Company ยท US
Plus Orthopedics
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2007. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 20 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 8 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 7 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 5 |
| HAW | Neurological Stereotaxic Instrument | 4 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| JDQ | Cerclage, Fixation | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2007 | K070928 | CERAMIC BALL HEADS, 28, 32 AND 36 MM Plus Orthopedics AG | LZO |
| Jul 31, 2007 | K070731 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM Plus Orthopedics AG | HAW |
| Apr 16, 2007 | K070278 | POLARCUP DUAL MOBILITY SYSTEM Plus Orthopedics AG | LPH |
| Mar 2, 2007 | K063578 | PROMOS MODULAR SHOULDER SYSTEM Plus Orthopedics AG | HSD |
| Oct 6, 2006 | K061362 | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM Plus Orthopedics AG | HAW |
| Jan 8, 2004 | K032126 | PROMOS SHOULDER Plus Orthopedics | HSD |
| Dec 18, 2003 | K033763 | MODIFICATION TO SLIM GLIDING NAIL SYSTEM Plus Orthopedics | KTT |
| Sep 23, 2003 | K032709 | MODULAR PLUS HIP STEM Plus Orthopedics | LWJ |
| Sep 10, 2003 | K032548 | IP-XS COMPRESSION NAIL SYSTEM Plus Orthopedics | HSB |
| Aug 8, 2003 | K032215 | VKS/TC-PLUS REVISION KNEE Plus Orthopedics | JWH |
| Jul 25, 2003 | K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE Plus Orthopedics | HRY |
| Jun 6, 2003 | K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM Plus Orthopedics | JDI |
| Apr 24, 2003 | K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM Plus Orthopedics | LWJ |
| Jan 15, 2003 | K024134 | UNI HIP STEM Plus Orthopedics | LWJ |
| Dec 24, 2002 | K023667 | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE Plus Orthopedics | KRO |
| Nov 8, 2002 | K023416 | MODIFICATION TO VKS KNEE SYSTEM Plus Orthopedics | JWH |
| Oct 18, 2002 | K022204 | VKS KNEE SYSTEM Plus Orthopedics | JWH |
| Jul 24, 2002 | K022120 | MPF ACETABULAR CUP GENERATION 2 Plus Orthopedics | LZO |
| Jun 21, 2002 | K021714 | RT-PLUS PE INSERT CLAMP Plus Orthopedics | KRO |
| May 20, 2002 | K020298 | GALILEO CAS/NAV TKR SYSTEM Plus Orthopedics | HAW |
| May 14, 2002 | K021178 | SL-PLUS LATERALIZED STEM Plus Orthopedics | JDI |
| Feb 22, 2002 | K020240 | SLIM GLIDING NAIL SYSTEM Plus Orthopedics | KTT |
| Dec 20, 2001 | K013340 | RT-PLUS KNEE ADDITIONAL COMPONENTS Plus Orthopedics | KRO |
| Sep 7, 2001 | K011836 | MPF ACETABULAR CUP Plus Orthopedics | LZO |
| Jul 2, 2001 | K011719 | PLUS CANCELLOUS BONE SCREWS Plus Orthopedics | HWC |
| May 24, 2001 | K011288 | TC-PLUS POROUS TIBIAL COMPONENTS Plus Orthopedics | JWH |
| May 24, 2001 | K011258 | TC-PLUS POROUS FEMORAL COMPONENTS Plus Orthopedics | JWH |
| May 11, 2001 | K003504 | RT-PLUS MODULAR CEMENTED KNEE COMPONENTS Plus Orthopedics | KRO |
| Apr 6, 2001 | K003274 | LPC-PLUS ACETABULAR CUP Plus Orthopedics | LZO |
| Dec 11, 2000 | K994146 | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP Plus Orthopedics | LWJ |
| Oct 13, 2000 | K000666 | TC-PLUS SOLUTION KNEE Plus Orthopedics | JWH |
| Jul 25, 2000 | K001942 | SL-PLUS AND SLR-PLUS STEMS Plus Orthopedics | LWJ |
| Jun 5, 2000 | K993874 | BOFOR REVISION COUP Plus Orthopedics | LZO |
| May 4, 2000 | K994126 | MODULAR-PLUS REVISION STEM Plus Orthopedics | LWJ |
| Apr 6, 2000 | K992154 | BICON-PLUS ACETABULAR COMPONENTS Plus Orthopedics | LPH |
| Sep 23, 1999 | K992153 | PE-PLUS ACETABULAR CUP Plus Orthopedics | JDI |
| Aug 27, 1999 | K990261 | PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) Plus Orthopedics | LZO |
| Jul 30, 1999 | K982859 | UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM Plus Orthopedics | HRY |
| Mar 15, 1999 | K990309 | PLUS FRACTURE HEAD PROSTHESIS Plus Orthopedics | KWL |
| Nov 25, 1998 | K982447 | PLUS BIPOLAR PROSTHESIS COCRMO Plus Orthopedics | KWY |
| Feb 19, 1998 | K974409 | FRIEDL GLIDING NAIL SYSTEM Plus Orthopedics | KTT |
| Nov 13, 1997 | K973077 | PLUS-FIT ACETABULAR CUP Plus Orthopedics | LWJ |
| Oct 27, 1997 | K973098 | COMPRESSION CERCLAGE GUNDOLF CCG-GF Plus Orthopedics | JDQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2007 | Plus Orthopedics USA VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 121433 Terminated |
JWH | None listed |
| Dec 8, 2007 | Plus Orthopedics USA VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121 Terminated |
JWH | K022204 |
| Dec 8, 2007 | Plus Orthopedics USA Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121 Terminated |
KTT | K020240 |
| Nov 16, 2006 | Plus Orthopedics USA UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10 Terminated |
HRY | K032052 |
| Nov 16, 2006 | Plus Orthopedics USA UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006
Femoral Component Size 6, 26008 Femoral Component Size 8 and 26010 Femoral Component Size 10 Terminated |
HRY | K982859 |
| Nov 8, 2006 | Plus Orthopedics USA Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226 Terminated |
HAW | K020298 |
| Jun 2, 2006 | Plus Orthopedics USA Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument:
1130020-A: GNp Carbon Targeting Handle
1130021-A: GN Ad Terminated |
KTT | None listed |
| Jan 18, 2006 | Plus Orthopedics USA VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument) Terminated |
JWH | K022204 |
| Nov 3, 2005 | Plus Orthopedics USA TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8. Terminated |
JWH | K000666 |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 10; 11mm, Model 25457 Terminated |
JWH | K000666 |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 6; 13mm, Model 25438 Terminated |
JWH | K000666 |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436 Terminated |
JWH | K000666 |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 4; 13mm, Model 25428 Terminated |
JWH | K000666 |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 4; 11mm, Model 25427 Terminated |
JWH | K000666 |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert 2; 15mm, Model 25309 Terminated |
JWH | K000666 |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456 Terminated |
JWH | K000666 |
| Jun 22, 2005 | Plus Orthopedics USA Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807 Terminated |
JWH | K022204 |
| Feb 15, 2005 | Plus Orthopedics UltraCongruent Tibial Insert Model 0214703
Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm Terminated |
JWH | K022204 |
| Jul 20, 2004 | Plus Orthopedics Biolox Ceramic Head XL Terminated |
LZO | None listed |
| Jan 14, 2004 | Plus Orthopedics Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem. Terminated |
LWJ | None listed |
| Nov 27, 2003 | Plus Orthopedics TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635. Terminated |
JWH | None listed |
| Nov 13, 2003 | Plus Orthopedics 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant.
Part of the ''RT/RT Modular'' total knee replacement. Terminated |
KRO | None listed |