| ASTM F2068-15 Standard Specification for Femoral Prostheses - Metallic Implants |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 11-299 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads.
1.2 Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by this specification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification.
1.3 Femoral prostheses included within the scope of this specification are intended for fixation by press fit between the prosthesis and host bone, the use of bone cement, or through the ingrowth of host bone into a porous coating.
1.4 Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification.
1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or porous-polymer coatings, are specifically excluded from the scope of this specification.
1.6 The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this specification.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3390 | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | KWY |
| §888.3360 | Prosthesis, Hip, Femoral Component, Cemented, Metal | Class 2 | JDG |
| §888.3360 | Prosthesis, Hip, Hemi-, Femoral, Metal | Class 2 | KWL |
| §888.3360 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | LWJ |
| §888.3360 | Prosthesis, Upper Femoral | Class 2 | JDD |
| §888.3360 | Prosthesis, Hip, Hemi-, Femoral, Metal | Class 2 | KWL |
| §888.3358 | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class 2 | OQG |
| §888.3358 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class 2 | LPH |
| §888.3358 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class 2 | MBL |
| §888.3353 | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class 2 | OQI |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Class 2 | MAY |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | LZO |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class 2 | MEH |
| §888.3350 | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Class 2 | OQH |
| §888.3350 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class 2 | JDI |
| §888.3340 | Prosthesis, Hip, Semi-Constrained, Composite/Metal | Class 2 | KMC |
| §888.3330 | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Class 3 | KWA |
| §888.3320 | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Class 3 | JDL |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class 2 | KWZ |
| §888.3300 | Prosthesis, Hip, Constrained, Metal | Class 3 | KXD |
| Unclassified | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented | Class 3 | LPF |
| Unclassified | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Class 3 | MRA |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | LZO |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class 2 | MEH |
| §888.3360 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | LWJ |
| Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses, September 17, 2007 |