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510(k) K952731

TOWNLEY ALL POLY ACETABULAR CUP by Biologically Oriented Prostheses — Product Code JDI

K952731 is an FDA 510(k) premarket notification submitted by Biologically Oriented Prostheses for the device "TOWNLEY ALL POLY ACETABULAR CUP". The FDA issued a decision of Substantially Equivalent on December 28, 1995. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Biologically Oriented Prostheses has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
June 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Biologically Oriented Prostheses

  • K002325 — WUJIN #3 TIBIAL NAIL (October 30, 2000)
  • K992144 — BIOPRO RIMMED ACETABULAR COMPOMENT (September 22, 1999)
  • K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT (February 3, 1997)
  • K962769 — HORIZON HIP SYSTEM (October 3, 1996)
  • K955916 — TOWNLEY TOTAL ELBOW SYSTEM (August 8, 1996)
  • K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (January 18, 1996)
  • K953045 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (September 27, 1995)
  • K951356 — VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED (June 19, 1995)

Other clearances for product code JDI

  • K253515 — Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments (August 24, 2026)
  • K253434 — OSSTM Orthopedic Salvage System (July 1, 2026)
  • K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (March 12, 2026)
  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)

FDA data resources