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510(k) K060438

RHS by Tornier — Product Code JDB

K060438 is an FDA 510(k) premarket notification submitted by Tornier for the device "RHS". The FDA issued a decision of Substantially Equivalent on April 18, 2006. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Tornier has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2006
Date Received
February 21, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device Class
Class II
Regulation Number
888.3160
Review Panel
OR
Submission Type

Other clearances by Tornier

  • K252788 — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
  • K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max) (October 30, 2025)
  • K232265 — BLUEPRINT™ Patient Specific Instrumentation (February 21, 2024)
  • K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail (October 31, 2023)
  • K222510 — Blueprint Mixed Reality system (January 20, 2023)
  • DEN220012 — Tornier Pyrocarbon Humeral Head (December 16, 2022)
  • K220914 — Tornier Perform Humeral System – Fracture (October 14, 2022)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K211359 — Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient (November 12, 2021)
  • K213124 — Tomier Perform™ Reversed Glenoid Cannulated Glenospheres (October 26, 2021)

Other clearances for product code JDB

  • K222807 — TEMA Elbow system - Line extension (October 26, 2022)
  • K193247 — LATITUDE EV™ Total Elbow Arthroplasty (August 5, 2020)
  • K182461 — LATITUDE EV Total Elbow Arthroplasty (December 27, 2018)
  • K171010 — Latitude EV Total Elbow Arthroplasty (August 31, 2017)
  • K102180 — RHEAD RADIAL HEAD EXTENDED STEMS (December 20, 2010)
  • K100562 — LATITUDE ELBOW PROSTHESIS (June 29, 2010)
  • K070787 — LATITUDE ELBOW PROTHESIS (August 24, 2007)
  • K070236 — SBI LATERAL RADIO CAPITELLUM (February 21, 2007)
  • K060038 — SBI RADIO-CAPITELLAR IMPLANT (March 30, 2006)
  • K050848 — TORNIER ELBOW PROSTHESIS (July 14, 2005)

FDA data resources