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510(k) K130652

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

K130652 is an FDA 510(k) premarket notification submitted by Consensus Orthopedics, Inc. for the device "VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT". The FDA issued a decision of Substantially Equivalent on December 17, 2013. 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. Consensus Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K170344 — Tahoe Uni Knee System (October 5, 2017)
  • 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)

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)
  • K173104 — Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile (October 27, 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)

FDA data resources