510(k) · Cleared
Recalled · Class II · 2016Synthes (Usa) [Synthes} Peri-Prosthetic Screws
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 Sep 1, 2004 after an 85-day review. The FDA summary names its predicate without a number. 108 later devices descend from it. It has been recalled once.
- Decided
- Sep 1, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 0
108 later devices descend from it, 4 citing it directly.
- This deviceK041533 Synthes (Usa) [Synthes} Peri-Prosthetic ScrewsSynthes (Usa) · 2004
- Descendant · cites it directly · 62 of its ownK110354 4.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · Recalled
- Descendant · 2 generations on · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- Descendant · cites it directly · 26 of its ownK141121 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014
- Descendant · 2 generations on · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
- Descendant · 3 generations on · 24 of its ownK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · cites it directly62descendants
- K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
- K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014 · cites it directly26descendants
- K153379AxSOS 3TiStryker GmbH · 2016 · 2 generations on25descendants
- K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041533 | Synthes (Usa) [Synthes} Peri-Prosthetic Screws | Synthes (Usa) | 2004 | — |
| +1 | K110354 | 4.5MM VA-LCP Curved Condylar Plate System | Synthes USA | 2011 | 2 |
| +2 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| +1 | K141121 | Axsos 3 TI Locking Plate System | Stryker Trauma AG | 2014 | — |
| +2 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| +3 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 12 | 0 |
| 2024 | 13 | 0 |
| 2025 | 11 | 0 |
| 2026 | 17 | 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? (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 4.0/5.0 mm Locking Screws Named without a submission number |
What descends from it? (108)
See all 1084 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 |
|---|---|---|---|---|
| Apr 4, 2016 | Class II | Z-1574-2016 | Process control | This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110354 (Synthes USA, 2011) has gone furthest, with 62 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?
The Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with Synthes locking plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of non-unions or malunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041533: Synthes (Usa) [Synthes} Peri-Prosthetic Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041533
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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