510(k) K130652

VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT by Consensus Orthopedics, Inc. — Product Code OQG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 17, 2013
Date Received: March 12, 2013
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Device Class: Class II
Regulation Number: 888.3358
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.

Other clearances by Consensus Orthopedics, Inc.

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K163167 — CKS Plus Knee System (August 9, 2017)
K160515 — PS2 Knee System (December 19, 2016)
K143725 — Consensus Knee System Modular Tibial Baseplate (March 4, 2015)
K133919 — CONSENSUS VITALITE TIBIAL INSERT (July 14, 2014)
K141043 — CS2 MULTI-HOLE ACETABULAR SHELL (May 19, 2014)
K122512 — CS2 HIP SYSTEM (November 5, 2012)
K120595 — UNISYN PLUS HIP STEM (October 12, 2012)
K121935 — TAPERSET HIP SMALL STEMS (September 10, 2012)
K121263 — TAPER SET HIP SYSTEM RDP STEM (May 22, 2012)

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