510(k) Report

FDA applicant

Flower Orthopedics Corporation

Horsham, PA8 decisions2013–20208 recalls

FDA records 8 decisions for Flower Orthopedics Corporation (Horsham, PA) from 2013 to 2020: 8 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 39 predicates, 10 of them its own earlier devices. 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Flower Orthopedics Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2013: 42014: 22017: 12020: 1
2013high 4 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2021

2015: 12020: 62021: 1
2013high 6 (2020) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Flower Orthopedics Corporation by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone5decisions
  • HWCScrew, Fixation, Bone2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision

Whose devices does it build on?

Its devices cite 39 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 20137cite it
  • K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation · 20134cite it
  • K132248Flower Bone Screw SetFlower Orthopedics Corporation · 20131cites it

What has FDA decided for it lately?

  • K192949Flower Suture Anchor SetFlower Orthopedics Corporation · 2020
  • K170687Flower Bone Screw SetFlower Orthopedics Corporation · 2017
  • K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation · 2014
  • K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation · 20146 recalls
  • K133102Flower Ankle Plating SetFlower Orthopedics Corporation · 2013
  • K132248Flower Bone Screw SetFlower Orthopedics Corporation · 2013
  • K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation · 20131 recall
  • K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 20132 recalls

All 8 as Flower Orthopedics Corporation →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K123562Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201Sep 3, 2021Class II
  • K133930Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage…Jul 8, 2020Class II
  • K133930Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage…Jul 8, 2020Class II
  • K133930Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage…Jul 8, 2020Class II
  • K133930Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage…Jul 8, 2020Class II
  • K133930Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage…Jul 8, 2020Class II

Other applicant names beginning “Flower”

FDA records each applicant name separately; these may or may not be the same firm.

Flower Orthopedics Corporation Dba Conventus Flower 2Flower Orthopedics Corporation Dba Conventus Flower… 1Flower Orthopedics Corporation DBA Conventus Flower… 1