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
T.A.G. Medical Products Corporation, Ltd. · HWC Screw, Fixation, Bone
Cleared on Apr 11, 2011 as substantially equivalent to K083096 (Tag Medical Products, 2009) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Apr 11, 2011
- Review
- 24 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 3 generations to K903811 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK903811 Ace Cannulated Cortical Bone ScrewAce Medical Co. · 1990
- 2 generations backK083096 Latarjet Cortical Screw SetTag Medical Products · 2009 · Recalled
- 1 generation backK091694 Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J…Tag Medical Products · 2009 · Recalled
- This deviceK110763 Latarjet Cortical Screw SetT.A.G. Medical Products Corporation, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK253858 GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903811 | Ace Cannulated Cortical Bone Screw | Ace Medical Co. | 1990 | — |
| −2 | K083096 | Latarjet Cortical Screw Set | Tag Medical Products | 2009 | 5 |
| −1 | K091694 | Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM) | Tag Medical Products | 2009 | 5 |
| 0 (this device) | K110763 | Latarjet Cortical Screw Set | T.A.G. Medical Products Corporation, Ltd. | 2011 | — |
| +1 | K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083096 | Latarjet Cortical Screw SetSummary page 1…one Fixation Screw, class 11device (product code HWC). Name: Latarjet Cortical Screw Set 3. Predicate Device: The Latarjet Cortical Screw Set K083096 &K091694 4. Description: The Latarjet Cortical Screw Set consists of an implantable fixation screw… | 2009 |
| * | K091694 | Modification to:Latarjet Cortical Screw Set, Models 523JT, 523J (36-48MM)Summary page 1…ion Screw, class 11device (product code HWC). Name: Latarjet Cortical Screw Set 3. Predicate Device: The Latarjet Cortical Screw Set K083096 &K091694 4. Description: The Latarjet Cortical Screw Set consists of an implantable fixation screw w… | 2009 |
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 |
|---|---|---|---|
| K253858 | GFS - Sterile Screws and Top Hat | 2026 | 0 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K253858 (T.A.G. Medical Products Corporation, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K083096.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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/K110763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110763: Latarjet Cortical Screw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110763
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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