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) |
|---|---|---|---|
| Aug 31, 2017 | DePuy Orthopaedics, Inc. DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotato Terminated |
KWS | K120174 |
| Apr 26, 2017 | Zimmer Biomet, Inc. Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then pl Terminated |
KWS | K060694 |
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Extremities, Shoulders and Elbows
BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System
Product Usage:
Shoulder Replacement E Terminated |
KWS | K060694 K080642 +1 |
| Sep 19, 2016 | Tornier, Inc Aequalis Fx2 implant parts and instrument trays.
Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B Terminated |
KWS | K141345 K152966 |
| May 17, 2016 | Zimmer Gmbh Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0.
The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retro Terminated |
KWS | K142403 |
| Apr 8, 2016 | Limacorporate S.p.A SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement. Terminated |
KWS | K110598 |
| Aug 10, 2015 | Stryker Howmedica Osteonics Corp. ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument.
Howmedica Osteonics Corp.
A Subsidiary of Stryker Corp.
Stry Terminated |
KWS | K103835 |
| Apr 20, 2015 | Exactech, Inc. Equinoxe 44mm Short Humeral Head
Catalog Number 310-01-44.
Orthopedic shoulder implant component. Terminated |
KWS | K042021 |
| Feb 24, 2015 | Biomet, Inc. Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor,
Part Number: 010000589
Lot: 527400 Terminated |
KWS | K120121 |
| Nov 8, 2014 | Integra LifeSciences Corp. Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees.
The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Terminated |
KWS | K100448 |
| Jan 9, 2013 | Biomet, Inc. PT113950 PT HYBRID Glenoid Post
Regenerex porous titanium construct
Sterile R
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Terminated |
KWS | K060694 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Fracture Humeral Head Terminated |
KWS | K062029 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Ball taper for humeral stem Terminated |
KWS | K030259 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert
Sterile, Rx Terminated |
KWS | K053274 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Inverse/Reverse Glenoid
Sterile, Rx Terminated |
KWS | K053274 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Inverse Humeral Cup Terminated |
KWS | K053274 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and
Anatomical Shoulder Fracture Humeral stem Terminated |
KWS | K030259 K062029 |
| Nov 6, 2012 | Zimmer, Inc. zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340
PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345,
Glenoid M, cemented, sterile; REF 01.04214.370,
Glenoid L, cement Terminated |
KWS | K051623 K990136 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Humeral Head Terminated |
KWS | K003801 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Fracture Humeral stem Terminated |
KWS | K062029 |
| Nov 6, 2012 | Zimmer, Inc. Anatomical Shoulder" Humeral stem Terminated |
KWS | K030259 |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Reverse Shoulder Fracture Adapter Tray Screw
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWS | K073688 |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Fixed Angle Replicator Plate
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWS | K102951 |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Anatomic Replicator Plate
Intended for Primary and Reverse Total Shoulder Arthroplasty Terminated |
KWS | K042021 |
| Jul 6, 2011 | Encore Medical, Lp Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008.
The Reverse Shoulder Prosthesis (RSP) is indic Terminated |
KWS | K051075 |
| Jun 9, 2011 | Biomet, Inc. Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indica Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint ha Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients wh Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are i Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indic Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indi Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indica Terminated |
KWS | K080642 |
| Jun 9, 2011 | Biomet, Inc. Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are Terminated |
KWS | K080642 |
| Dec 22, 2010 | Encore Medical, Lp Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical Terminated |
KWS | K080402 |
| Dec 22, 2010 | Encore Medical, Lp Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical Terminated |
KWS | K080402 |
| Dec 22, 2010 | Encore Medical, Lp Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical Terminated |
KWS | K080402 |
| Dec 22, 2010 | Encore Medical, Lp Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical Terminated |
KWS | K080402 |
| Dec 16, 2010 | Biomet, Inc. Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN
Intended for total shoulder replacement in a reverse configurat Terminated |
KWS | K080642 |
| Dec 16, 2010 | Biomet, Inc. Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile, REF 115350, Biomet Orthopedics, Warsaw, IN
Intended for total shoulder replacement in a reverse configurati Terminated |
KWS | K080642 |
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | K063578 |
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 24mm, REF 42 184, S&N 75006724, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | K063578 |
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 22mm, REF 42 182, S&N 75006723, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | K063578 |
| Apr 7, 2010 | Smith & Nephew Inc PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.
The device is used as a semi-constrained, metal/polymer ceme Terminated |
KWS | K063578 |
| Feb 3, 2009 | Smith & Nephew Inc PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile
Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer Terminated |
KWS | K081016 |
| Feb 3, 2009 | Smith & Nephew Inc PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1), non-sterile
Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer Terminated |
KWS | K081016 |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Solar Shoulder Humeral Stem
These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision Terminated |
KWS | K955731 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | None listed |
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