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510(k) K954213

ATH FULL PROFILE ACETABULAR CUP SYSTEM by Kinamed, Inc. — Product Code LPH

K954213 is an FDA 510(k) premarket notification submitted by Kinamed, Inc. for the device "ATH FULL PROFILE ACETABULAR CUP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 25, 1995. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Kinamed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1995
Date Received
September 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Kinamed, Inc.

  • K122049 — NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM (April 5, 2013)
  • K072250 — SUPERCABLE GRIP AND PLATE SYSTEM (November 9, 2007)
  • K050897 — NAVIPRO SHOULDER SOFTWARE MODULE (May 24, 2005)
  • K033668 — NAVIPRO KNEE SOFTWARE MODULE (March 11, 2004)
  • K032950 — GEM INSET PATELLAR COMPONENT (December 19, 2003)
  • K030256 — ISO-ELASTIC CERCLAGE SYSTEM (October 21, 2003)
  • K020764 — NAVIPRO (June 3, 2002)
  • K013982 — KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (May 21, 2002)
  • K010101 — GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (May 17, 2001)
  • K003347 — ORTHOPILOT (February 23, 2001)

Other clearances for product code LPH

  • K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrain (July 10, 2026)
  • K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed C (June 5, 2026)
  • K251270 — Taperloc® Complete Hip Stem (May 19, 2026)
  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)

FDA data resources