# Ibs™ S65 ST265

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

- Canonical page: <https://devicerts.com/devices/ibs-s65-st265>
- Manufacturer: [IN2BONES](https://devicerts.com/manufacturers/in2bones) (FDA registration: United States)
- Name in the registry: IBS™ S65 ST265
- Device class: Class II (US FDA)
- FDA product code: HWC
- GMDN: Orthopaedic bone screw (non-sliding) (66947)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 03760225711262 · listed 2015-08-28 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K131920 · decision 2014-05-01 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1319-2024 · Class II · ongoing · initiated 2024-01-26: This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
- Z-1320-2024 · Class II · ongoing · initiated 2024-01-26: This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
- Z-0397-2016 · Class II · terminated · initiated 2015-11-18: One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

## Identity

- Trade name: IBS™ [FDA GUDID (AccessGUDID)]
- Generic name: Orthopaedic bone screw (non-sliding) [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: S65 ST265 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 03760225711262 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K131920 [FDA GUDID (AccessGUDID)]
- FDA product code: HWC [FDA GUDID (AccessGUDID)]
- GMDN term: Orthopaedic bone screw (non-sliding) (66947) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 888.3040 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Outer Diameter — 6.5 Millimeter [FDA GUDID (AccessGUDID)]; Length — 65 Millimeter [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Ibs™ S65 ST265, IN2BONES. deviCERTS medical device catalogue. https://devicerts.com/devices/ibs-s65-st265 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [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/ibs-s65-st265.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/ibs-s65-st265
- 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.