510(k) · Cleared
ClearedGFS - Sterile Screws and Top Hat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
T.A.G. Medical Products Corporation, Ltd. · HWC Screw, Fixation, Bone
Cleared on Aug 5, 2026 as substantially equivalent to K110763 (T.A.G. Medical Products Corporation, Ltd., 2011) and 1 other predicate after a 245-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Aug 5, 2026
- Review
- 245 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903811 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK903811 Ace Cannulated Cortical Bone ScrewAce Medical Co. · 1990
- 3 generations backK083096 Latarjet Cortical Screw SetTag Medical Products · 2009 · Recalled
- 2 generations backK091694 Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J…Tag Medical Products · 2009 · Recalled
- 1 generation backK110763 Latarjet Cortical Screw SetT.A.G. Medical Products Corporation, Ltd. · 2011 · Recalled
- This deviceK253858 GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903811 | Ace Cannulated Cortical Bone Screw | Ace Medical Co. | 1990 | — |
| −3 | K083096 | Latarjet Cortical Screw Set | Tag Medical Products | 2009 | 5 |
| −2 | K091694 | Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM) | Tag Medical Products | 2009 | 5 |
| −1 | K110763 | Latarjet Cortical Screw Set | T.A.G. Medical Products Corporation, Ltd. | 2011 | 5 |
| 0 (this device) | K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K110763 | Latarjet Cortical Screw SetSummary page 5…threaded metallic bone fixation fastener Classification Class II Product Code HWC Regulation Number 21 CFR 888.3040 Predicate Device K110763 – Latarjet Cortical Screw Set K083096 – Latarjet Cortical Screw Set Reference Devices K091694 – Lat… | 2011 |
| * | K083096 | Latarjet Cortical Screw SetSummary page 5…Class II Product Code HWC Regulation Number 21 CFR 888.3040 Predicate Device K110763 – Latarjet Cortical Screw Set K083096 – Latarjet Cortical Screw Set Reference Devices K091694 – Latarjet Cortical Screw Set K101616 – Gra… | 2009 |
| † | K091694 | Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM) | 2009 |
| † | K101616 | The Grapplr and Grapplr Extender | 2011 |
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 36 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 3 of the 4 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. 2026, 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 GFS Sterile Screws and Top Hat are intended to provide orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries for cortical bone in the shoulder.
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/K253858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253858: GFS - Sterile Screws and Top Hat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253858
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026