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FLOWER 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
—
LinkedIn
—
Facebook
—
Phone
8777788587
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
078790947

Catalogue (2233)

Page 5 of 45
DeviceModel / ReferenceRegistriesClassStatus
Flower Orthopedics ULN304
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FBS 120
FDA UDI
Class IIActive
Evans Plate, 4 Hole, 16mm Wide AGB 316
FDA UDI
Class IIActive
Flex-Thread DBS028
FDA UDI
Class IActive
1.5mm H&F T-Plate, 7 Holes, 1.5mm/2.0mm/2.4mm FHF 445
FDA UDI
Class IIActive
Flower Orthopedics FPSC2762
FDA UDI
Class IIActive
Flower Orthopedics OC65105
FDA UDI
Class IIActive
ZERO Profile Interlocking Cortex Screw, 3.5mm x 65mm, T15, Flex-Thread™ 8525-65-S
FDA UDI
Class IIActive
Lag Screw, Partially Threaded LSP 130
FDA UDI
Class IIActive
Opening Wedge Plate, 5.5mm FOW 055
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 328
FDA UDI
Class IIActive
Distal Radius Plate, Volar (R), 11 Holes FRP 454
FDA UDI
Class IIActive
Jones Screw, Short Threaded, D: 5.5mm x L:70mm FJS 270
FDA UDI
Class IIActive
Lag Screw, Partially Threaded LSP 250
FDA UDI
Class IIActive
Flower Orthopedics FPSC2758
FDA UDI
Class IIActive
Variable Angle Locking Screw FRP 120
FDA UDI
Class IIActive
Distal Radius Plate, Standard, Left, 3 Holes FDR 011
FDA UDI
Class IIActive
Cannulated Screw, Partially Threaded CSP 660
FDA UDI
Class IIActive
Flower Orthopedics OC73105
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FBS 012
FDA UDI
Class IIActive
ZERO Profile Interlocking Cortex Screw, 3.5mm x 54mm, T15, Flex-Thread™ 8525-54-S
FDA UDI
Class IIActive
Jones Screw, Partially Threaded, D: 5.5mm x L: 40mm FJS 640
FDA UDI
Class IIActive
Flower Orthopedics RAD312
FDA UDI
Class IIActive
Flower Orthopedics FPSC4062
FDA UDI
Class IIActive
Guide Wires, 2.0mm x 220mm GWK 122
FDA UDI
Class IActive
T-Plate Trials FIS 603
FDA UDI
Class IActive
Distal Clavicle Plate, Left, 10 Holes FCP 310
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 536
FDA UDI
Class IIActive
Cannulated Screw, Partially Threaded CSP 745
FDA UDI
Class IIActive
Recon Plate Trials, 2.0mm FIS 900
FDA UDI
Class IActive
Cannulated Screw, Fully Threaded CSF 720
FDA UDI
Class IIActive
Lag Screw, Partially Threaded LSP 240
FDA UDI
Class IIActive
Variable Angle Locking Screw, Low Profile FLP 230
FDA UDI
Class IIActive
Flower Orthopedics OC65085
FDA UDI
Class IIActive
Cortex Screw, 3.5mm x 65mm, T15, Flex-Thread™ 8428-65-S
FDA UDI
Class IIActive
Cannulated Drill Kit, 1.7mm CDK 017
FDA UDI
Class IActive
Cannulated Screw, Partially Threaded CSP 725
FDA UDI
Class IIActive
Variable Angle Compression Screw D:1.5 x L: 12mm FCS 112
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 430
FDA UDI
Class IIActive
Lag Screw, Fully Threaded LSF 015
FDA UDI
Class IIActive
Variable Angle Locking Screw FHF 026
FDA UDI
Class IIActive
Headless Compression Screw, D:3.0mm x L: 12mm HCS 212
FDA UDI
Class IIActive
Recon Plate, 6 Holes FRP 906
FDA UDI
Class IIActive
Flower E-Kit EWK 200
FDA UDI
Class IIActive
2.0mm Recon T-Plate, 5 Holes, 1.5mm/2.0mm/2.4mm FHF 925
FDA UDI
Class IIActive
Flower Orthopedics XUPT304
FDA UDI
Class IActive
Flower Orthopedics FPSC3518
FDA UDI
Class IIActive
Proximal Humerus Plate, 12 Holes, FRP 465
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FBS 260
FDA UDI
Class IIActive
Jones Screw, Partially Threaded, D: 4.5mm x L: 70 FJS 570
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Aug 29, 2023Z-0074-2024—open, classified

Device is breaking while in use, potential for patients to require a revision surgery.

Nov 2, 2021Z-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, 2021Z-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, 2021Z-0113-2022—terminated

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Sep 1, 2021Z-0114-2022—terminated

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Sep 1, 2021Z-0112-2022—terminated

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Sep 1, 2021Z-0111-2022—terminated

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Apr 15, 2021Z-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, 2020Z-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, 2020Z-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, 2020Z-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, 2020Z-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, 2020Z-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, 2020Z-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, 2016Z-1113-2017—terminated

The product is being recalled due to incidence and reports of the product breaking during surgery.

Feb 16, 2015Z-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.