inc.
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
Terminated
KWSNone listed
Dec 17, 2020Biomet, Inc.
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: in
Terminated
KWSK130390
K132239 +1
Oct 6, 2020Exactech, Inc.
Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
Terminated
KWSK113309
Oct 6, 2020Exactech, Inc.
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Terminated
KWSK113309
Aug 31, 2020Encore Medical, LP
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are can
Terminated
KWSK172351
Jul 17, 2020Materialise N.V.
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthro
Terminated
KWSK153602
K170893
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Terminated
KWSK131135
K160071
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Terminated
KWSK131135
K160071
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Terminated
KWSK131135
K160071
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Terminated
KWSK131135
K160071
Apr 3, 2020Biomet, Inc.
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Terminated
KWSK131135
K160071
Nov 4, 2019Medacta Usa Inc
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral frac
Terminated
KWSK170910
Aug 21, 2019Zimmer Biomet, Inc.
COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555
Terminated
KWSK172502
Dec 21, 2018Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose sho
Terminated
KWSK120121
Feb 27, 2018DePuy Orthopaedics, Inc.
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-0
Terminated
KWSK133834
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoul
Completed
KWSK162024
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed
KWSK162024
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed
KWSK162024
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed
KWSK162024
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed
KWSK162024
Jan 18, 2018Exactech, Inc.
Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joi
Terminated
KWSK113309
Jan 18, 2018Exactech, Inc.
Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral join
Terminated
KWSK113309

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