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510(k) K971020

LSF TRIAD TOTAL HIP SYSTEM by Osteoimplant Technology, Inc. — Product Code LPH

K971020 is an FDA 510(k) premarket notification submitted by Osteoimplant Technology, Inc. for the device "LSF TRIAD TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on June 18, 1997. 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. Osteoimplant Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1997
Date Received
March 20, 1997
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 Osteoimplant Technology, Inc.

  • K040685 — Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (January 25, 2005)
  • K041443 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (November 16, 2004)
  • K040225 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (May 6, 2004)
  • K032729 — Z-SERIES MODULAR TOTAL HIP SYSTEM (December 3, 2003)
  • K030608 — OTI BONE CEMENT PLUG (June 12, 2003)
  • K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER (November 20, 2002)
  • K021822 — R120 MODULAR TOTAL HIP SYSTEM (July 23, 2002)
  • K012762 — MJS POSTERIOR STABILIZED KNEE SYSTEM (December 11, 2001)
  • K011774 — R120 MODULAR TOTAL HIP SYSTEM (September 5, 2001)
  • K003316 — OTI CERAMIC FEMORAL HEAD SYSTEM (January 19, 2001)

Other clearances for product code LPH

  • K253630 — Mpact 3D Metal Foam (August 28, 2026)
  • K254043 — TRIVANCE™ Hip Stem (August 4, 2026)
  • 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)

FDA data resources