510(k) · Cleared
ClearedFlower Ankle Plating Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flower Orthopedics Corporation · HRS Plate, Fixation, Bone
Cleared on Nov 18, 2013 as substantially equivalent to K083213 (Synthes (Usa), 2008) and 4 other predicates after a 49-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Nov 18, 2013
- Review
- 49 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K962616 (1996). 122 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- This deviceK133102 Flower Ankle Plating SetFlower Orthopedics Corporation · 2013
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- This deviceK133102 Flower Ankle Plating SetFlower Orthopedics Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −3 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −2 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −1 | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal… | Synthes USA | 2012 | — |
| 0 (this device) | K133102 | Flower Ankle Plating Set | Flower Orthopedics Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 11 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083213 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 1…C.F.R. 888.3040, Smooth or threaded metallic bone fixation fastener: Class 11). Predicate Devices Synthes USA, Synthes 2.7mm/3.Smm LCP Distal Fibula Plates (K083213) Synthes USA, Synthes Variable Angle LCP Ankle Trauma System (K120854) Synthes USA, Synthes 2.7/3.5mm Variable Angl… | 2008 |
| * | K120854 | Synthes VA LCP Ankle Trauma SystemSummary page 1…ss 11). Predicate Devices Synthes USA, Synthes 2.7mm/3.Smm LCP Distal Fibula Plates (K083213) Synthes USA, Synthes Variable Angle LCP Ankle Trauma System (K120854) Synthes USA, Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plates (K121601)… | 2012 |
| * | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSummary page 1…s Variable Angle LCP Ankle Trauma System (K120854) Synthes USA, Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plates (K121601) Flower Orthopedics Corporation, Flower Small and Medium Implants Set (K123562 and K131657) Intended Use I Indicat… | 2012 |
| * | K123562 | Flower Small and Medium Bone ImplantsSummary page 1…mm Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plates (K121601) Flower Orthopedics Corporation, Flower Small and Medium Implants Set (K123562 and K131657) Intended Use I Indications for Use The Flower Ankle Plating Set is intended for use for fixation of… | 2013 |
| * | K131657 | Flower Small and Medium Implant SetSummary page 1…CP Ankle Trauma System-Anterolateral Distal Tibia Plates (K121601) Flower Orthopedics Corporation, Flower Small and Medium Implants Set (K123562 and K131657) Intended Use I Indications for Use The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 30 of the 122 ancestors have a recall of any class.
- 8 other devices also cite its predicate K083213.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically, * Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, * Distal Tibia A-Plates are…
Read the full statement (117 words)
The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically,
* Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
* Distal Tibia A-Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
* Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133102: Flower Ankle Plating Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133102
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026