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Zimmer MMC Cup

by Zimmer GmbH

510(k) K091003

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091003 Date24 Nov 2009ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KWA
Device class
Class III
Regulation
21 CFR Part 888.3330
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Zimmer MMC Cup is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). It is designed as an uncemented acetabular cup for use in total hip arthroplasty, providing a semi-constrained interface between the femoral head and acetabular component to enhance stability and range of motion.

This device is intended for surgical implantation by orthopedic specialists in a hospital or clinical setting. Supplied sterile, it is classified as a Class III medical device under FDA regulations (888.3330) and was cleared via a Traditional 510(k) pathway. Multiple sizes and variants are available, as indicated by the listed FEI numbers, and it is intended for single-use per the regulatory submission.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients is the Zimmer MMC Cup designed for, and how does its semi-constrained design benefit them?

    The Zimmer MMC Cup is designed for patients undergoing total hip arthroplasty who require an uncemented acetabular component. Its semi-constrained interface between the femoral head and acetabular cup enhances stability and improves range of motion, which can be particularly beneficial for patients with moderate instability or those needing greater joint flexibility post-surgery. This design is intended for surgical use by orthopedic specialists in controlled settings like hospitals or clinics.

  • How is the Zimmer MMC Cup supplied, and what does this mean for surgical planning?

    The Zimmer MMC Cup is supplied sterile, ensuring it is ready for immediate use in the operating room without additional sterilization steps. This is critical for maintaining aseptic conditions during surgery. Since it is intended for single-use, each package is designed for one surgical procedure, which helps streamline inventory management and reduce the risk of cross-contamination.

  • What size options are available for the Zimmer MMC Cup, and how might this affect my selection?

    The Zimmer MMC Cup comes in multiple sizes, as indicated by the listed FEI numbers (e.g., 3020282716, 3007923096, etc.). These variations allow surgeons to select the appropriate size based on the patient’s anatomy and specific clinical needs. The availability of numerous sizes ensures a better fit for a broader range of patients, which can improve implant stability and long-term outcomes.

  • Is the Zimmer MMC Cup reusable, or is it meant for single-use only? How does this impact storage and inventory?

    The Zimmer MMC Cup is explicitly intended for single-use per the regulatory submission. This means each package is designed for one surgical procedure only, which helps minimize the risk of infection and ensures consistent performance. Clinically, this simplifies inventory management by reducing the need for reprocessing and storage of reusable components, while also aligning with best practices for orthopedic implants.