Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 28
- Latest Decision
- 1991-07-26
Clearances · page 155 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K910957 | MASTERPIECES MICRO SYSTEM | Storz Instrument Co. | HRS | Class II | 1991-07-26 |
| K904737 | GROSS HIP FEMORAL COMPONENT | Johnson & Johnson Orthopaedics, Inc. | JDI | Class II | 1991-07-26 |
| K910186 | WYMAN SUTURE WASHER | Acu Med, Inc. | HTN | Class II | 1991-07-25 |
| K910229 | SOFT TISSUE SUTURE WASHER/3 HOLE WASHER | Depuy, Inc. | HTN | Class II | 1991-07-24 |
| K912395 | HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT | Howmedica Corp. | MEH | Class II | 1991-07-24 |
| K912762 | K-CAP-I, STERILE | Westcon Orthopedics, Inc. | LYT | Class II | 1991-07-18 |
| K904448 | TOWNLEY TOTAL KNEE (TTK) | Biopro, Inc. | JWH | Class II | 1991-07-17 |
| K911718 | M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST) | Biomet, Inc. | JDI | Class II | 1991-07-16 |
| K911685 | RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP | Biomet, Inc. | JDI | Class II | 1991-07-15 |
| K911686 | GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL | Depuy, Inc. | HSD | Class II | 1991-07-15 |
| K911595 | INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE | Dow Corning Wright | JDG | Class II | 1991-07-12 |
| K912207 | FX-CABLELOK SYSTEM | Biodynamic Technologies, Inc. | JDQ | Class II | 1991-07-09 |
| K911554 | AIM TIBIAL NAIL | Ace Medical Co. | HSB | Class II | 1991-07-08 |
| K912108 | BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS | Microaire Advanced Surgical Products | HRX | Class II | 1991-07-02 |
| K911585 | OMNIFIT II EPF HIP STEM SERIES | Osteonics Corp. | MEH | Class II | 1991-07-01 |
| K911572 | MG II POROUS COBAL T-CHROME FEMORAL COMPONENT | Zimmer, Inc. | JWH | Class II | 1991-07-01 |
| K910093 | FUTURA FEMORAL HIP STEM | O'Tec Corp. | JDI | Class II | 1991-07-01 |
| K911445 | FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM | Neoligaments, Ltd. | JDR | Class II | 1991-06-28 |
| K911902 | TEMPERLITE(TM) SAW BLADE | Sierra Surgical, Inc. | HSD | Class II | 1991-06-28 |
| K911528 | ISOLA(TM) SPINE SYSTEM - ILIAC SCREW | Acromed Corp. | KWP | Class II | 1991-06-28 |
| K911548 | ACRYL-X SYSTEM TM | Sonokinetics, Inc. | JDX | Class II | 1991-06-28 |
| K904809 | UNIVERSAL COMPRESSION SCREW | Howmedica Corp. | HWC | Class II | 1991-06-28 |
| K911684 | BIOMET COBALT-CHROME FEMORAL COMPONENTS | Biomet, Inc. | JDI | Class II | 1991-06-27 |
| K910807 | KEANE UNI KNEE SYSTEM | Depuy, Inc. | HSX | Class II | 1991-06-27 |
| K911398 | ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM | Howmedica Corp. | HWC | Class II | 1991-06-27 |
| K911373 | OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP | Osteonics Corp. | HRY | Class II | 1991-06-26 |
| K905613 | MTS KNEE SYSTEM | T & R Mfg., Inc. | JWH | Class II | 1991-06-24 |
| K905024 | TMP MANDIBULAR COMPRESSION SYSTEM | Techmedica, Inc. | HRS | Class II | 1991-06-24 |
| K910235 | PCA MTK II TOTAL KNEE SYSTEM | Howmedica Corp. | JWH | Class II | 1991-06-21 |
| K911394 | ISOLA(TM) SPINE SYSTEM--EYE ROD | Acromed Corp. | KWP | Class II | 1991-06-21 |
| K910175 | FIXATION DEVICES AND BONE PLATE | Micro Surgical Instruments Corp. | HRS | Class II | 1991-06-21 |
| K910990 | OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS | Osteonics Corp. | JWH | Class II | 1991-06-19 |
| K910128 | LEVTECH TITANIUM BONE WIRE | Levtech, Inc. | JDQ | Class II | 1991-06-18 |
| K905298 | TITAN TOTAL HIP DEVICE | Dr. Jean-Marc Guichet | JDI | Class II | 1991-06-17 |
| K911205 | ARTHROSCOPY INSTRUMENT CANNULA | Davol, Inc. | HRX | Class II | 1991-06-17 |
| K911052 | NEXUS(TM) FEMORAL HIP STEM | Dow Corning Wright | JDI | Class II | 1991-06-17 |
| K910836 | LIMA COLLARED CL STEM | Lima Intl. Corp. | JDI | Class II | 1991-06-14 |
| K905774 | THACKRAY TITANIUM MINI-PLATING SYSTEM | Depuy, Inc. | HRS | Class II | 1991-06-13 |
| K910352 | BIOPRO METAL BACKED CEMENTED ACETABULAR CUP | Biopro, Inc. | JDI | Class II | 1991-06-13 |
| K905810 | NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION | Joint Medical Products Corp. | JWH | Class II | 1991-06-12 |
| K910156 | HYDROXYAPATITE COATED PROFILE(R) HIP STEM | Depuy, Inc. | MEH | Class II | 1991-06-07 |
| K910989 | OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP | Osteonics Corp. | JWH | Class II | 1991-06-05 |
| K911026 | STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION | Sport Service, Inc. | JDR | Class II | 1991-05-29 |
| K911021 | PLATE BLADE WITH CURSOR OF L'UNION | Sport Service, Inc. | KTT | Class II | 1991-05-29 |
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT | Sgarlato Laboratories, Inc. | KWH | Class II | 1991-05-29 |
| K911031 | THE TRAMOND PIN | Sport Service, Inc. | JDR | Class II | 1991-05-29 |
| K910596 | DCW MODULAR DISTAL FEMORAL SYSTEM | Dow Corning Wright | KRO | Class II | 1991-05-29 |
| K911020 | LIGAMENTOPLASTIC STAPLE OF L'UNION | Sport Service, Inc. | JDR | Class II | 1991-05-29 |
| K911198 | TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY | Orthomet, Inc. | JWH | Class II | 1991-05-23 |
| K911197 | PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM | Orthomet, Inc. | JWH | Class II | 1991-05-23 |
| K910869 | HOWMEDICA(R) CEMETED FEMORAL COMPONENT | Howmedica Corp. | JDI | Class II | 1991-05-23 |
| K910858 | STRYKER ARTHROSCOPIC INFUSION PUMP | Stryker Corp. | HRX | Class II | 1991-05-23 |
| K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | Endotec, Inc. | KXA | Class II | 1991-05-23 |
| K910563 | P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL | Johnson & Johnson Orthopaedics, Inc. | JWH | Class II | 1991-05-23 |
| K905258 | S-ROM OBLONG ACETABULAR CUP | Joint Medical Products Corp. | JDI | Class II | 1991-05-21 |
| K910587 | MINISCOPE | Citation Medical Corp. | HRX | Class II | 1991-05-13 |
| K910662 | PS OMNIFIT NORMALIZED HIP STEM SERIES | Osteonics Corp. | JDI | Class II | 1991-05-13 |
| K910500 | HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM | Howmedica Corp. | JWH | Class II | 1991-05-06 |
| K905687 | ZIRCONIA CERAMIC MODULAR HEADS | Biomet, Inc. | LZO | Class II | 1991-04-15 |
| K910547 | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) | Turnkey Intergration USA, Inc. | LZO | Class II | 1991-04-12 |
| K910674 | FLEXMEDICS MALLEABLE CANNULA | Flexmedics | HRX | Class II | 1991-04-12 |
| K911452 | FIXATION PIN | Simpex, Inc. | HTY | Class II | 1991-04-12 |
| K911505 | FIXATION WIRE | Simpex, Inc. | HTY | Class II | 1991-04-12 |
| K910548 | FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) | Turnkey Intergration USA, Inc. | LZO | Class II | 1991-04-09 |
| K911300 | MICROSURGICAL INSTRUMENTS | Danek Medical, Inc. | HRX | Class II | 1991-04-05 |
| K910922 | OSTEONICS CDH HIP STEM | Osteonics Corp. | JDI | Class II | 1991-04-05 |
| K905514 | AUTOGENESIS(TM) AUTOMATOR | Advanced Biosearch Assn. | KTT | Class II | 1991-04-02 |
| K910083 | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES | Osteonics Corp. | HSX | Class II | 1991-04-01 |
| K904208 | KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM | Howmedica Corp. | JWH | Class II | 1991-04-01 |
| K905014 | AMSET PLD SYSTEM | Advanced Med/Surg, Inc. | HRX | Class II | 1991-04-01 |
| K910164 | ORTHOCONCEPT ARTHROSCOPIC PUMP | Orthoconcept, Inc. | HRX | Class II | 1991-03-27 |
| K910755 | PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING | Intermedics Orthopedics | MEH | Class II | 1991-03-26 |
| K905785 | ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) | Orthoconcept, Inc. | HRX | Class II | 1991-03-26 |
| K910988 | OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES | Osteonics Corp. | JDI | Class II | 1991-03-26 |
| K905786 | GLOBAL TOTAL SHOULDER | Depuy, Inc. | KWT | Class II | 1991-03-26 |
| K905826 | ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR | Acromed Corp. | KWP | Class II | 1991-03-21 |
| K904859 | MOTOR DRIVEN EXTIRPATION INSTRUMENTS | Aesculap, Inc. | HRX | Class II | 1991-03-15 |
| K905595 | ACE RECONSTRUCTIVE PLATE | Ace Medical Co. | HRS | Class II | 1991-03-14 |
| K903563 | HOWMEDICA HNR SYSTEM | Howmedica Corp. | LWJ | Class II | 1991-03-14 |
| K910010 | Q SYSTEM 28 HIP STEM | Turnkey Intergration USA, Inc. | LWJ | Class II | 1991-03-12 |
| K905577 | EXACTECH HUMERAL SHOULDER PROSTHESIS | Exactech, Inc. | HSD | Class II | 1991-03-12 |
| K905580 | TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO | Exactech, Inc. | HSD | Class II | 1991-03-12 |
| K910723 | BIODEGRADABLE SURGICAL STAPLE | Instrument Makar, Inc. | JDR | Class II | 1991-03-12 |
| K905739 | ZIMMER CERAMIC FEMORAL HEADS | Zimmer, Inc. | LZO | Class II | 1991-03-07 |
| K905451 | SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE | Advanced Osseous Technologies | JDX | Class II | 1991-03-05 |
| K910274 | ARTIFLEX(TM) | Beiersdorf, Inc. | LGF | Class I | 1991-03-05 |
| K903526 | ALTA(R) PFX IM ROD | Howmedica Corp. | HSB | Class II | 1991-03-05 |
| K905781 | APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM | Intermedics Orthopedics | MEH | Class II | 1991-03-04 |
| K905408 | NEXUS ACETABULAR CUP | Dow Corning Wright | JDI | Class II | 1991-03-01 |
| K905370 | EXACTECH BIPOLAR HIP PROSTHESIS | Exactech, Inc. | KWY | Class II | 1991-02-27 |
| K905254 | THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH | Depuy, Inc. | LWJ | Class II | 1991-02-26 |
| K904973 | EXTERNAL FIXATION | Dynasplint Systems, Inc. | KTT | Class II | 1991-02-21 |
| K905186 | GERI TOTAL HIP SYSTEM | Smith & Nephew Richards, Inc. | LWJ | Class II | 1991-02-15 |
| K905184 | ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK | Acromed Corp. | KWP | Class II | 1991-02-15 |
| K905076 | WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT | Dow Corning Wright | JWH | Class II | 1991-02-13 |
| K905260 | TOTAL HIP FEMORAL COMPONENT | Intermedics Orthopedics | LZO | Class II | 1991-01-30 |
| K905048 | ACE 3.5MM CORTICAL BONE SCREW | Ace Medical Co. | HWC | Class II | 1991-01-30 |
| K905275 | OSTEONICS(R) MPSS HIP STEM SERIES | Osteonics Corp. | JDI | Class II | 1991-01-28 |
| K904879 | BEUCHEL-PAPPAS GLENOID COMPONENT | Endotec, Inc. | KWS | Class II | 1991-01-28 |
| K904880 | BUECHEL-PAPPAS HUMERAL STEM COMPONENT | Endotec, Inc. | KWS | Class II | 1991-01-28 |
17,115 clearances in the Orthopedic panel. Data: openFDA.