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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

K173104 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly". The FDA issued a decision of Substantially Equivalent on October 27, 2017. The device falls under product code OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented), a Class II device regulated under 21 CFR 888.3358. Total Joint Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Total Joint Orthopedics, Inc.

  • K220483 — Platform® Acetabular System (September 23, 2022)
  • K211877 — Klassic Knee System (June 22, 2022)
  • K211602 — Klassic Knee System (July 23, 2021)
  • K202740 — Klassic Knee System Tibial Inserts, PS-Max (October 9, 2020)
  • K183596 — Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS (March 29, 2019)
  • K190280 — Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - (March 15, 2019)
  • K180929 — Klassic HD® Hip System (May 9, 2018)
  • K180159 — Klassic® Knee System (March 9, 2018)
  • K162422 — Klassic Knee System (October 28, 2016)
  • K162256 — Klassic Femur, Porous, Klassic Tibial Baseplate, Porous (October 27, 2016)

Other clearances for product code OQG

  • K202705 — Prime and DYNASTY® Additive Manufacturing Shells (August 20, 2021)
  • K203472 — KMTI Hip Replacement System (April 2, 2021)
  • K201660 — KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shel (July 16, 2020)
  • 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)

FDA data resources