Duraloc 300S Acetabular Cup with Porocoat

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Duraloc(Tm) 300S Acetabular Cup with Porocoat(Tm)

Generic Name

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

PMA Number

P880025 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Delta Shoulder

  Class II

  FDA 510(k) K021478 Active Cleared 18 Nov 2003

• Synatomic Revision Femoral Prosthesis

  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

  Class II

  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

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  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

  Class II

  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →

• What type of hip replacement procedure is the Duraloc 300S Acetabular Cup designed for, and how does its design support bone integration?

  The Duraloc 300S Acetabular Cup is designed for total hip arthroplasty procedures where a semi-constrained metal/polymer hip prosthesis is required. Its porous-coated surface enables uncemented fixation, allowing it to integrate with surrounding bone tissue through a process called osseointegration. The porous structure promotes bone ingrowth, providing long-term stability without the need for bone cement.

• Is the Duraloc 300S Acetabular Cup intended for single-use or can it be reused in multiple surgeries?

  The device is explicitly labeled as a reusable surgical implant, meaning it is intended for use in multiple procedures after proper cleaning, sterilization, and maintenance. This distinguishes it from single-use implants, which are discarded after one application.

• What regulatory pathway does the Duraloc 300S Acetabular Cup follow in the U.S., and what does that mean for its approval status?

  The device follows the FDA Premarket Approval (PMA) pathway, indicated by PMA number P880025. This means it underwent a rigorous review process to demonstrate safety and effectiveness before commercialization. The supplement (S001) under a normal 180-day review track indicates updates to its design, components, or specifications were also evaluated by the FDA.

• How is the Duraloc 300S Acetabular Cup supplied, and what does its semi-constrained design imply for surgical flexibility?

  The device is supplied as a reusable implant for orthopedic use, though specific packaging details (e.g., sterilization method or packaging type) are not provided. The semi-constrained design allows for some rotational movement while maintaining stability, which can be advantageous in surgeries requiring moderate joint motion control—such as in cases of moderate acetabular bone loss or instability.