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RM Isoelastic Bevelled Acetabular Cup

by Robert Mathys Co.

510(k) K903116

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 NumberK903116 Date23 Oct 1990ClearedStatusActive

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  • Withdrawn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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The RM Isoelastic Bevelled Acetabular Cup is a monoblock uncemented cup used in total hip replacement. It features a modulus of elasticity approximating bone to better match stresses on the acetabulum and preserve bone structure. The cup is designed as a single-piece implant with a bevelled configuration.

This device is supplied as a single-use implant and requires appropriate storage conditions. It received FDA 510(k) clearance with K903116 on October 23, 1990, and is classified under product code JDI. The cup is available in various sizes as specified by the manufacturer.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the RM Isoelastic Bevelled Acetabular Cup used for?

    It is used as a monoblock uncemented acetabular component in total hip replacement surgery to replace the hip socket, designed to match bone elasticity and reduce stress shielding.

  • How is the RM Isoelastic Bevelled Acetabular Cup supplied and is it reusable?

    It is supplied as a sterile, single-use implant intended for one-time surgical implantation; it is not designed for cleaning, resterilization, or reuse due to material integrity and infection control risks.

  • What sizes are available for the RM Isoelastic Bevelled Acetabular Cup?

    The cup is available in various sizes as specified by the manufacturer, though exact dimensions are not detailed in the provided data; sizing options are determined by Robert Mathys Co. for anatomical fit.