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Sign in to claim this brandFLOWER ORTHOPEDICS CORPORATION
US
Last updated May 24, 2026
What FLOWER ORTHOPEDICS CORPORATION makes
Flower Orthopedics Corporation manufactures orthopaedic fixation hardware, including non-bioabsorbable bone screws (both cannulated and non-sliding), fixation plates for joints like the metatarsophalangeal (MTP) region, and orthodontic anchoring screws. Their portfolio also includes reusable surgical tools such as implant templates and depth limiters, as well as orthopaedic bone wires and headless compression screws for internal fixation. Devices are designed for procedures like fracture stabilization, joint reconstruction, and bone alignment, with variations in thread profiles and screw lengths to accommodate different anatomical needs.
The company’s products are regulated under FDA classification as Class I and Class II devices, with most listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for surgical use in orthopaedic applications and must comply with relevant U.S. regulatory requirements for medical device safety and performance. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Flower Orthopedics Corporation primarily manufacture?
Flower Orthopedics Corporation specializes in orthopaedic fixation devices, including non-bioabsorbable bone screws (such as cannulated and non-sliding varieties), fixation plates for joints like the metatarsophalangeal (MTP) region, and orthodontic anchoring screws. Their portfolio also includes reusable surgical tools like implant templates and depth limiters, as well as orthopaedic bone wires and headless compression screws. These devices are designed for fracture stabilization, joint reconstruction, and bone alignment procedures.
Where is Flower Orthopedics Corporation based?
Flower Orthopedics Corporation is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those governing orthopaedic hardware.
Are Flower Orthopedics Corporation’s devices listed in any regulatory registries?
Yes, many of Flower Orthopedics Corporation’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the orthopaedic fixation market.
How are Flower Orthopedics Corporation’s devices classified under FDA regulations?
Flower Orthopedics Corporation’s devices fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices—such as certain orthopaedic fixation hardware—require stricter controls due to their role in critical surgical procedures. Classification depends on factors like intended use and potential risk to patients.
What kinds of orthopaedic procedures are Flower Orthopedics Corporation’s devices intended for?
Flower Orthopedics Corporation’s devices are designed for orthopaedic procedures including fracture stabilization, joint reconstruction, and bone alignment. Examples include fixation of long bones, joint-specific plates (like MTP plates for the foot), and screws tailored for specific anatomical needs, such as variable-angle compression or headless compression screws for precise internal fixation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- flowerortho.com
- —
- —
- [email protected]
- Phone
- 8777788587
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 078790947
Catalogue (2233)
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FDA Recalls (16)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Flower Orthopedics Corporation has 16 recall records initiated between February 16, 2015, and August 29, 2023. The records include open, classified, and terminated statuses, with reasons involving mechanical failures such as broken cannulated screwdrivers, non-locking pegs, missing or incompatible components (e.g., drill bits without AO connect, missing countersinks, or mismatched inserter parts), and manufacturing errors like incorrect material use in calcaneus plates. Some recalls cite potential delays in surgical procedures or the need for additional interventions due to device malfunctions.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 29, 2023 | Z-0074-2024 | — | open, classified | Device is breaking while in use, potential for patients to require a revision surgery. |
| Nov 2, 2021 | Z-0448-2022 | — | terminated | Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available |
| Sep 3, 2021 | Z-0034-2022 | — | terminated | Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced) |
| Sep 1, 2021 | Z-0113-2022 | — | terminated | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| Sep 1, 2021 | Z-0114-2022 | — | terminated | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| Sep 1, 2021 | Z-0112-2022 | — | terminated | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| Sep 1, 2021 | Z-0111-2022 | — | terminated | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure |
| Apr 15, 2021 | Z-1698-2021 | — | terminated | Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages |
| Jul 8, 2020 | Z-2785-2020 | — | terminated | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Z-2783-2020 | — | terminated | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Z-2784-2020 | — | terminated | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Z-2786-2020 | — | terminated | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Z-2787-2020 | — | terminated | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Z-2782-2020 | — | terminated | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Dec 22, 2016 | Z-1113-2017 | — | terminated | The product is being recalled due to incidence and reports of the product breaking during surgery. |
| Feb 16, 2015 | Z-1314-2015 | — | terminated | Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg. |