Data / Medical devices / United States / FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower: FDA-registered device maker in Horsham, PA, United States, 11 510(k) clearances
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower is registered with the FDA (registration 3009996260) in Horsham, PA, United States. It lists 18 device types. The FDA files 11 510(k) clearances under its listings, the newest dated November 22, 2024. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009996260
- Address
- 100 Witmer Rd Ste 280, Horsham, PA, United States, 19044
- Owner or operator
- FLOWER ORTHOPEDICS CORPORATION (10044024)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 28, 2013
- Registered through
- 2026
- Brand names listed
- Flex-Thread Distal Fibula Intramedullary Nail System (5.5mm Nail & 1mm End Cap)
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 22, 2024 | K233567 | OsteoCoil Nitinol Compression System (Multiple Component PNs) | HWC | Substantially Equivalent | Flower Orthopedics Corporation Dba Conventus Flower Ortho | accessdata.fda.gov |
| November 21, 2022 | K222390 | Flex-Thread Ulna Intramedullary Nail System | HSB | Substantially Equivalent | Flower Orthopedics Corporation Dba Conventus Flower | accessdata.fda.gov |
| July 23, 2021 | K212030 | Flex-Thread Distal Fibula lntramedullary Nail System | HSB | Substantially Equivalent | Flower Orthopedics Corporation Dba Conventus Flower | accessdata.fda.gov |
| January 22, 2021 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | HSB | Substantially Equivalent | Conventus Orthopaedics, LLC | accessdata.fda.gov |
| July 26, 2019 | K191817 | ActivOrtho Continuous Compression Screw System | HWC | Substantially Equivalent | Activortho, Inc. | accessdata.fda.gov |
| June 6, 2017 | K170687 | Flower Bone Screw Set | HWC | Substantially Equivalent | Flower Orthopedics Corporation | accessdata.fda.gov |
| March 27, 2014 | K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET | HRS | Substantially Equivalent | Flower Orthopedics Corporation | accessdata.fda.gov |
| November 18, 2013 | K133102 | FLOWER ANKLE PLATING SET | HRS | Substantially Equivalent | Flower Orthopedics Corporation | accessdata.fda.gov |
| October 30, 2013 | K132248 | FLOWER BONE SCREW SET | HWC | Substantially Equivalent | Flower Orthopedics Corporation | accessdata.fda.gov |
| August 22, 2013 | K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET | HRS | Substantially Equivalent | Flower Orthopedics Corporation | accessdata.fda.gov |
| March 29, 2013 | K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS | HRS | Substantially Equivalent | Flower Orthopedics Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 29, 2023 | 93024 | Class II | Ongoing | Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single | Device is breaking while in use, potential for patients to require a revision surgery. | accessdata.fda.gov |
| November 2, 2021 | 89092 | Class II | Terminated | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 84 | 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 | accessdata.fda.gov |
| September 3, 2021 | 88724 | Class II | Terminated | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 | Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced) | accessdata.fda.gov |
| September 1, 2021 | 88669 | Class II | Terminated | Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mech | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | accessdata.fda.gov |
| April 15, 2021 | 87906 | Class II | Terminated | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm | 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 | accessdata.fda.gov |
| July 8, 2020 | 86023 | Class II | Terminated | Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). | accessdata.fda.gov |
| December 22, 2016 | 76156 | Class II | Terminated | Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. | The product is being recalled due to incidence and reports of the product breaking during surgery. | accessdata.fda.gov |
| February 16, 2015 | 70578 | Class II | Terminated | Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, | Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg. | accessdata.fda.gov |
Compare with other makers
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Updated November 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.