Company ยท US
Orthomet, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1995. Name variants (Inc, Corp, punctuation) are merged.
60510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 19 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 16 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 4 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 |
| HMC | Monitor, Eye Movement, Diagnostic | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 |
| JDQ | Cerclage, Fixation | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| LZN | Cement Obturator | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 7, 1995 | K936310 | ORTHOMET HMC FEMORAL STEM COMPONENT Orthomet, Inc. | LPH |
| May 30, 1995 | K945783 | ORTHOMET TITANIUM HYBRID FEMORAL STEM Orthomet, Inc. | JDG |
| Apr 26, 1995 | K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY Orthomet, Inc. | LXH |
| Dec 28, 1994 | K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT Orthomet, Inc. | KXA |
| Nov 30, 1994 | K930771 | PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM Orthomet, Inc. | JDI |
| Oct 18, 1994 | K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER Orthomet, Inc. | JWH |
| Oct 14, 1994 | K932677 | AXIOM TOTAL KNEE SYSTEM Orthomet, Inc. | JWH |
| Oct 14, 1994 | K931678 | ORTHOMET LHMC FEMORAL STEM Orthomet, Inc. | HMC |
| Oct 14, 1994 | K931333 | ORTHOMET ACETABULAR CUP SYSTEM Orthomet, Inc. | LPH |
| Jan 7, 1994 | K925536 | HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | KWY |
| Jan 7, 1994 | K923243 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Oct 27, 1993 | K924698 | AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY Orthomet, Inc. | JWH |
| Oct 22, 1993 | K930595 | AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY Orthomet, Inc. | JWH |
| Aug 25, 1993 | K924050 | TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT Orthomet, Inc. | KWL |
| Apr 6, 1993 | K922847 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Feb 9, 1993 | K922733 | PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP Orthomet, Inc. | JDI |
| Dec 24, 1992 | K915190 | PERFECTA TOTAL HIP SYSTEM, HA COATED Orthomet, Inc. | MEH |
| Dec 7, 1992 | K923583 | ORTHOMET PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | LZO |
| Nov 6, 1992 | K921836 | PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD Orthomet, Inc. | LZO |
| Nov 4, 1992 | K923909 | CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL Orthomet, Inc. | LZN |
| Sep 10, 1992 | K922734 | AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM Orthomet, Inc. | JWH |
| Aug 3, 1992 | K920698 | FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS Orthomet, Inc. | JWH |
| Aug 3, 1992 | K920426 | PSK FEMORAL AND TIBIAL INSERT COMPONENT Orthomet, Inc. | JWH |
| Mar 23, 1992 | K915868 | PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT Orthomet, Inc. | KWL |
| Mar 4, 1992 | K915795 | PERFECTA PDA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Dec 16, 1991 | K914230 | AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY Orthomet, Inc. | JWH |
| Oct 18, 1991 | K912894 | AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT Orthomet, Inc. | JWH |
| May 23, 1991 | K911198 | TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY Orthomet, Inc. | JWH |
| May 23, 1991 | K911197 | PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM Orthomet, Inc. | JWH |
| Nov 9, 1990 | K903635 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Jul 6, 1990 | K895145 | SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR Orthomet, Inc. | JWH |
| Jul 3, 1990 | K901936 | PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP Orthomet, Inc. | JWH |
| Jun 18, 1990 | K902259 | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT Orthomet, Inc. | JWX |
| May 22, 1990 | K901328 | DOMED AND FINNED ACETABULAR COMPONENT Orthomet, Inc. | JDI |
| Nov 20, 1989 | K893040 | ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG Orthomet, Inc. | JWH |
| Oct 6, 1989 | K894334 | SECOND GENERATION KNEE SYSTEM Orthomet, Inc. | JWH |
| Sep 15, 1989 | K893762 | PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT Orthomet, Inc. | JWH |
| May 23, 1989 | K892398 | BIPOLAR HIP SYSTEM Orthomet, Inc. | KXA |
| May 10, 1989 | K890742 | INTRAFORM TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Apr 7, 1989 | K884027 | PERFECTA II/NON-COATED TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Jan 27, 1989 | K884585 | LEA PLAZA SPINAL FRAME SYSTEM Orthomet, Inc. | KWP |
| Dec 28, 1988 | K883618 | PERFECTA II TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Nov 30, 1988 | K883941 | PROFORMA HIP SYSTEM Orthomet, Inc. | JDI |
| Jun 29, 1988 | K880435 | PROFORMA/PS TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Apr 5, 1988 | K880390 | INTRAFORM TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Mar 15, 1988 | K880461 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Feb 18, 1988 | K880004 | TOWNLEY COX COMB ACETABULAR CUP Orthomet, Inc. | JDI |
| Feb 17, 1988 | K875201 | PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG Orthomet, Inc. | JWH |
| Feb 4, 1988 | K874914 | ORTHOMET ORTHOPEDIC STAPLES Orthomet, Inc. | JDR |
| Feb 3, 1988 | K874915 | ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS Orthomet, Inc. | KWL |
Newest 50 of 60.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||