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510(k) K892398

BIPOLAR HIP SYSTEM by Orthomet, Inc. — Product Code KXA

K892398 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "BIPOLAR HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on May 23, 1989. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Orthomet, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1989
Date Received
April 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral, Resurfacing
Device Class
Class II
Regulation Number
888.3400
Review Panel
OR
Submission Type

Other clearances by Orthomet, Inc.

  • K936310 — ORTHOMET HMC FEMORAL STEM COMPONENT (June 7, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT (December 28, 1994)
  • K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM (November 30, 1994)
  • K926334 — AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER (October 18, 1994)
  • K932677 — AXIOM TOTAL KNEE SYSTEM (October 14, 1994)
  • K931333 — ORTHOMET ACETABULAR CUP SYSTEM (October 14, 1994)
  • K931678 — ORTHOMET LHMC FEMORAL STEM (October 14, 1994)
  • K925536 — HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (January 7, 1994)

Other clearances for product code KXA

  • K201219 — Biocore9 Femoral Head Resurfacing Component (January 19, 2021)
  • K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD (April 15, 2010)
  • K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT (December 12, 2008)
  • K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (June 29, 2007)
  • K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (April 26, 2007)
  • K062960 — CONSERVE FEMORAL RESURFACING COMPONENT (December 1, 2006)
  • K043542 — BIOPRO TARA FEMORAL RESURFACING COMPONENT (May 18, 2005)
  • K032659 — DEPUY ASR RESURFACING FEMORAL HEADS (December 4, 2003)
  • K023188 — PRESS-FIT HEAD RESURFACING DEVICE (December 11, 2002)
  • K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (August 1, 2002)

FDA data resources