FLOWER ORTHOPEDICS Corporation dba Conventus Flower
Horsham, PA, US
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower appears in FDA device records in Horsham, PA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to FLOWER ORTHOPEDICS Corporation dba Conventus Flower carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Flower Orthopedics Corporation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for FLOWER ORTHOPEDICS Corporation dba Conventus Flower between 2013 and 2022. The busiest year on record is 2013, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 4 |
| 2014 | 2 |
| 2017 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222390 | Flex-Thread™ Ulna Intramedullary Nail System | HSB | Substantially Equivalent | |
| K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | HSB | Substantially Equivalent | |
| K192949 | Flower Suture Anchor Set | MBI | Substantially Equivalent | |
| K170687 | Flower Bone Screw Set | HWC | Substantially Equivalent | |
| K142306 | Flower Upper Extremity Plating Set | HRS | Substantially Equivalent | |
| K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET | HRS | Substantially Equivalent | |
| K133102 | FLOWER ANKLE PLATING SET | HRS | Substantially Equivalent | |
| K132248 | FLOWER BONE SCREW SET | HWC | Substantially Equivalent | |
| K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET | HRS | Substantially Equivalent | |
| K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009996260 | 3009996260 | FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower | 100 Witmer Rd Ste 280, Horsham, PA 19044 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HXWBender
- HTWBit, Drill
- HXDClamp
- HWWCountersink
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTJGauge, Depth
- KDDKit, Surgical Instrument, Disposable
- LXHOrthopedic Manual Surgical Instrument
- HXIPasser, Wire, Orthopedic
- HRSPlate, Fixation, Bone
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0074-2024 | 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 use. Catalogue Number: 8528-1-S | Device is breaking while in use, potential for patients to require a revision surgery. | Class II | Open, Classified | |
| Z-0448-2022 | 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: 8435-1 | 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 | Class II | Terminated | |
| Z-0034-2022 | 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) | Class II | Terminated | |
| Z-0114-2022 | Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027 | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Class II | Terminated | |
| Z-0113-2022 | Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027 | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Class II | Terminated | |
| Z-0112-2022 | Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024 | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Class II | Terminated | |
| Z-0111-2022 | 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. mechanism. Catalog Number: DBK 020 2013002721 | Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure | Class II | Terminated | |
| Z-1698-2021 | 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 Product Code: GWK 300 | 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 | Class II | Terminated | |
| Z-2787-2020 | Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - 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). | Class II | Terminated | |
| Z-2786-2020 | Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - 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). | Class II | Terminated | |
| Z-2785-2020 | Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - 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). | Class II | Terminated | |
| Z-2784-2020 | Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - 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). | Class II | Terminated | |
| Z-2783-2020 | Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - 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). | Class II | Terminated | |
| Z-2782-2020 | 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). | Class II | Terminated | |
| Z-1113-2017 | 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. | Class II | Terminated | |
| Z-1314-2015 | 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, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone. | Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets FLOWER ORTHOPEDICS Corporation dba Conventus Flower edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain