510(k) · Cleared
ClearedTI. Alloy 2.0 MM Cortex Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HWC Screw, Fixation, Bone
Cleared on Jul 31, 1995 after a 77-day review. The FDA summary names its predicate without a number. 1 of the 195 devices in its family, counting itself, has a Class I recall. 194 later devices descend from it.
- Decided
- Jul 31, 1995
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
194 later devices descend from it, 3 citing it directly. 1 of the 195 devices in this family, counting this one, has a Class I recall.
- This deviceK952272 TI. Alloy 2.0 MM Cortex ScrewSynthes (Usa) · 1995
- Descendant · cites it directly · 135 of its ownK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- Descendant · cites it directly · 92 of its ownK962233 Twist-Off ScrewLandos, Inc. · 1996
- Descendant · 2 generations on · 84 of its ownK070039 Memometal Fixos ScrewsMemometal Technologies · 2007
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 3 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 194 · See all- K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · cites it directly135descendants
- K962233Twist-Off ScrewLandos, Inc. · 1996 · cites it directly92descendants
- K070039Memometal Fixos ScrewsMemometal Technologies · 2007 · 2 generations on84descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 3 generations on74descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952272 | TI. Alloy 2.0 MM Cortex Screw | Synthes (Usa) | 1995 | — |
| +1 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| +1 | K962233 | Twist-Off Screw | Landos, Inc. | 1996 | — |
| +2 | K070039 | Memometal Fixos Screws | Memometal Technologies | 2007 | — |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +3 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 16 | 0 |
| 2016 | 3 | 0 |
| 2017 | 10 | 0 |
| 2018 | 3 | 0 |
| 2019 | 11 | 0 |
| 2020 | 11 | 0 |
| 2021 | 10 | 1 |
| 2022 | 18 | 0 |
| 2023 | 21 | 0 |
| 2024 | 26 | 0 |
| 2025 | 21 | 0 |
| 2026 | 30 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | — | Synthes 2.0 mm Cortex Screw Named without a submission number |
What descends from it? (194)
See all 1943 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K112885 (Zimmer, Inc., 2011) has gone furthest, with 135 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Synthes Ti. Alloy 2.0 mm Cortex Screw is intended for fixation of fractures of the fingers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K952272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952272: TI. Alloy 2.0 MM Cortex Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952272
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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