510(k) · Cleared
Recalled · Class II · 2017Latarjet Cortical Screw Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tag Medical Products · HWC Screw, Fixation, Bone
Cleared on Apr 17, 2009 as substantially equivalent to K903811 (Ace Medical Co., 1990) after a 182-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 17, 2009
- Review
- 182 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903811 (1990). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK903811 Ace Cannulated Cortical Bone ScrewAce Medical Co. · 1990
- This deviceK083096 Latarjet Cortical Screw SetTag Medical Products · 2009
- Descendant · cites it directly · 2 of its ownK091694 Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J…Tag Medical Products · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK110763 Latarjet Cortical Screw SetT.A.G. Medical Products Corporation, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK253858 GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK240175 Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical · 2024
Most influential descendants
Showing 4 of 4 · See all- K091694Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM)Tag Medical Products · 2009 · cites it directly2descendants
- K110763Latarjet Cortical Screw SetT.A.G. Medical Products Corporation, Ltd. · 2011 · cites it directly1descendant
- K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd. · 2026 · cites it directly0descendants
- K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903811 | Ace Cannulated Cortical Bone Screw | Ace Medical Co. | 1990 | — |
| 0 (this device) | K083096 | Latarjet Cortical Screw Set | Tag Medical Products | 2009 | — |
| +1 | 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 |
| +1 | K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026 | — |
| +1 | K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | Tigon Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K903811 | Ace Cannulated Cortical Bone ScrewSummary page 1…ne Fixation Screw, class II device (product code HWC). Name: Latarjet Cortical Screw Set 3. Predicate Device: Depuy Cannulated Bone Screw K90381 1 Synthes 3mm Cannulated Bone Screw System K892823 4. Description: The Latarjet Cortical… | 1990 |
| Kept off the family tree | K892823 | FDA’s K892823 is Plaster Cutting Scissors Our reading of the summary gave K892823, FDA’s number for Plaster Cutting Scissors (The South India Surgical Co. Pvt., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Synthes 3mm Cannulated Bone Screw System”. Kept off the family tree. Summary page 1…Latarjet Cortical Screw Set 3. Predicate Device: Depuy Cannulated Bone Screw K90381 1 Synthes 3mm Cannulated Bone Screw System K892823 4. Description: The Latarjet Cortical Screw Set consists of an implantable fixation screw… | 1989 |
What descends from it? (4)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2017 | Class II | Z-2618-2017 | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw |
| May 12, 2017 | Class II | Z-2615-2017 | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw |
| May 12, 2017 | Class II | Z-2619-2017 | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw |
| May 12, 2017 | Class II | Z-2616-2017 | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw |
| May 12, 2017 | Class II | Z-2617-2017 | Component design/selection | Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083096: Latarjet Cortical 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/K083096
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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