510(k) K112802

PIPELINE TOTAL HIP SYSTEM by Pipeline Orthopedics — Product Code OQG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 9, 2012
Date Received: September 27, 2011
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 Pipeline Orthopedics

K131368 — NEO KNEE SYSTEM (October 3, 2013)
K132046 — PIPELINE KNEE SYSTEM (September 23, 2013)
K130353 — PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) (July 1, 2013)
K131237 — PIPELINE TOTAL HIP SYSTEM (June 13, 2013)
K123692 — PIPELINE KNEE SYSTEM (May 24, 2013)
K122500 — NEO PS KNEE SYSTEM (May 3, 2013)
K120313 — NEO CR KNEE SYSTEM (April 20, 2012)
K113122 — PIPELINE CR PRIMARY KNEE SYSTEM (March 20, 2012)

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