PFSB/ELD/OMDE (Yakushokuki) Notification 1207 No.1 December ...

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compatibility with bone geometry)

• Added surface treatment (optimized area needed to achieve bone induction/conduction)

• Optimized position and size of locking screw holes on the stem side and screw holes for

greater trochanter fixation

Cemented stem

• Shaping (optimized length, volume and curvature of the distal area to achieve

compatibility with bone geometry)

(3) Optimized biocompatibility and durability required for sites on which structural load is

applied

• Mechanical safety shall be guaranteed (safety to the level approved for ready-made

prostheses shall be guaranteed)

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compatibility with bone geometry) • Added surface treatment (optimized area needed to achieve bone induction/conduction) • Optimized position and size of locking screw holes on the stem side and screw holes for greater trochanter fixation Cemented stem • Shaping (optimized length, volume and curvature of the distal area to achieve compatibility with bone geometry) (3) Optimized biocompatibility and durability required for sites on which structural load is applied • Mechanical safety shall be guaranteed (safety to the level approved for ready-made prostheses shall be guaranteed)

Page 1 and 2: PFSB/ELD/OMDE (Yakushokuki) Notific
Page 3 and 4: (Attachment 2) Guidance on Evaluati
Page 5 and 6: (2) Purpose of Use, Indications or
Page 7 and 8: (1) Design of Customized Artificial
Page 9: Appendix. Items to be Customized 1.

PFSB/ELD/OMDE (Yakushokuki) Notification 1207 No.1 December ...

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