510(k) · Cleared
ClearedSynthes Anatomical Locking Plate System
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 Aug 7, 1996 after a 117-day review. The FDA summary names its predicate without a number. 93 later devices descend from it.
- Decided
- Aug 7, 1996
- Review
- 117 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
93 later devices descend from it, 8 citing it directly.
- This deviceK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
- Descendant · cites it directly · 68 of its ownK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- Descendant · 2 generations on · 25 of its ownK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
- Descendant · 2 generations on · 21 of its ownK081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer…Zimmer GmbH · 2008 · Recalled
- Descendant · 2 generations on · 20 of its ownK121672 Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012
- Descendant · 2 generations on · 18 of its ownK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K042695NCB Plating SystemZimmer GmbH · 2004 · cites it directly68descendants
- K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · 2 generations on25descendants
- K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH · 2008 · 2 generations on21descendants
- K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012 · 2 generations on20descendants
- K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961413 | Synthes Anatomical Locking Plate System | Synthes (Usa) | 1996 | — |
| +1 | K042695 | NCB Plating System | Zimmer GmbH | 2004 | 1 |
| +2 | K061211 | NCB Plating System, Proximal Tibia Plates | Zimmer GmbH | 2006 | 4 |
| +2 | K081759 | NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal… | Zimmer GmbH | 2008 | 2 |
| +2 | K121672 | Aft Proximal Humerus Fracture Plate | Shoulder Options, Inc. | 2012 | — |
| +2 | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | Zimmer, Inc. | 2010 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 7 | 0 |
| 2026 | 10 | 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? (5)
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 PC-Fix Named without a submission number | |
| * | — | Condylar Plate 95° Named without a submission number | |
| * | — | Condylar Buttress Plate Named without a submission number | |
| * | — | 4.5 mm Cortex Screws Named without a submission number | |
| * | — | 6.5 mm Cancellous Screws Named without a submission number |
What descends from it? (93)
See all 938 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042695 | NCB Plating System | 2004 | 68 |
| K113733 | Small and Large Fragments Osteosynthesis System Neofix | 2012 | 11 |
| K192745 | DePuy Synthes Trauma Screws | 2019 | 5 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 | 3 |
| K093868 | I.T.S. LRS Locking Reconstruction System | 2010 | 1 |
| K111891 | Synthes Brainlab Trauma Compatible Instruments | 2011 | 0 |
| K110592 | 3.7MM/5.0MM Dynamic Locking Screw | 2011 | 0 |
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?
- Of its descendants, K042695 (Zimmer GmbH, 2004) has gone furthest, with 68 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?
Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula and femur.
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/K961413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961413: Synthes Anatomical Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961413
Report an extraction error
Are you the manufacturer?
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