FLOWER SMALL AND MEDIUM IMPLANT SET— 510(k) K131657

Name: FDA 510(k) clearance K131657
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Substantially Equivalent

Flower Orthopedics Corporation

FDA 510(k) clearance K131657 for FLOWER SMALL AND MEDIUM IMPLANT SET, Substantially Equivalent on 2013-08-22. Applicant: Flower Orthopedics Corporation. Device class: 2.

Clearance details

Applicant: Flower Orthopedics Corporation
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2013-06-06
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Philedelphia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Flower Orthopedics Corporation

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K192949 — Flower Suture Anchor Set2020-10-07
K170687 — Flower Bone Screw Set2017-06-06
K142306 — Flower Upper Extremity Plating Set2014-09-15
K133930 — FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET2014-03-27
K133102 — FLOWER ANKLE PLATING SET2013-11-18

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K131657

K-number listed on FDA's recall record

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.Class II·Terminated·Flower Orthopedics Corporation·20150216

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131657.

Data sourced from openFDA. This site is unofficial and independent of the FDA.