510(k) · Cleared
ClearedOsteoBullet Compression Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phalanx Innovations · HWC Screw, Fixation, Bone
Cleared on Apr 29, 2016 as substantially equivalent to K060026 (Koby Surgical, 2006) and 1 other predicate after an 85-day review. Its family tree reaches back 6 generations to 1979. 8 later devices descend from it.
- Decided
- Apr 29, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K792022 (1979). 21 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 4 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 3 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 2 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 1 generation backK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
- This deviceK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
- Descendant · cites it directly · 3 of its ownK180257 InCore® Lapidus SystemNextremity Solutions, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK200291 CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK192578 InCore TMT SystemNextremity Solutions, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK252657 Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK223847 CREED™ Cannulated ScrewsGlw, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K180257InCore® Lapidus SystemNextremity Solutions, Inc. · 2018 · cites it directly3descendants
- K200291CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020 · cites it directly2descendants
- K192578InCore TMT SystemNextremity Solutions, Inc. · 2019 · 2 generations on1descendant
- K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025 · cites it directly0descendants
- K223847CREED™ Cannulated ScrewsGlw, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −5 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −4 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −3 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −2 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −1 | K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) | Inion OY | 2013 | — |
| 0 (this device) | K160304 | OsteoBullet Compression Screw | Phalanx Innovations | 2016 | — |
| +1 | K180257 | InCore® Lapidus System | Nextremity Solutions, Inc. | 2018 | — |
| +1 | K200291 | CREED™ Cannulated Screws | Glw Medical, Inc. | 2020 | — |
| +2 | K192578 | InCore TMT System | Nextremity Solutions, Inc. | 2019 | — |
| +1 | K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025 | — |
| +2 | K223847 | CREED™ Cannulated Screws | Glw, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K060026 | Koby Surgical Internal Fixation SystemSummary page 4…ation Number 21 CFR 888.3040 Product Code HWC Name of Predicate/Reference 510(k) # Manufacturer Device Ti6® Internal Fixation System K060026 Integra (cleared under Koby Surgical) (cleared as Koby Surgical Internal Fixation System) Inion Freedom Screw™… | 2006 |
| * | K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Summary page 4…nal Fixation System K060026 Integra (cleared under Koby Surgical) (cleared as Koby Surgical Internal Fixation System) Inion Freedom Screw™ K123672 Inion Oy DARCO Headless Compression K080850 Wright Medical Technology, Inc. Screw (Referenc) Descript… | 2013 |
| † | K080850 | Darco Headless Compression Screw | 2008 |
What descends from it? (8)
3 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)
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 37 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K180257 (Nextremity Solutions, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K060026.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160304: OsteoBullet Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160304
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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