# Variable Angle Locking Screw FRP 324

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

- Canonical page: <https://devicerts.com/devices/variable-angle-locking-screw-frp-324>
- Manufacturer: [Flower Orthopedics Corporation](https://devicerts.com/manufacturers/flower-orthopedics-corporation) (United States, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: HWC, HRS
- GMDN: Orthopaedic bone screw, non-bioabsorbable, sterile (46646)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00840118100861 · listed 2015-09-15 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K123562 · decision 2013-03-29 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0034-2022 · Class II · terminated · initiated 2021-09-03 · matched through shared submission K123562, may concern other models: Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
- Z-1314-2015 · Class II · terminated · initiated 2015-02-16: Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.

## Identity

- Trade name: Variable Angle Locking Screw [FDA GUDID (AccessGUDID)]
- Generic name: Orthopaedic bone screw, non-bioabsorbable, sterile [FDA GUDID (AccessGUDID)]
- Model / reference: FRP 324 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00840118100861 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K123562 [FDA GUDID (AccessGUDID)]
- FDA product code: HWC [FDA GUDID (AccessGUDID)]
- GMDN term: Orthopaedic bone screw, non-bioabsorbable, sterile (46646) [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: Length — 24 Millimeter [FDA GUDID (AccessGUDID)]; Outer Diameter — 3.5 Millimeter [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Single use: 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)]
- Implantable: 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: Variable Angle Locking Screw FRP 324, Flower Orthopedics Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/variable-angle-locking-screw-frp-324 (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/variable-angle-locking-screw-frp-324.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/variable-angle-locking-screw-frp-324
- 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.