Inter-Op Metasul Acetabular System

• • Terminated Z-1136-2015 FDA Class II ·initiated 17 Dec 2014

  Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

510(k) Number

K974728 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Natural-Hip Cocr Offset Stem

  Class II

  FDA 510(k) K973681 Active Cleared 19 Dec 1997

• Sulzer Orthopedics Converge Acetabular System

  Class II

  FDA 510(k) K012961 Active Cleared 18 Oct 2001

• Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

  Class II

  FDA 510(k) K983153 Active Cleared 4 Dec 1998

• Natural-Hip Porous Stem with Offset

  Class II

  FDA 510(k) K973675 Active Cleared 19 Dec 1997

• Allofit Acetabular System 32mm Alpha Durasul Inserts

  Class II

  FDA 510(k) K013935 Active Cleared 13 Dec 2001

• Magna-Rom 21 Knee Systeem

  Class II

  FDA 510(k) K991143 Active Cleared 11 Jun 1999

See all devices from Sulzer Orthopedics, Inc. →

• What types of hip surgeries is the Inter-Op Metasul Acetabular System designed for, and why is it considered semi-constrained?

  The Inter-Op Metasul Acetabular System is designed for hip replacement surgeries where the natural hip joint requires replacement, providing structural support and articulation. It is classified as semi-constrained, meaning it offers moderate stability to the hip joint while allowing some flexibility, which helps balance mobility and stability during recovery. This design is particularly useful in cases where a fully constrained system might be too rigid, but additional stability is needed compared to a fully unconstrained cup.

• How many sizes are available for the Inter-Op Metasul Acetabular System, and how are they identified?

  The Inter-Op Metasul Acetabular System comes in multiple sizes, each identified by a unique FEI (Federal Equipment Identifier) number. Over 50 distinct FEI numbers are listed, ensuring a wide range of acetabular component sizes to accommodate different patient anatomies and surgical needs. These sizes allow for precise customization during hip replacement procedures.

• Is the Inter-Op Metasul Acetabular System intended for single-use or can it be reused in multiple surgeries?

  The Inter-Op Metasul Acetabular System is explicitly described as a reusable surgical implant. It is intended for use in orthopedic procedures under sterile conditions, meaning it must be properly cleaned, sterilized, and prepared for each surgical case to ensure patient safety and compliance with medical standards.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?

  The Inter-Op Metasul Acetabular System was cleared through the FDA 510(k) process, specifically under a Traditional 510(k) route, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and performance. Clinicians can rely on this clearance when selecting it for hip replacement surgeries.

• How should the Inter-Op Metasul Acetabular System be stored, and what considerations should be taken into account?

  Since the device is reusable and intended for sterile use, it must be stored in a clean, controlled environment to prevent contamination. While the data does not specify exact storage conditions, standard orthopedic implant protocols—such as dry storage in sealed packaging, protection from moisture, and adherence to manufacturer guidelines—should be followed. Proper handling ensures longevity and sterility before surgical use.