510(k) · Cleared
Recalled · 2010Synthes (Usa) Modular Blade Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Mar 20, 2008 as substantially equivalent to K914546 (Synthes (Usa), 1991) after a 65-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled 56 times.
- Decided
- Mar 20, 2008
- Review
- 65 days
- Class
- Class II
- Product code
- KTW
- Recalls
- 56
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914546 (1991). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914546 | Angled Blade Plate | Synthes (Usa) | 1991 | — |
| 0 (this device) | K080109 | Synthes (Usa) Modular Blade Plate System | Synthes (Usa) | 2008 | — |
| +1 | K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | Pega Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K914546 | Angled Blade PlateSummary page 1…ultiple component metallic bone fixation appliances and accessories. Predicate Device: Synthes Angled Blade Plates (Pre-amendment and K914546) Device Description: The Synthes (USA) Modular Blade Plate System is comprised of a spiral bla… | 1991 |
| * | — | Synthes Angled Blade Plates (Pre-amendment) Named without a submission number |
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 |
|---|---|---|---|
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 27, 2010 | Not classified | Z-1280-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1314-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1308-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1265-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1279-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1302-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1297-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1296-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1269-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1315-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1272-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1281-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1274-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1307-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1270-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1304-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1306-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1267-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1303-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1275-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1316-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1285-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1318-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1268-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1271-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1317-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1305-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1262-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1288-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1292-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1264-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1299-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1289-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1298-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1311-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1293-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1301-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1266-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1286-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1309-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1277-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1284-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1283-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1278-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1294-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-300-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1263-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1310-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1290-2011 | Other | Potential for out of specification star grind teeth. |
| Oct 27, 2010 | Not classified | Z-1313-2011 | Other | Potential for out of specification star grind teeth. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080109: Synthes (Usa) Modular Blade Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080109
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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