1.1 This guide covers general guidelines for the physical, chemical, biocompatibility, mechanical, and preclinical assessments of ultra-high molecular weight polyethylene (UHMWPE) in implantable orthopedic and spinal devices intended to replace a musculoskeletal joint. The UHMWPE components may include knee, hip, shoulder, elbow, ankle, total disc replacement, toe, finger, and wrist joint implant devices. This guide does not cover UHMWPE in fiber or tape forms.
Product Details
- Published:
- 12/01/2019
- Number of Pages:
- 6
- File Size:
- 1 file , 250 KB
- Redline File Size:
- 2 files , 530 KB
