510(k) K192989

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

October 29, 2020

Date Received

October 25, 2019

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Device Class

Class II

Regulation Number

888.3353

Review Panel

OR

Submission Type

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.