Skip to content

Proforma/Ps Total Hip System

by Orthomet, Inc.

510(k) K880435

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 NumberK880435 Date29 Jun 1988ClearedStatusActive

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  • Withdrawn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, 19 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 PROFORMA/PS TOTAL HIP SYSTEM is a total hip prosthesis system intended for use in orthopedic applications. It is classified under product code JDI and has been determined to be substantially equivalent to a predicate device.

The system was cleared via the traditional 510(k) pathway by the FDA under K880435, with a decision date of June 29, 1988. It is manufactured by Orthomet, Inc. and is supplied as a non-sterile, reusable device for orthopedic implantation procedures.

Other devices from Orthomet, Inc.

See all devices from Orthomet, Inc. →

Questions

AI-generated answers, 19 Sep 2026

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

  • Is the PROFORMA/PS Total Hip System intended for single-use or can it be reused after implantation?

    The PROFORMA/PS Total Hip System is supplied as a non-sterile, reusable device, meaning it is designed for multiple uses in orthopedic implantation procedures after proper cleaning and sterilization between cases. Reusability is a key feature of this system, allowing for cost-effective use across multiple patients.

  • What type of regulatory clearance does the PROFORMA/PS Total Hip System have, and when was it approved?

    The PROFORMA/PS Total Hip System received FDA clearance via the traditional 510(k) pathway under submission number K880435. The decision date was June 29, 1988, confirming its substantial equivalence to a predicate device in orthopedic applications.

  • How is the PROFORMA/PS Total Hip System packaged and prepared for use in the operating room?

    The system is supplied in a non-sterile form, meaning it requires sterilization before use in orthopedic procedures. Clinicians must follow proper sterilization protocols to ensure safety and compliance with surgical standards before implantation.

  • What orthopedic category does the PROFORMA/PS Total Hip System fall under in regulatory filings?

    The PROFORMA/PS Total Hip System is classified under product code JDI, which corresponds to total hip prostheses in the FDA’s regulatory framework. This classification aligns with its intended use in orthopedic total hip replacement procedures.