Total Hip, Lord Madreporic

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

510(k) Number

K780330 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

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  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What types of orthopedic procedures is the Lord Madreporic Total Hip designed for, and how does its uncemented design benefit patients?

  The Lord Madreporic Total Hip is specifically designed for total hip arthroplasty procedures, where it serves as a semi-constrained metal acetabular component. Its uncemented design allows for direct fixation to the pelvis without the use of bone cement, which can reduce risks associated with cement-related complications like loosening or inflammation. This approach may also promote better bone integration over time, potentially improving long-term stability and durability.

• Is the Lord Madreporic Total Hip reusable or single-use, and what does that mean for surgical planning?

  The Lord Madreporic Total Hip is explicitly described as a reusable surgical implant. This means it is intended to be sterilized and reused for multiple procedures, which can help control costs and reduce waste. However, surgical planning must account for proper sterilization protocols to ensure patient safety between uses, as well as inventory management to maintain availability for procedures.

• Are there multiple sizes or models available for the Lord Madreporic Total Hip, and how might a clinician determine the appropriate fit for a patient?

  The data references multiple FEI numbers (e.g., 3020282716), which typically correspond to different variants or sizes of the device. While specific measurements or sizing details are not provided, these variants likely cater to different patient anatomies or surgical needs. Clinicians would typically rely on preoperative imaging and sizing guides provided by the manufacturer to select the appropriate acetabular component for a patient’s unique pelvic structure.

• What regulatory pathway was followed for the Lord Madreporic Total Hip, and what does that mean for its use in clinical practice?

  The Lord Madreporic Total Hip was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process, and is classified as a Class III medical device. This classification indicates it carries higher regulatory scrutiny due to its role in supporting life-sustaining or life-sustaining procedures. The clearance (K780330) confirms it was deemed substantially equivalent to a legally marketed predicate device at the time of submission, ensuring it meets FDA standards for safety and effectiveness in total hip arthroplasty procedures.