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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 1 of 45
DeviceModel / ReferenceRegistriesClassStatus
Variable Angle Compression Screw FCS 630
FDA UDI
Class IIActive
MTP Plate, Left MFP 401
FDA UDI
Class IIActive
Flower Orthopedics XRPT306
FDA UDI
Class IActive
Variable Angle Locking Screw, Low Profile FLP 232
FDA UDI
Class IIActive
Cannulated Screw, Fully Threaded CSF 020
FDA UDI
Class IIActive
Headless Compression Screw 5.0mm x 40mm HCS 540
FDA UDI
Class IIActive
ZERO Profile Interlocking Cortex Screw, 3.5mm x 36mm, T15, Flex-Thread™ 8525-36-S
FDA UDI
Class IIActive
Lag Screw, Fully Threaded LSF 025
FDA UDI
Class IIActive
Cannulated Screw, Fully Threaded CSF 775
FDA UDI
Class IIActive
MTP Plate, Revision, Graft Hole, Right MFP 632
FDA UDI
Class IIActive
Cortex Screw, 3.5mm x 42mm, T15, Flex-Thread™ 8428-42-S
FDA UDI
Class IIActive
Midshaft Clavicle Plate, Right, 6 Holes FCP 206
FDA UDI
Class IIActive
Variable Angle Locking Screw FHF 106
FDA UDI
Class IIActive
Flower Orthopedics ULN309
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 426
FDA UDI
Class IIActive
Lag Screw, Fully Threaded LSF 540
FDA UDI
Class IIActive
Variable Angle Locking Screw, Low Profile FLP 265
FDA UDI
Class IIActive
Jones Screw, Short Threaded, D: 4.5mm x L: 35mm FJS 135
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FLS 318
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FBS 230
FDA UDI
Class IIActive
Headless Compression Screw, D:6.5mm x L: 80mm HCS 780
FDA UDI
Class IIActive
Flower Orthopedics FPSC4068
FDA UDI
Class IIActive
Flower Orthopedics FPSC3516
FDA UDI
Class IIActive
Lag Screw, Fully Threaded LSF 245
FDA UDI
Class IIActive
Flower Orthopedics OLE007
FDA UDI
Class IIActive
Variable Angle Locking Screw FRP 136
FDA UDI
Class IIActive
Variable Angle Non-Locking Screw FBS 234
FDA UDI
Class IIActive
Locking Screw, XL, D: 2.4mm x L: 20mm FRS 920
FDA UDI
Class IIActive
Humerus Plate Trials FIM 460
FDA UDI
Class IActive
Straight Osteo Plate, 6 Holes, FRP 532
FDA UDI
Class IIActive
Variable Angle Locking Screw FHF 210
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 316
FDA UDI
Class IIActive
Flower Orthopedics FPSC2746
FDA UDI
Class IIActive
Locking Screw, XL, D: 2.4mm x L:12mm FRS 912
FDA UDI
Class IIActive
Flower Orthopedics FPSL4014
FDA UDI
Class IIActive
Distal Clavicle Plate, Right, 6 Holes FCP 406
FDA UDI
Class IIActive
Flower E-Kit, Medium Advanced EWK 202
FDA UDI
Class IActive
Jones Screw, Short Threaded, D: 5.5mm x L:75mm FJS 275
FDA UDI
Class IIActive
Straight Plate with Slots Trials FIS 610
FDA UDI
Class IActive
Flower Orthopedics RAD308
FDA UDI
Class IIActive
Cannulated Screw, Partially Threaded CNP 455
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 326
FDA UDI
Class IIActive
Headless Compression Screw 5.0mm x 32mm HCS 532
FDA UDI
Class IIActive
Cannulated Screw, Partially Threaded CSP 014
FDA UDI
Class IIActive
Variable Angle Compression Screw FCS 620
FDA UDI
Class IIActive
Flower Orthopedics XUPT317
FDA UDI
Class IActive
Medial Distal Tibial Plate Trials FIS 650
FDA UDI
Class IActive
Flower Orthopedics FPSC3534
FDA UDI
Class IIActive
Straight Osteo Plate, 4 Holes FRP 520
FDA UDI
Class IIActive
Mediocarpal Plate Trials, 1.5mm FIS 013
FDA UDI
Class IActive

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.