# Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
> **Food and Drug Administration** · Final order. · Published 2016-02-18 · Effective 2016-02-18 · 81 FR 8146
## Document
- **Document number:** 2016-03331
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 8146
- **CFR reference:** 21 CFR 888
- **Publication date:** 2016-02-18
- **Effective date:** 2016-02-18
- **HHS docket:** Docket No. FDA-2011-N-0661
## Abstract

The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/02/18/2016-03331/effective-date-of-requirement-for-premarket-approval-for-total-metal-on-metal-semi-constrained-hip)
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