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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 2 of 45
DeviceModel / ReferenceRegistriesClassStatus
Opening Wedge Plate, 3.5mm FOW 035
FDA UDI
Class IIActive
Headless Compression Screw, D:2.2mm x L: 12mm HCS 012
FDA UDI
Class IIActive
Variable Angle Locking Screw, Low Profile FLP 220
FDA UDI
Class IIActive
Lag Screw, Fully Threaded LSF 335
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FBS 511
FDA UDI
Class IIActive
Cannulated Countersink 5.5/6.5/7.3 CCS 080
FDA UDI
Class IActive
Calcaneus Plate, MIS, Large, Left CPF 114
FDA UDI
Class IIActive
Headless Compression Screw, D:3.5mm x L: 55mm HCS 355
FDA UDI
Class IIActive
Flower Orthopedics RAD311
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 624
FDA UDI
Class IIActive
Flex-Thread TDS040
FDA UDI
Class IActive
Cannulated Screw, Partially Threaded CSP 125
FDA UDI
Class IIActive
Flex-Thread Ulna FCR 045
FDA UDI
Class IActive
Variable Angle Non-Locking Screw FBS 445
FDA UDI
Class IIActive
Flower Orthopedics FPSC2726
FDA UDI
Class IIActive
Variable Angle Locking Screw FHF 214
FDA UDI
Class IIActive
Flower Orthopedics FPSC3524
FDA UDI
Class IIActive
H&F Straight Plate, 10 Holes, 1.5mm/2.0mm/2.4mm FFP 410
FDA UDI
Class IIActive
Jones Screw, Partially Threaded, D: 5.5mm x L: 75mm FJS 675
FDA UDI
Class IIActive
Flower Orthopedics FPSL3544
FDA UDI
Class IIActive
Flower Orthopedics OC45055
FDA UDI
Class IIActive
Distal Radius Plate, Volar (R), 9 Holes, FRP 452
FDA UDI
Class IIActive
Variable Angle Locking Screw, Low Profile FLP 212
FDA UDI
Class IIActive
Power Driver G-Wire Kit, 3.0-4.5mm Cannulated Screws FIM 015
FDA UDI
Class IActive
Flower Orthopedics FPSL2716
FDA UDI
Class IIActive
Cannulated Screw, Partially Threaded CSP 996
FDA UDI
Class IIActive
Flower Orthopedics OC73055
FDA UDI
Class IIActive
Cannulated Drill Bit, 4.0mm CDB 240
FDA UDI
Class IActive
Cannulated Screw, Partially Threaded CSP 416
FDA UDI
Class IIActive
Flower Orthopedics RAD314
FDA UDI
Class IIActive
Flex-Thread DBS035
FDA UDI
Class IActive
Variable Angle Locking Screw FRP 212
FDA UDI
Class IIActive
Distal Radius Plate, Volar (R), 13 Holes, FRP 456
FDA UDI
Class IIActive
1.75mmTMT Plate, 6 Holes, (L), 2.7mm/3.0mm FFP 004
FDA UDI
Class IIActive
Flower Orthopedics RAD310
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FBS 008
FDA UDI
Class IIActive
Headless Compression Screw, D:6.5mm x L: 75mm HCS 775
FDA UDI
Class IIActive
Lag Screw, Partially Threaded LSP 345
FDA UDI
Class IIActive
Flower Orthopedics FPSL2770
FDA UDI
Class IIActive
Cannulated Screw, Fully Threaded CSF 525
FDA UDI
Class IIActive
Flex-Thread CS2440
FDA UDI
Class IActive
Flex-Thread Ulna FTU 729-S
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 212
FDA UDI
Class IIActive
Headless Compression Screw, D:2.2mm x L: 20mm HCS 020
FDA UDI
Class IIActive
Flower Orthopedics FPSL3526
FDA UDI
Class IIActive
Cannulated Screw, Fully Threaded CSF 425
FDA UDI
Class IIActive
Variable Angle Locking Screw FRP 128
FDA UDI
Class IIActive
Flower Orthopedics FPSC2722
FDA UDI
Class IIActive
Headless Compression Screw, D:3.0mm x L: 14mm HCS 214
FDA UDI
Class IIActive
Jones Screw, Partially Threaded, D: 5.5mm x L: 50mm FJS 650
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.