Panels › Orthopedic › Product code KWT · Class 2
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation 888.3650
2510(k)s in 12 months (72 all time)
0recalls in 12 months (31 all time)
28recalls that name a 510(k)
Top companies in KWT
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer | 8 | 16 |
| Biomet, Inc. | 11 | 4 |
| Exactech, Inc. | 4 | 5 |
| Catalyst Orthoscience, Inc. | 5 | 0 |
| Intermedics Orthopedics | 5 | 0 |
| Zimmer Biomet, Inc. | 0 | 5 |
| Kirschner Medical Corp. | 4 | 0 |
| Biomet Orthopedics | 3 | 0 |
| Depuy, Inc. | 3 | 0 |
| Implantcast GmbH | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Equinoxe Reverse Shoulder System, Catalog Numbers:
a) 320-36-00,
b) 320-36-03,
c) 320-36-04,
d) 320-36-10,
e) 320-36-13,
f) 320-38-00,
g) 320-38-13,
h) 320-40-00,
i) 320-40-10,
j) Open, Classified |
KWT | K063569 K093275 +2 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Custom Devices, Item Nos. 32855090246
32855090252
32855090256
32855090265
32855090266
32855090270
32855090287
32855090290
32855090291
32855090297
32855090302
32855090317
32855090318
3285509031 Terminated |
KWT | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613
00430900103
00434210613
00434210813
00434210817
00434210913
00434211013
00434211017
00434211113
00434211213
00434211217
00434211313
0043 Terminated |
KWT | K130661 |
| Oct 10, 2019 | Zimmer Biomet, Inc. BF Humeral Stem, Various Sizes, Item Nos. 00430000606
00430000613
00430000706
00430000713
00430000813
00430000817
00430000820
00430000913
00430001013
00430001017
00430001020
00430001113
00430001213
00 Terminated |
KWT | K982981 |
| Aug 21, 2018 | Exactech, Inc. Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00
Product Usage:
Shoulder surgery Open, Classified |
KWT | K063569 |
| Mar 23, 2018 | Biomet, Inc. Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction Terminated |
KWT | K111746 |
| Sep 22, 2017 | Zimmer Biomet, Inc. Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile Terminated |
KWT | K052906 |
| Jun 5, 2017 | Zimmer Biomet, Inc. COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 Terminated |
KWT | K023063 |
| Oct 25, 2016 | Exactech, Inc. Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit Terminated |
KWT | K063569 |
| Sep 2, 2015 | Limacorporate S.p.A SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445;
SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm Terminated |
KWT | K100858 |
| Feb 26, 2014 | Zimmer, Inc. 00434811113, REF I4348-111-13
Zimmer Trabecular Metal Shoulder
Humeral Stem 48 Degrees
11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Terminated |
KWT | K041549 |
| Feb 24, 2014 | Zimmer, Inc. Trabecular Metal" Reverse Shoulder System Terminated |
KWT | K052906 |
| Dec 30, 2013 | Zimmer, Inc. Trabecular Metal (TM) Reverse Glenosphere 36mm
Part 00-4349-036-11
The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheum Terminated |
KWT | K130661 |
| Aug 26, 2013 | Zimmer, Inc. 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use)
The Glenosphere Distractor must be able to attach, connect, or mate with the Glenospher Terminated |
KWT | K052906 |
| Dec 5, 2012 | Biomet, Inc. Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant)
Product Usage:
The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during th Terminated |
KWT | K030710 |
| Nov 6, 2012 | Zimmer, Inc. Zimmer Inverse/Reverse Screw system, Terminated |
KWT | None listed |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Reverse Glenosphere Locking Screw
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWT | K102951 |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Reverse Compression Screw
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWT | K063569 |
| Jun 27, 2012 | Zimmer, Inc. Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder. Terminated |
KWT | K103404 |
| Dec 9, 2010 | Zimmer Inc. Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4.
The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with s Terminated |
KWT | K041549 K050761 +2 |
| Dec 9, 2010 | Zimmer Inc. Zimmer Trabecular Metal Humeral Stem 4-Part Fracture
Surgical Technique. Catalog Number 97-4309-004-00, Rev. 3.
The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi Terminated |
KWT | K041549 K050761 +2 |
| Dec 9, 2010 | Zimmer Inc. Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, Rev. 3
The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrai Terminated |
KWT | K041549 K050761 +2 |
| Dec 9, 2010 | Zimmer Inc. TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-020-00.
The intramed Terminated |
KWT | K041549 K050761 +2 |
| Dec 9, 2010 | Zimmer Inc. BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Numbe Terminated |
KWT | None listed |
| Dec 9, 2010 | Zimmer Inc. ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00- Terminated |
KWT | K050761 K052906 +1 |
| Dec 9, 2010 | Zimmer Inc. ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4 Terminated |
KWT | K041549 K050761 +2 |
| Sep 16, 2008 | Biomet, Inc. Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to fu Terminated |
KWT | K060694 |
| Aug 26, 2006 | Zimmer Inc. Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00. Terminated |
KWT | K052906 |
| Aug 26, 2006 | Zimmer Inc. Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01. Terminated |
KWT | K052906 |
| Aug 26, 2006 | Zimmer Inc. Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01. Terminated |
KWT | K052906 |
| Jul 20, 2004 | Biomet, Inc. Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156. Terminated |
KWT | K002998 |
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