Dynasty Acetabular System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K070785 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Profemur Z Classic Stems

  Class II

  FDA 510(k) K123434 Active Cleared 5 Feb 2013

• Cannulated Screw System

  Class II

  FDA 510(k) K143460 Active Cleared 23 Jan 2015

• Small Bone Wedge

  Class II

  FDA 510(k) K070592 Active Cleared 5 Oct 2007

• BIOFOAM Bone Wedge

  Class II

  FDA 510(k) K142724 Active Cleared 20 May 2015

• PROPHECY INVISION Preoperative Navigation Alignment System

  Class II

  FDA 510(k) K162795 Active Cleared 22 Feb 2017

• Salvation Beams and Bolts System

  Class II

  FDA 510(k) K140741 Active Cleared 15 May 2014

See all devices from Wrightmedicaltechnologyinc →

• What types of hip surgeries is the Dynasty Acetabular System designed for, and how does its semi-constrained design benefit patients?

  The Dynasty Acetabular System is specifically designed for total hip arthroplasty procedures where the acetabulum (hip socket) is damaged or diseased and requires replacement. Its semi-constrained metal construction provides stability while allowing some flexibility, which can help reduce dislocation risks compared to fully constrained implants. This design is particularly useful in cases where moderate instability is anticipated, offering a balance between stability and joint mobility.

• Is the Dynasty Acetabular System reusable or single-use, and how should it be handled in the operating room?

  The Dynasty Acetabular System is supplied as a reusable surgical implant, meaning it is intended for multiple uses after proper sterilization and maintenance. However, it must be handled according to sterile surgical protocols due to its metal construction, which makes it MRI-unsafe. This means it should be stored and processed in a way that ensures sterility and integrity for each use, adhering to standard orthopedic implant handling guidelines.

• What range of sizes and variants are available for the Dynasty Acetabular System, and how does this affect its versatility in surgical applications?

  The Dynasty Acetabular System comes in multiple acetabular sizes and variants, as indicated by the listed FEI numbers (e.g., 3020282716, 3007923096, etc.). These variations allow surgeons to select the appropriate component for different patient anatomies and surgical needs, ensuring a better fit and fixation. This versatility is particularly important in orthopedic procedures where precise sizing can impact long-term implant stability and patient outcomes.

• Can the Dynasty Acetabular System be used with MRI imaging, and if not, what precautions should be taken during and after surgery?

  No, the Dynasty Acetabular System is not MRI-safe due to its metal construction. This means MRI imaging should be avoided in patients with this implant, as the metal components can interfere with the MRI scan and pose safety risks. Surgeons and patients should be aware of this limitation and follow guidelines for alternative imaging modalities when necessary, such as X-rays or CT scans.

• What regulatory pathway was followed for the FDA clearance of the Dynasty Acetabular System, and what does this mean for its use in clinical practice?

  The Dynasty Acetabular System received FDA clearance through the 510(k) pathway, specifically with a special advisory committee review (Orthopedic Advisory Committee) and was determined to be substantially equivalent to a predicate device. This means the device met FDA requirements for safety and effectiveness, and its use is authorized for orthopedic surgeries requiring acetabular reconstruction as described in the approved labeling. Clinicians can rely on this clearance as evidence of the device’s regulatory compliance.