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 Oct 30, 2013 as substantially equivalent to K112727 (Medical Facets, 2012) and 4 other predicates after a 103-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Oct 30, 2013
- Review
- 103 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K962823 (1996). 102 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 1 generation backK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
- This deviceK132248 Flower Bone Screw SetFlower Orthopedics Corporation · 2013
- Descendant · cites it directly · 0 of its ownK170687 Flower Bone Screw SetFlower Orthopedics Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K170687Flower Bone Screw SetFlower Orthopedics Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −1 | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical… | Medical Facets | 2012 | — |
| 0 (this device) | K132248 | Flower Bone Screw Set | Flower Orthopedics Corporation | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Summary page 1…R. 858.3030 - Single/multiple component metallic bone fixation appliances and accessories Predicate Devices Medical Facets Bone Fixation Screws and Pins (K1 12727) Howmedica Asnis Micro Cannulated Screw (K071092) Treu Bone Fixation Screws and Pins (K053912) Synthes 4.5mm… | 2012 |
| * | K071092 | Asnis Micro Cannulated ScrewSummary page 1…ation appliances and accessories Predicate Devices Medical Facets Bone Fixation Screws and Pins (K1 12727) Howmedica Asnis Micro Cannulated Screw (K071092) Treu Bone Fixation Screws and Pins (K053912) Synthes 4.5mm and 6.5mm Headless Compression Screws (K080943)… | 2007 |
| * | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins Our reading of the summary gave K053912, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Treu Bone Fixation Screws and Pins”. | 2009 |
| * | K080943 | Synthes 4.5 MM and 6.5 MM Headless Compression ScrewsSummary page 1…) Howmedica Asnis Micro Cannulated Screw (K071092) Treu Bone Fixation Screws and Pins (K053912) Synthes 4.5mm and 6.5mm Headless Compression Screws (K080943) Flower Small and Medium Implant Set (K1 23562) Intended Use / Indications for Use The Flower Bone Screw set is inte… | 2008 |
| * | K123562 | Flower Small and Medium Bone ImplantsSummary page 1…092) Treu Bone Fixation Screws and Pins (K053912) Synthes 4.5mm and 6.5mm Headless Compression Screws (K080943) Flower Small and Medium Implant Set (K1 23562) Intended Use / Indications for Use The Flower Bone Screw set is intended to be used for the fixation of bone fractures, fu… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170687 | Flower Bone Screw Set | 2017 | 0 |
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 8 companies; a new generation was cleared every 2.4 years on median.
- 16 of the 102 ancestors have a recall of any class.
- Of its descendants, K170687 (Flower Orthopedics Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K112727.
How does its category compare?
All HWC devicesHWC Screw, 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 · 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/K132248 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132248: Flower Bone Screw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132248
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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