Home / 510(k) Clearances / K113848

510(k) K113848

R3 XLPE LINERS by Smith & Nephew, Inc. — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
December 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Smith & Nephew, Inc.

  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPT (June 25, 2025)
  • K243608 — TRIGEN Stable Lock Nut & Washer (June 12, 2025)
  • K250677 — LEGION Total Knee System (April 2, 2025)
  • K250571 — CATALYSTEM Femoral Stems (March 28, 2025)
  • K241666 — EVOS Pelvic and Acetabular System (February 19, 2025)
  • K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail (December 9, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (October 30, 2024)

Other clearances for product code MBL

  • K201157 — Prime BIOFOAM® Multi-Hole Shells (August 24, 2021)
  • K201701 — R3 HA Coated Acetabular Shells (October 6, 2020)
  • K182535 — R3 Anteverted Liners (November 19, 2018)
  • K161233 — OXINIUM DH Fermoral Heads (December 14, 2016)
  • K122382 — DYNASTY BIOFOAM SHELL (October 22, 2012)
  • K102370 — R3 XLPE ANTEVERTED LINERS (January 19, 2011)
  • K093363 — COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (January 26, 2010)
  • K092386 — R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (November 3, 2009)
  • K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (June 6, 2007)
  • K061253 — REFLECTION 3 ACETABULAR SYSTEM (May 31, 2006)