Plus Orthopedics
San Diego, CA, US
Plus Orthopedics appears in FDA device records in San Diego, CA. FDA records list 43 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 22 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Plus Orthopedics carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Plus Orthopedics USArecall
510(k) clearance history
FDA records hold 43 510(k) clearances for Plus Orthopedics between 1997 and 2007. The busiest year on record is 2002, with 8. The most recent is 2007, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 6 |
| 2001 | 7 |
| 2002 | 8 |
| 2003 | 8 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070928 | CERAMIC BALL HEADS, 28, 32 AND 36 MM | LZO | Substantially Equivalent | |
| K070731 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM | HAW | Substantially Equivalent | |
| K070278 | POLARCUP DUAL MOBILITY SYSTEM | LPH | Substantially Equivalent | |
| K063578 | PROMOS MODULAR SHOULDER SYSTEM | HSD | Substantially Equivalent | |
| K061362 | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM | HAW | Substantially Equivalent | |
| K032126 | PROMOS SHOULDER | HSD | Substantially Equivalent | |
| K033763 | MODIFICATION TO SLIM GLIDING NAIL SYSTEM | KTT | Substantially Equivalent | |
| K032709 | MODULAR PLUS HIP STEM | LWJ | Substantially Equivalent | |
| K032548 | IP-XS COMPRESSION NAIL SYSTEM | HSB | Substantially Equivalent | |
| K032215 | VKS/TC-PLUS REVISION KNEE | JWH | Substantially Equivalent | |
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE | HRY | Substantially Equivalent | |
| K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM | JDI | Substantially Equivalent | |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | LWJ | Substantially Equivalent | |
| K024134 | UNI HIP STEM | LWJ | Substantially Equivalent | |
| K023667 | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE | KRO | Substantially Equivalent | |
| K023416 | MODIFICATION TO VKS KNEE SYSTEM | JWH | Substantially Equivalent | |
| K022204 | VKS KNEE SYSTEM | JWH | Substantially Equivalent | |
| K022120 | MPF ACETABULAR CUP GENERATION 2 | LZO | Substantially Equivalent | |
| K021714 | RT-PLUS PE INSERT CLAMP | KRO | Substantially Equivalent | |
| K020298 | GALILEO CAS/NAV TKR SYSTEM | HAW | Substantially Equivalent | |
| K021178 | SL-PLUS LATERALIZED STEM | JDI | Substantially Equivalent | |
| K020240 | SLIM GLIDING NAIL SYSTEM | KTT | Substantially Equivalent | |
| K013340 | RT-PLUS KNEE ADDITIONAL COMPONENTS | KRO | Substantially Equivalent | |
| K011836 | MPF ACETABULAR CUP | LZO | Substantially Equivalent | |
| K011719 | PLUS CANCELLOUS BONE SCREWS | HWC | Substantially Equivalent | |
| K011288 | TC-PLUS POROUS TIBIAL COMPONENTS | JWH | Substantially Equivalent | |
| K011258 | TC-PLUS POROUS FEMORAL COMPONENTS | JWH | Substantially Equivalent | |
| K003504 | RT-PLUS MODULAR CEMENTED KNEE COMPONENTS | KRO | Substantially Equivalent | |
| K003274 | LPC-PLUS ACETABULAR CUP | LZO | Substantially Equivalent | |
| K994146 | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP | LWJ | Substantially Equivalent | |
| K000666 | TC-PLUS SOLUTION KNEE | JWH | Substantially Equivalent | |
| K001942 | SL-PLUS AND SLR-PLUS STEMS | LWJ | Substantially Equivalent | |
| K993874 | BOFOR REVISION COUP | LZO | Substantially Equivalent | |
| K994126 | MODULAR-PLUS REVISION STEM | LWJ | Substantially Equivalent | |
| K992154 | BICON-PLUS ACETABULAR COMPONENTS | LPH | Substantially Equivalent | |
| K992153 | PE-PLUS ACETABULAR CUP | JDI | Substantially Equivalent | |
| K990261 | PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) | LZO | Substantially Equivalent | |
| K982859 | UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM | HRY | Substantially Equivalent | |
| K990309 | PLUS FRACTURE HEAD PROSTHESIS | KWL | Substantially Equivalent | |
| K982447 | PLUS BIPOLAR PROSTHESIS COCRMO | KWY | Substantially Equivalent | |
| K974409 | FRIEDL GLIDING NAIL SYSTEM | KTT | Substantially Equivalent | |
| K973077 | PLUS-FIT ACETABULAR CUP | LWJ | Substantially Equivalent | |
| K973098 | COMPRESSION CERCLAGE GUNDOLF CCG-GF | JDQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- JDQCerclage, Fixation
- HAWNeurological Stereotaxic Instrument
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0362-2008 | 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; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 1214335 YKS Tibial Prep Guide, Right/Left, Size 5 Lot Code EM), Plus Orthopedics | The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter. | Terminated | ||
| Z-0361-2008 | VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121 | Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert. | Terminated | ||
| Z-0192-2007 | 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 | The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003. | Terminated | ||
| Z-0191-2007 | 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 | There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component. | Terminated | ||
| Z-0149-2007 | Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226 | Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage. | Terminated | ||
| Z-0928-06 | 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 Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays. | PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments. | Terminated | ||
| Z-0397-06 | VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument) | The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification. | Terminated | ||
| Z-0019-06 | TC-PLUS Tibial Insert UC 10; 11mm, Model 25457 | Did not meet specifications. | Terminated | ||
| Z-0018-06 | TC-PLUS Tibial Insert UC 6; 13mm, Model 25438 | Did not meet specifications. | Terminated | ||
| Z-0017-06 | TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436 | Did not meet specifications. | Terminated | ||
| Z-0016-06 | TC-PLUS Tibial Insert UC 4; 13mm, Model 25428 | Did not meet specifications. | Terminated | ||
| Z-0015-06 | TC-PLUS Tibial Insert UC 4; 11mm, Model 25427 | Did not meet specifications. | Terminated | ||
| Z-0014-06 | TC-PLUS Tibial Insert 2; 15mm, Model 25309 | Did not meet specifications. | Terminated | ||
| Z-0013-06 | TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456 | Did not meet specifications. | Terminated | ||
| Z-0924-05 | Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807 | Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long. | Terminated | ||
| Z-0126-06 | TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8. | Labeling discrepancy. | Terminated | ||
| Z-0540-05 | UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm | Knee tibial insert is mislabeled completely as different device. | Terminated | ||
| Z-0710-04 | Biolox Ceramic Head XL | Ceramic femoral ball heads break. | Terminated | ||
| Z-0339-04 | Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem. | Design Change | Terminated | ||
| Z-0107-04 | 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. | Plastic insert over articular surface of knee joint replacement may become dislodged. | Terminated | ||
| Z-0360-2008 | Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121 | The device was produced without the required distal locking hole | Terminated | ||
| Z-0170-04 | TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635. | Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain