510(k) · Cleared
ClearedSITTER 3.5mm Versatile System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonebridge AG · HRS Plate, Fixation, Bone
Cleared on Aug 23, 2024 as substantially equivalent to K231292 (Bonebridge AG, 2023) and 1 other predicate after a 203-day review. Its family tree reaches back 13 generations to 1996. 4 later devices descend from it.
- Decided
- Aug 23, 2024
- Review
- 203 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K962616 (1996). 119 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 2 generations backK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- 1 generation backK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
- This deviceK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
- Descendant · cites it directly · 1 of its ownK243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal…Bonebridge AG · 2024
- Descendant · cites it directly · 1 of its ownK242399 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024
- Descendant · 2 generations on · 0 of its ownK261351 SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026
- Descendant · 2 generations on · 0 of its ownK260228 POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG · 2026
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 3 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 2 generations backK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- 1 generation backK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
- This deviceK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
Most influential descendants
Showing 4 of 4 · See all- K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG · 2024 · cites it directly1descendant
- K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024 · cites it directly1descendant
- K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026 · 2 generations on0descendants
- K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −3 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −2 | K213864 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2022 | — |
| −1 | K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia… | Bonebridge AG | 2023 | — |
| 0 (this device) | K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | 2024 | — |
| +1 | K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System… | Bonebridge AG | 2024 | — |
| +1 | K242399 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2024 | — |
| +2 | K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026 | — |
| +2 | K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 8 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 2 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Summary page 4…ATIVE INFORMATION Date prepared July 29, 2024 Submission type: Traditional 510(k) Purpose of 510(k): Modification of currently cleared device K231292 Introduction of an additional plating system SITTER 3.5mm Versatile System… | 2023 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 5…esis Plating System (K231292) TAMINA 3.5mm Proximal Humerus System Additional predicate devices: SITTER 3.5mm Versatile System K082807 Synthes (USA) 3.5 mm Locking Compression Plate (LCP) System with… | 2008 |
What descends from it? (4)
2 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)
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 28 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 25 of the 119 ancestors have a recall of any class.
- Of its descendants, K243308 (Bonebridge AG, 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K231292.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.
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/K240318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240318: SITTER 3.5mm Versatile System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240318
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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