Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2000-12-11
Clearances · page 125 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K994146 | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP | Plus Orthopedics | LWJ | Class II | 2000-12-11 |
| K001160 | VERSABOND BONE CEMENT | Smith & Nephew, Inc. | LOD | Class II | 2000-12-11 |
| K002960 | TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 | Zimmer, Inc. | LPH | Class II | 2000-12-11 |
| K003490 | OPUS ROD FIXATION SYSTEM | Howmedica Osteonics Corp. | MNH | Class II | 2000-12-08 |
| K002783 | FIXION INTERLOCKING NAIL (FIXION IL NAIL) | Disco-O-Tech Medical Technologies, Ltd. | HSB | Class II | 2000-12-05 |
| K002775 | DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | HRS | Class II | 2000-12-05 |
| K002755 | NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE | T. Korossurgical Instruments Corp. | LRN | Class II | 2000-12-04 |
| K002941 | ACETABULAR PLATES | Encore Orthopedics, Inc. | LWJ | Class II | 2000-12-04 |
| K994078 | U1 HIP SYSTEM | United Orthopedic Corp. | LPH | Class II | 2000-12-04 |
| K003421 | DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | JDI | Class II | 2000-12-01 |
| K003429 | MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL | Biomet, Inc. | LPH | Class II | 2000-11-30 |
| K003379 | V-40/C-TAPER ADAPTER SLEEVE | Howmedica Osteonics Corp. | LZO | Class II | 2000-11-30 |
| K002740 | TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS | Smith & Nephew, Inc. | JWH | Class II | 2000-11-30 |
| K003391 | OSTEONICS ALUMINA C-TAPER HEAD | Howmedica Osteonics Corp. | LZO | Class II | 2000-11-28 |
| K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR | Hydrocision, Inc. | HRX | Class II | 2000-11-24 |
| K003413 | ALUMINA V40 HEAD | Howmedica Osteonics Corp. | LZO | Class II | 2000-11-24 |
| K002184 | COD COMPRESSION OSTEOTOMY DEVICE | Walter Abendschein, M.D. | HRS | Class II | 2000-11-24 |
| K003428 | ISS OFFSET HEADS | Biomet, Inc. | HSD | Class II | 2000-11-24 |
| K002931 | METRX SYSTEM | Medtronic Sofamor Danek, Inc. | HRX | Class II | 2000-11-24 |
| K002757 | ONCOLOGY SALVAGE SYSTEM | Biomet, Inc. | JDI | Class II | 2000-11-24 |
| K003384 | VERSALINK TITANIUM ROD-TO-ROD COUPLERS | Osteotech, Inc. | MNH | Class II | 2000-11-24 |
| K002683 | WMT ULTRA-FIT MODULAR SHOULDER SYSTEM | Wrightmedicaltechnologyinc | KWS | Class II | 2000-11-22 |
| K002605 | 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW | Synthes (Usa) | JDW | Class II | 2000-11-20 |
| K002644 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | KWI | Class II | 2000-11-20 |
| K002600 | LITWIN CRUICATE ANCHOR | Instrument Makar, Inc. | MBI | Class II | 2000-11-15 |
| K002575 | INTER-OP DURASUL ACETABULAR INSERTS (4MM) | Sulzer Orthopedics, Inc. | LWJ | Class II | 2000-11-15 |
| K002552 | HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE | Howmedica Osteonics Corp. | KRO | Class II | 2000-11-13 |
| K002059 | AMT SPINAL SYSTEM | Micron Precision Engineering, Inc. | KWP | Class II | 2000-11-13 |
| K002486 | PRECIMED TRAUMA SYSTEM | Patrick Berdoz | HRS | Class II | 2000-11-09 |
| K003181 | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ | Implex Corp. | LPH | Class II | 2000-11-07 |
| K003296 | BIOMET SCK KNEE SYSTEM | Biomet, Inc. | JWH | Class II | 2000-11-06 |
| K003235 | PE.R.I. II KNEE FRACTURE SYSTEM | DePuy Orthopaedics, Inc. | HRS | Class II | 2000-11-06 |
| K003294 | BIOMET LATERAL TROCH PLATE | Biomet, Inc. | JDW | Class II | 2000-11-03 |
| K001044 | ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM | Acme Spine, LLC | MNH | Class II | 2000-11-03 |
| K003131 | MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | JDW | Class II | 2000-11-02 |
| K002103 | SIMPLICITY SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | KWP | Class II | 2000-11-02 |
| K002362 | SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) | Synthes (Usa) | MQV | Class II | 2000-11-01 |
| K002361 | SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM | Synthes (Usa) | HRS | Class II | 2000-10-31 |
| K002325 | WUJIN #3 TIBIAL NAIL | Biologically Oriented Prostheses | JDS | Class II | 2000-10-30 |
| K002356 | NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS | Sulzer Orthopedics, Inc. | KRR | Class II | 2000-10-30 |
| K003061 | SYNTHES USS (10.0MM SIDE OPENING SCREWS) | Synthes | KWQ | Class II | 2000-10-30 |
| K003076 | MITEK CUFFTACK | Mitek Products | MAI | Class II | 2000-10-27 |
| K002335 | NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA | Sulzer Orthopedics, Inc. | JWH | Class II | 2000-10-25 |
| K002278 | BROOKER FEMORAL NAILS | Biomet Orthopedics, Inc. | HSB | Class II | 2000-10-23 |
| K002980 | MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM | Ebi, L.P. | KWQ | Class II | 2000-10-23 |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | Radionics, Inc. | HRX | Class II | 2000-10-23 |
| K001668 | GLOBAL SPINAL FIXATION SYSTEM | D.K.M. Co., Ltd. | MNH | Class II | 2000-10-19 |
| K994121 | SMALL STATURE USS | Synthes (Usa) | MNI | Class II | 2000-10-17 |
| K002959 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Encore Orthopedics, Inc. | KWP | Class II | 2000-10-16 |
| K002858 | XIA SPINE SYSTEM | Howmedica Osteonics Corp. | KWQ | Class II | 2000-10-13 |
| K002883 | PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | KWA | Class III | 2000-10-13 |
| K000666 | TC-PLUS SOLUTION KNEE | Plus Orthopedics | JWH | Class II | 2000-10-13 |
| K002125 | PINS AND WIRES | Implant Resource, Inc. | HTY | Class II | 2000-10-11 |
| K002082 | SPEEDLINK TRANSVERSE CONNECTOR | Spinal Concepts, Inc. | KWP | Class II | 2000-10-06 |
| K002110 | SPL CRIMP SYSTEM | Pioneer Surgical Technology | JDQ | Class II | 2000-10-06 |
| K002998 | BIOMET BI-POLAR SHOULDER SYSTEM | Biomet, Inc. | KWT | Class II | 2000-10-06 |
| K002592 | INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM | Interpore Cross Intl. | KWQ | Class II | 2000-10-06 |
| K002729 | SYNTHES PROXIMAL HUMERAL NAIL | Synthes (Usa) | JDS | Class II | 2000-10-06 |
| K002069 | ASCEND SPINAL FIXATION SYSTEM | Spinal Innovations, LLC | KWP | Class II | 2000-10-05 |
| K002505 | XIA SPINE SYSTEM | Howmedica Osteonics Corp. | KWP | Class II | 2000-10-05 |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | JDX | Class II | 2000-10-04 |
| K002772 | ASCENT XXL CLOSED BOX FEMORAL COMPONENT | Biomet, Inc. | JWH | Class II | 2000-10-04 |
| K002057 | BROOKER TIBIA NAILS | Biomet Orthopedics, Inc. | HSB | Class II | 2000-10-04 |
| K002437 | ENDIUS ENDOSCOPIC ACCESS SYSTEM | Endius, Inc. | HRX | Class II | 2000-10-02 |
| K000003 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | JDC | Class II | 2000-10-02 |
| K002710 | MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) | Synthes (Usa) | HRS | Class II | 2000-09-29 |
| K002796 | MODIFICATION TO PROVIDENT HIP SYSTEM | Stelkast Company | LWJ | Class II | 2000-09-28 |
| K002399 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | MNH | Class II | 2000-09-27 |
| K001984 | PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT | Stelkast Company | JDG | Class II | 2000-09-27 |
| K001941 | SYNTHES MODULAR FOOT SYSTEM | Synthes (Usa) | HRS | Class II | 2000-09-22 |
| K001945 | SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES | Synthes (Usa) | HRS | Class II | 2000-09-22 |
| K002654 | HOWMEDICA OSTEONICS SHOULDER SCREW | Howmedica Osteonics Corp. | HWC | Class II | 2000-09-22 |
| K002413 | ULTRASORB SUTURE ANCHOR | Li Medical Technologies, Inc. | MAI | Class II | 2000-09-19 |
| K002735 | ASCENT XXL OPEN BOX FEMORAL COMPONENT | Biomet, Inc. | JWH | Class II | 2000-09-19 |
| K002678 | ASCENT KNEE SYSTEM | Biomet, Inc. | JWH | Class II | 2000-09-19 |
| K001918 | KSEA PERCUTANEOUS FORAMINOSCOPY SET | KARL STORZ Endoscopy-America, Inc. | HRX | Class II | 2000-09-19 |
| K002371 | K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM | Spineology, Inc. | KWQ | Class II | 2000-09-15 |
| K000515 | PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, | Interpore Cross Intl. | MQV | Class II | 2000-09-15 |
| K002320 | ACCOLADE C FEMORAL COMPONENT | Howmedica Osteonics Corp. | LZO | Class II | 2000-09-14 |
| K002517 | USS VAS | Synthes (Usa) | KWP | Class II | 2000-09-12 |
| K002607 | MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS | Depuyacromed | KWP | Class II | 2000-09-12 |
| K002040 | FMS SOLO | Future Medical Systems, Inc. | HRX | Class II | 2000-09-11 |
| K002441 | FENNING HIP STEM | DePuy Orthopaedics, Inc. | LZO | Class II | 2000-09-01 |
| K002149 | LINEAGE ACETABULAR SYSTEM | Wrightmedicaltechnologyinc | LPH | Class II | 2000-08-31 |
| K994041 | TORNIER BIPOLAR RADIAL HEAD PROSTHESIS | Tornier, Inc. | KWI | Class II | 2000-08-31 |
| K001760 | RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | LXT | Class II | 2000-08-31 |
| K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM | Mitek Products | HRX | Class II | 2000-08-31 |
| K002379 | M2A 28MM RINGLOC LINER | Biomet, Inc. | KWA | Class III | 2000-08-31 |
| K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 | Pioneer Surgical Technology | JDQ | Class II | 2000-08-31 |
| K001938 | VECTOR TARGETING SYSTEM | Vector Medical, Inc. | HSB | Class II | 2000-08-29 |
| K001922 | DEPUY NEUFLEX PIP FINGER | Depuy, Inc. | KYJ | Class II | 2000-08-29 |
| K002271 | 2.4MM CORTEX SCREW, SELF-TAPPING | Synthes (Usa) | HWC | Class II | 2000-08-25 |
| K002070 | BIOLOK SCREW | Biocomposites, Ltd. | HWC | Class II | 2000-08-25 |
| K001991 | TITAN POROCOAT HIP PROSTHESIS | DePuy Orthopaedics, Inc. | LPH | Class II | 2000-08-25 |
| K002020 | LACTOSORB MENISCAL SCREW | Biomet Manufacturing, Inc. | MAI | Class II | 2000-08-25 |
| K002324 | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA | Sulzermedica | JDI | Class II | 2000-08-24 |
| K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | Implex Corp. | JDI | Class II | 2000-08-24 |
| K001720 | SYNTHES SACRAL BAR SYSTEM | Synthes (Usa) | JDW | Class II | 2000-08-24 |
| K001847 | ANTERIOR CERVICAL PLATE SYSTEM | Encore Orthopedics, Inc. | KWQ | Class II | 2000-08-24 |
| K001653 | XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY | Howmedica Osteonics Corp. | KWP | Class II | 2000-08-18 |
17,115 clearances in the Orthopedic panel. Data: openFDA.