510(k) · Cleared
Recalled · Class II · 2020Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot 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 Mar 27, 2014 as substantially equivalent to K991407 (Synthes (Usa), 1999) and 5 other predicates after a 94-day review. Its family tree reaches back 12 generations to 2001. It has been recalled 6 times.
- Decided
- Mar 27, 2014
- Review
- 94 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 6
- Predicates
- 6
Its longest line of descent runs back 12 generations to K010612 (2001). 128 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 8 generations between
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 1 generation backK120667 VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM…Smith & Nephew, Inc. · 2012
- This deviceK133930 Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower…Flower Orthopedics Corporation · 2014
Show all 12 generations
- Root · 12 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 11 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 10 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 9 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 8 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 7 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 6 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 5 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 4 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 3 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 2 generations backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- 1 generation backK120667 VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM…Smith & Nephew, Inc. · 2012
- This deviceK133930 Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower…Flower Orthopedics Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −11 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −10 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −9 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −8 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −7 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −6 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −5 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −4 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −2 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| −1 | K120667 | VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior… | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K133930 | Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot… | Flower Orthopedics Corporation | 2014 | — |
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 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 1 | 0 |
| 1998 | 8 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 14 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 1…ct code HWC (21 C.F.R. 888.3040, Smooth or threaded metallic bone fixation fastener; Class 1I). Predicate Devices Synthes USA, Locking Calcaneal Plates (K991407) Smith & Nephew, VLP Foot Plating System (K1 10670, K090675) Smith & Nephew, Peri-Loc Ankle Fusion Plating System (… | 1999 |
| * | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Summary page 1…d metallic bone fixation fastener; Class 1I). Predicate Devices Synthes USA, Locking Calcaneal Plates (K991407) Smith & Nephew, VLP Foot Plating System (K1 10670, K090675) Smith & Nephew, Peri-Loc Ankle Fusion Plating System (K120667) Flower Orthopedics, Small and Medium Impla… | 2011 |
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 1…bone fixation fastener; Class 1I). Predicate Devices Synthes USA, Locking Calcaneal Plates (K991407) Smith & Nephew, VLP Foot Plating System (K1 10670, K090675) Smith & Nephew, Peri-Loc Ankle Fusion Plating System (K120667) Flower Orthopedics, Small and Medium Implant Set (K… | 2009 |
| * | K120667 | VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Summary page 1…s USA, Locking Calcaneal Plates (K991407) Smith & Nephew, VLP Foot Plating System (K1 10670, K090675) Smith & Nephew, Peri-Loc Ankle Fusion Plating System (K120667) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657) Intended Use / Indications for .Use The Flow… | 2012 |
| * | K123562 | Flower Small and Medium Bone ImplantsSummary page 1…LP Foot Plating System (K1 10670, K090675) Smith & Nephew, Peri-Loc Ankle Fusion Plating System (K120667) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657) Intended Use / Indications for .Use The Flower Rearfoot Plating Set is intended to be used for internal fixati… | 2013 |
| * | K131657 | Flower Small and Medium Implant SetSummary page 1…lating System (K1 10670, K090675) Smith & Nephew, Peri-Loc Ankle Fusion Plating System (K120667) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657) Intended Use / Indications for .Use The Flower Rearfoot Plating Set is intended to be used for internal fixation of fra… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2020 | Class II | Z-2782-2020 | Mixed-up of materials/components | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Class II | Z-2784-2020 | Mixed-up of materials/components | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Class II | Z-2785-2020 | Mixed-up of materials/components | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Class II | Z-2787-2020 | Mixed-up of materials/components | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Class II | Z-2786-2020 | Mixed-up of materials/components | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Jul 8, 2020 | Class II | Z-2783-2020 | Mixed-up of materials/components | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 28 of the 128 ancestors have a recall of any class.
- 15 other devices also cite its predicate K991407.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. Examples of these Internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133930: Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot 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/K133930
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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