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510(k) K173104

Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly by Total Joint Orthopedics, Inc. — Product Code OQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2017
Date Received
September 29, 2017
Clearance Type
Special
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.

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  • K200328 — Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular C (March 11, 2020)
  • K172651 — FMP Extended Liners (December 13, 2017)
  • K171543 — Renovis Surgical Hip Replacement System (November 16, 2017)
  • K143647 — Renovis Surgical Hip Replacement System (May 11, 2015)
  • K140130 — X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE H (November 6, 2014)
  • K141972 — KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY (October 9, 2014)
  • K140701 — NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG (June 27, 2014)