510(k) · Cleared
Recalled · Class II · 2015Flower Small and Medium Implant 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 Aug 22, 2013 as substantially equivalent to K123562 (Flower Orthopedics Corporation, 2013) and 3 other predicates after a 77-day review. Its family tree reaches back 6 generations to 1996. 11 later devices descend from it. It has been recalled once.
- Decided
- Aug 22, 2013
- Review
- 77 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K954385 (1996). 57 ancestors in all, the oldest K800806 (1980). 11 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 4 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 3 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 2 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 1 generation backK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
- This deviceK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013
- Descendant · cites it directly · 7 of its ownK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
- Descendant · 2 generations on · 6 of its ownK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · Recalled
- Descendant · 3 generations on · 3 of its ownK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
- Descendant · 3 generations on · 2 of its ownK223342 MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion…Crossroads Extremity Systems, LLC · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015 · cites it directly7descendants
- K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016 · 2 generations on6descendants
- K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · 2 generations on4descendants
- K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020 · 3 generations on3descendants
- K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −5 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −4 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −3 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −2 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −1 | K123562 | Flower Small and Medium Bone Implants | Flower Orthopedics Corporation | 2013 | 2 |
| 0 (this device) | K131657 | Flower Small and Medium Implant Set | Flower Orthopedics Corporation | 2013 | — |
| +1 | K152306 | MotoBand¿ CP Implant System | Crossroads Extremity Systems, LLC | 2015 | — |
| +2 | K160300 | MotoBand (TM) CP Implant System | Crossroads Extremity Systems, LLC | 2016 | — |
| +2 | K173710 | MotoBAND CP Implant System | Crossroads Extremity Systems, LLC | 2018 | 1 |
| +3 | K193452 | MotoBAND CP Implant System | Crossroads Extemity Systems, LLC | 2020 | — |
| +3 | K223342 | MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System… | Crossroads Extremity Systems, LLC | 2023 | — |
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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K123562 | Flower Small and Medium Bone ImplantsSummary page 1…n Panel [[ Orthopedic and Rehabilitation Devices PanelJ Predicate Devices: Flower Small and Medium Implant Set (K123562) ISynthes USA's 3.5 mmr and 4.5 mm Locking… | 2013 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 1…m Locking Compression Plate (LCP) System with Expanded Indications (K082807) Stryker's VariAx Distal Radius Locked Plating System… | 2008 |
| * | K112455 | Aiming Blocks for Variax Distal Radius Plates | 2011 |
| * | K040598 | KLS Martin Hand Plating SystemSummary page 1…ddition of Aiming Blocks (KI 12455) KLS-Martin Hand Plating System (K040598) CHANGE FROM PREDICATE: The purpose of this submission is to make modifications (line extensions) to the components of the Flowe… | 2004 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2015 | Class II | Z-1314-2015 | Device Design | Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 13 of the 57 ancestors have a recall of any class.
- Of its descendants, K152306 (Crossroads Extremity Systems, LLC, 2015) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K123562.
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 Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions.
This system can be used for palmar, ventral, dorsal or orthogonal application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131657: Flower Small and Medium Implant Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131657
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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