Modified Anatomic Porous Replacement APR Acetabula

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K850793 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Drg Cemeted Stem

  Class II

  FDA 510(k) K920003 Active Cleared 13 Mar 1992

• Intermedics Power Broach Impactor

  Class I

  FDA 510(k) K895121 Active Cleared 11 Sep 1989

• Intermedics High Tibial Osteotomy System

  Class II

  FDA 510(k) K892228 Active Cleared 6 Oct 1989

• Ioi Bipolar Prosthesis

  Class II

  FDA 510(k) K873815 Active Cleared 28 Oct 1987

• Select(R) Shoulder All Poly Glenoid

  Class II

  FDA 510(k) K935802 Active Cleared 22 May 1995

• Zweymueller Sl Femoral Hip Stem

  Class II

  FDA 510(k) K962101 Active Cleared 19 Aug 1996

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• What types of hip surgeries is this acetabular component designed for, and how is it secured in place?

  This device is designed for orthopedic surgical procedures where the acetabular portion of the hip joint needs replacement. It is a semi-constrained metal acetabular component that is secured in place using bone cement, which bonds the implant to the surrounding bone. The porous surface of the component also promotes osseointegration, helping it integrate with the natural bone over time.

• Is this device intended for reuse, or is it meant to be used only once?

  The Modified Anatomic Porous Replacement APR Acetabula is explicitly intended for single-use implantation only. It is supplied sterile and should not be reused after a single surgical procedure to maintain sterility and safety standards.

• How should this device be stored to ensure its sterility and integrity?

  Since this device is supplied sterile, it must be stored and handled according to sterile surgical instrument protocols. This includes keeping it in its original packaging, protecting it from contamination, and following manufacturer guidelines to prevent damage or compromise of sterility before use.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  This device was granted FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class III medical device under FDA regulations (product code JDL), which requires stringent oversight due to its role in replacing a critical joint component.

• Are there multiple sizes or models available for this acetabular component?

  While the provided data does not list specific size or model variations explicitly, the Modified Anatomic Porous Replacement APR Acetabula is designed as a two-part implant with a porous surface to accommodate different anatomical needs. For exact sizing options, refer to the manufacturer’s catalog or technical documentation, as these details are typically tailored to surgical planning and patient anatomy.