510(k) · Cleared
ClearedFlower Bone Screw Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flower Orthopedics Corporation · HWC Screw, Fixation, Bone
Cleared on Jun 6, 2017 as substantially equivalent to K132248 (Flower Orthopedics Corporation, 2013) and 2 other predicates after a 91-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Jun 6, 2017
- Review
- 91 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K962823 (1996). 103 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 2 generations backK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
- 1 generation backK132248 Flower Bone Screw SetFlower Orthopedics Corporation · 2013
- This deviceK170687 Flower Bone Screw SetFlower Orthopedics Corporation · 2017
Show all 9 generations
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 8 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 7 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 6 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 5 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 4 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 3 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 2 generations backK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
- 1 generation backK132248 Flower Bone Screw SetFlower Orthopedics Corporation · 2013
- This deviceK170687 Flower Bone Screw SetFlower Orthopedics Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −8 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −7 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −6 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −5 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −4 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −3 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −2 | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical… | Medical Facets | 2012 | — |
| −1 | K132248 | Flower Bone Screw Set | Flower Orthopedics Corporation | 2013 | — |
| 0 (this device) | K170687 | Flower Bone Screw Set | Flower Orthopedics Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 10 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K132248 | Flower Bone Screw SetSummary page 4…duct Code: HWC); Product classification: 21 C.F.R. 888.3040 – Smooth or threaded metallic bone fixation fastener Predicate Devices Flower Bone Screw Set (K132248) Flower Small and Medium Implant Set (K123562) Medical Facet’s Bone Fixation Screws and Pins (K112727) Intended Us… | 2013 |
| * | K123562 | Flower Small and Medium Bone ImplantsSummary page 4…8.3040 – Smooth or threaded metallic bone fixation fastener Predicate Devices Flower Bone Screw Set (K132248) Flower Small and Medium Implant Set (K123562) Medical Facet’s Bone Fixation Screws and Pins (K112727) Intended Use / Indications for Use The Flower Bone Screw… | 2013 |
| * | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Summary page 4…ner Predicate Devices Flower Bone Screw Set (K132248) Flower Small and Medium Implant Set (K123562) Medical Facet’s Bone Fixation Screws and Pins (K112727) Intended Use / Indications for Use The Flower Bone Screw Set is intended to be used for the fixation of bone fractures,… | 2012 |
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 21 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 16 of the 103 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Flower Bone Screw Set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170687: Flower Bone Screw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170687
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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