# Trinity Acetabular Hip System 9210034

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/trinity-acetabular-hip-system-9210034>
- Manufacturer: [Corin Ltd](https://devicerts.com/manufacturers/corin-ltd) (FDA registration: United Kingdom)
- Device class: Class I (EU MDD); Class II (US FDA)
- FDA product code: MEH, LZO
- EMDN: L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
- GMDN: Orthopaedic implant impactor, reusable (32856)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-05055343896112 · UDI-DI 05055343896112 · registered 2026-10-14 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 05055343896112 · listed 2019-01-08 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K170359 · decision 2017-10-31 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2608-2021 · Class II · terminated · initiated 2021-07-28: The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

## Identity

- Trade name: Impactor Head (Size 2) [EUDAMED]; Trinity Acetabular Hip System [FDA GUDID (AccessGUDID)]
- Generic name: Orthopaedic implant impactor, reusable [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 9210034 [EUDAMED, FDA GUDID (AccessGUDID)]; Trinity Acetabular System Instrument Set [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 05055343896112 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-05055343896112 [EUDAMED]
- 510(k) Number: K170359 [FDA GUDID (AccessGUDID)]
- FDA product code: MEH [FDA GUDID (AccessGUDID)]; LZO [FDA GUDID (AccessGUDID)]
- EMDN code: L0999 [EUDAMED]
- GMDN term: Orthopaedic implant impactor, reusable (32856) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 888.3353 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Trinity Acetabular Hip System 9210034, Corin Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/trinity-acetabular-hip-system-9210034 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/trinity-acetabular-hip-system-9210034.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/trinity-acetabular-hip-system-9210034
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.