510(k) · Cleared
ClearedFlower Upper Extremity 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 Sep 15, 2014 as substantially equivalent to K012655 (Acu Med, Inc., 2001) and 4 other predicates after a 27-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Sep 15, 2014
- Review
- 27 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K954385 (1996). 60 ancestors in all, the oldest K800806 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 5 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 4 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 3 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 2 generations backK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
- 1 generation backK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
- This deviceK142306 Flower Upper Extremity Plating SetFlower Orthopedics Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −6 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −5 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −4 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −3 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −2 | K123562 | Flower Small and Medium Bone Implants | Flower Orthopedics Corporation | 2013 | 2 |
| −1 | K131657 | Flower Small and Medium Implant Set | Flower Orthopedics Corporation | 2013 | 1 |
| 0 (this device) | K142306 | Flower Upper Extremity Plating Set | Flower Orthopedics Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K012655 | Congruent Bone Plate SystemSummary page 4…de HWC (21 C.F.R. 888.3040, Smooth or threaded metallic bone fixation fastener; Class II). Predicate Devices Acumed Inc., Congruent Bone Plating System (K012655, K063640, K071715) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657) Intended Use / Indications for Use… | 2001 |
| * | K063460 | Acumed Congruent Bone Plate System Our reading of the summary gave K063640, FDA’s number for Kowa SL-15 (Kowa Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Acumed Inc., Congruent Bone Plating System”. | 2006 |
| * | K071715 | Acumed Congruent Bone Plate SystemSummary page 4…888.3040, Smooth or threaded metallic bone fixation fastener; Class II). Predicate Devices Acumed Inc., Congruent Bone Plating System (K012655, K063640, K071715) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657) Intended Use / Indications for Use The Flowe… | 2007 |
| * | K123562 | Flower Small and Medium Bone ImplantsSummary page 4…r; Class II). Predicate Devices Acumed Inc., Congruent Bone Plating System (K012655, K063640, K071715) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657) Intended Use / Indications for Use The Flower Upper Extremity Plating Set is intended to be used for fixation… | 2013 |
| * | K131657 | Flower Small and Medium Implant SetSummary page 4…II). Predicate Devices Acumed Inc., Congruent Bone Plating System (K012655, K063640, K071715) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657) Intended Use / Indications for Use The Flower Upper Extremity Plating Set is intended to be used for fixation of fractu… | 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 18 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 60 ancestors have a recall of any class.
- 27 other devices also cite its predicate K012655.
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 Upper Extremity Plating Set is intended to be used for fixation of fractures, fusions, or osteotomies of the clavicle, humerus, radius and ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142306: Flower Upper Extremity 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/K142306
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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