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) |
|---|---|---|---|
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 52mm x 21mm, Catalog No. 0020054. 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 52mm x 18mm, Catalog No. 0020053. 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 52mm x 15mm, Catalog No. 0020052. 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 48mm x 21mm, Catalog No. 0020050. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 48mm x 18mm, Catalog No. 0020049. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 48mm x 15mm, Catalog No. 0020048. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 44mm x 21mm, Catalog No. 0020046. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 44mm x 18mm, Catalog No. 0020045. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constr Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 52mm x 21mm, Catalog No. 0020034. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 44mm x 21mm, Catalog No. 0020026. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Head Eccentric 44mm x 18mm, Catalog No. 0020025. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-const Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained g Terminated |
KWS | K060988 |
| Jan 23, 2009 | Tournier, Inc. Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained g Terminated |
KWS | K060988 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jan 15, 2009 | Depuy Orthopaedics, Inc. Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203.
The device is used as a shoulder implant. Terminated |
KWS | K062250 K081620 |
| Jun 26, 2008 | Stryker Howmedica Osteonics Corp. Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shoulder Replacement. Stryker Orthopaedics Made in USA Terminated |
KWS | K061677 |
| Dec 19, 2007 | Encore Medical, Lp Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758. Terminated |
KWS | K041066 |
| Dec 19, 2007 | Encore Medical, Lp Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758. Terminated |
KWS | K041066 |
| Nov 17, 2007 | Depuy Orthopaedics, Inc. SmartSeal Wedge Femoral Pressuriser; Product Code/Catalog No: 3206002, DePuy Orthopaedics, Inc., 700 Orthopaedics Drive, Warsaw, Indiana 46581-0988-This product allows for effective and controlled pre Terminated |
KWS | None listed |
| Nov 1, 2007 | Stryker Howmedica Osteonics Corp. ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis.
Distal Diameter - 7 to 15mm;
Hydroxylapatite coated;
Titanium Plasma Spray;
Howmedica Osteonics Corp. Terminated |
KWS | K062113 |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) device component; 40mm + 4mm RSP Socket Device; Device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) device component; RSP Socket; Device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) device component; RSP Head; Device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) device component; RSP Baseplate; Device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) device component; RSP Stem; Device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; RSP/Foundation Socket Spacer; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; RSP RSP 40mm Socket Assembly, Semi-constrained; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; RSP 40mm Poly Socket Assembly; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; 40mm Glenoid Head; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; 36mm Glenoid Head, Hooded; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; 36mm RSP Glenoid Head; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; 32mm RSP Glenoid Baseplate; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; 32mm Neutral Socket; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; 30mm RSP Glenoid Baseplate; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Sep 25, 2007 | Encore Medical, Lp Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWS | None listed |
| Aug 23, 2007 | Zimmer Inc. Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370. Terminated |
KWS | K990136 |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 56 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430605256. Terminated |
KWS | K022377 K031449 |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605200. Terminated |
KWS | K022377 K031449 |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605246. Terminated |
KWS | K022377 K031449 |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652. Terminated |
KWS | K022377 K031449 |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600. Terminated |
KWS | K022377 K031449 |
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