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)
Top companies in KWS
| Company | 510(k)s | Recalls |
|---|---|---|
| Encore Medical L.P. | 9 | 35 |
| Exactech, Inc. | 8 | 23 |
| Tornier | 24 | 6 |
| Zimmer GmbH | 7 | 20 |
| Biomet, Inc. | 4 | 21 |
| DePuy Orthopaedics, Inc. | 9 | 11 |
| Tournier, Inc. | 0 | 18 |
| Smith & Nephew, Inc. | 11 | 6 |
| Arthrex, Inc. | 15 | 0 |
| Lima Corporate S.P.A. | 8 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica 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 |
KWS | K962082 |
| Apr 3, 2026 | Tornier, 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 |
KWS | K251686 |
| Feb 24, 2026 | Encore 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 |
KWS | K100741 |
| Feb 2, 2026 | Tornier, Inc TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 Open, Classified |
KWS | K161742 |
| Sep 10, 2025 | Encore 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 |
KWS | K233481 |
| Sep 10, 2025 | Encore 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 |
KWS | K233481 |
| Sep 10, 2025 | Encore 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 |
KWS | K233481 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K113309 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K113309 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K113309 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K113309 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K121220 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K121220 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K111379 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K111379 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K103419 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K103419 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K042021 K093430 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K042021 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K042021 |
| Mar 29, 2024 | Exactech, 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 |
KWS | K042021 |
| Jan 18, 2024 | Exactech, 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 |
KWS | K212356 |
| Nov 8, 2023 | Encore 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 |
KWS | K172351 |
| Sep 19, 2023 | Encore Medical, LP DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell,
Size 6 x 108mm, REF: 533-06-108 Open, Classified |
KWS | K172351 |
| Jun 28, 2023 | Tornier, Inc AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 Open, Classified |
KWS | K191318 |
| Jun 28, 2023 | Tornier, Inc AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 Open, Classified |
KWS | K191318 |
| Jun 28, 2021 | Encore 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 |
KWS | K162024 |
| May 28, 2021 | Tornier, Inc Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile
Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. Terminated |
KWS | K122698 |
| Dec 17, 2020 | Biomet, Inc. Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting. Terminated |
KWS | None listed |
| Dec 17, 2020 | Biomet, 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 |
KWS | K130390 K132239 +1 |
| Oct 6, 2020 | Exactech, Inc. Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium Terminated |
KWS | K113309 |
| Oct 6, 2020 | Exactech, Inc. Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium Terminated |
KWS | K113309 |
| Aug 31, 2020 | Encore 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 |
KWS | K172351 |
| Jul 17, 2020 | Materialise 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 |
KWS | K153602 K170893 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414. Terminated |
KWS | K131135 K160071 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412. Terminated |
KWS | K131135 K160071 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410. Terminated |
KWS | K131135 K160071 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408. Terminated |
KWS | K131135 K160071 |
| Apr 3, 2020 | Biomet, Inc. BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406. Terminated |
KWS | K131135 K160071 |
| Nov 4, 2019 | Medacta 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 |
KWS | K170910 |
| Aug 21, 2019 | Zimmer 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 |
KWS | K172502 |
| Dec 21, 2018 | Zimmer 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 |
KWS | K120121 |
| Feb 27, 2018 | DePuy 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 |
KWS | K133834 |
| Jan 29, 2018 | Encore 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 |
KWS | K162024 |
| Jan 29, 2018 | Encore 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 |
KWS | K162024 |
| Jan 29, 2018 | Encore 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 |
KWS | K162024 |
| Jan 29, 2018 | Encore 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 |
KWS | K162024 |
| Jan 29, 2018 | Encore 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 |
KWS | K162024 |
| Jan 18, 2018 | Exactech, 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 |
KWS | K113309 |
| Jan 18, 2018 | Exactech, 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 |
KWS | K113309 |
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