Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K100445
KLASSIC HD HIP SYSTEM · Total Joint Orthopedics, Inc. · decided 2010-12-03 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Klassic HD Hip System Offset Femoral Stem, Porous, size 1 | 3103.01.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703011375 |
| Cancellous Bone Screw with 6.5mm Head Diameter, 45mm | 3600.45.065 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010583 |
| Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 58mm | 3501.58.032 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012433 |
| Klassic HD Hip System Femoral Stem (12/14 taper), Porous, size 2 | 3101.02.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010132 |
| Klassic HD Hip System Offset Femoral Stem, Porous, size 6 | 3103.06.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703011429 |
| Klassic HD Hip System Offset Femoral Stem, Porous, size 5 | 3103.05.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703011412 |
| Klassic HD Hip System Offset Femoral Stem, Porous, size 3 | 3103.03.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703011399 |
| Acetabular Shell with Ti-Coat, 60mm | 3400.60.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010453 |
| Acetabular Shell with Ti-Coat, 52mm | 3400.52.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010415 |
| Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 50mm | 3501.50.032 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012396 |
| Cancellous Bone Screw with 6.5mm Head Diameter, 30mm | 3600.30.065 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010552 |
| Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 56mm | 3501.56.032 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012426 |
| Klassic HD Hip System Femoral Stem (12/14 taper), Porous, size 7 | 3101.07.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010187 |
| Acetabular Insert with ApeX-Lnk Poly, 36mm Head, Size 62mm | 3501.62.036 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012525 |
| Klassic HD Hip System Offset Femoral Stem, Porous, size 2 | 3103.02.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703011382 |
| Cancellous Bone Screw with 6.5mm Head Diameter, 40mm | 3600.40.065 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010576 |
| Acetabular Insert with ApeX-Lnk Poly, 36mm Head, Size 54mm | 3501.54.036 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012488 |
| Acetabular Shell with Ti-Coat, 62mm | 3400.62.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010460 |
| Acetabular Shell with Ti-Coat, 48mm | 3400.48.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010392 |
| Acetabular Insert with ApeX-Lnk Poly, 36mm Head, Size 60mm | 3501.60.036 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012518 |
| Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 48mm | 3501.48.032 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012389 |
| Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 62mm | 3501.62.032 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703012457 |
| Acetabular Shell with Ti-Coat, 58mm | 3400.58.000 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010446 |
| Cancellous Bone Screw with 6.5mm Head Diameter, 55mm | 3600.55.065 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010606 |
| Cancellous Bone Screw with 6.5mm Head Diameter, 35mm | 3600.35.065 | TOTAL JOINT ORTHOPEDICS, INC. | LPH LWJ MBL | 00814703010569 |