510(k) · Cleared
ClearedSynthes Brainlab Trauma Compatible Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Nov 28, 2011 as substantially equivalent to K040336 (Synthes (Usa), 2004) and 4 other predicates after a 146-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Nov 28, 2011
- Review
- 146 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K982222 (1998). 6 ancestors in all, the oldest K961413 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982222 | Synthes (Usa) Distal Femur Plate (DFP) System | Synthes (Usa) | 1998 | — |
| −1 | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) System | Synthes (Usa) | 2000 | — |
| 0 (this device) | K111891 | Synthes Brainlab Trauma Compatible Instruments | Synthes (USA) Products, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 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 |
|---|---|---|---|
| * | K040336 | Synthes (Usa) Lateral Entry Femoral Nail SystemSummary page 1…n, Nail/Blade Combination, Multiple Component). Predicate Synthes (USA) Synthes Lateral Entry Femoral Nail (K040336) Devices:Synthes LISS System (Synthes Anatomic Locking Plate System) (K(961413)… | 2004 |
| * | K961413 | Synthes Anatomical Locking Plate SystemSummary page 3…cate Synthes Lateral Entry Femoral Nail (K040336), Synthes Distal Femur LISS (Synthes Anatomic Locked Plating System, K961413), Synthes Locking Condylar Plate System (K000066), Synthes LCP Curved Condylar Plate System (K041911 1)… | 1996 |
| * | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) SystemSummary page 1…L1SS System (Synthes Anatomic Locking Plate System) (K(9614 13) Synthes (USA) Locking Condylar Plate System (K000066) Synthes (USA) LCP Curved Condylar Plates (K04191 1) Synthes LCP Distal Femur Plates (K062564) to… | 2000 |
| * | K041911 | Synthes (Usa) LCP Curved PlatesSummary page 1…(K(9614 13) Synthes (USA) Locking Condylar Plate System (K000066) Synthes (USA) LCP Curved Condylar Plates (K04191 1) Synthes LCP Distal Femur Plates (K062564) to introduce modified instruments, which arc manual acces… | 2004 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 1…lar Plate System (K000066) Synthes (USA) LCP Curved Condylar Plates (K04191 1) Synthes LCP Distal Femur Plates (K062564) to introduce modified instruments, which arc manual accessory instrume… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 8 other devices also cite its predicate K040336.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System Synthes ALPS System is a plate and screw system intended to treat fractures of…
Read the full statement (330 words)
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes ALPS System is a plate and screw system intended to treat fractures of various long bones including radius, ulna, humerus, tibia, fibula, and femur. The Synthes ALPS is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP System is intended for buttressing multi-fragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non - unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
The Synthes Curved Broad Plates are intended for fixation of various long bone, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and non-unions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma navigation system
The Synthes Curved Condylar Plates are intended for buttressing multi fragmentary distal femur fractures, including: supracondylar, intra-articular and extra articular condylar fractures, peni-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malun ions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP Distal Femur Plates are intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111891: Synthes Brainlab Trauma Compatible Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111891
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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