510(k) · Cleared
ClearedTAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus 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 Jul 19, 2023 as substantially equivalent to K213864 (Bonebridge AG, 2022) and 6 other predicates after a 76-day review. Its family tree reaches back 12 generations to 1996. 7 later devices descend from it.
- Decided
- Jul 19, 2023
- Review
- 76 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K962616 (1996). 118 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 1 generation backK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- This deviceK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
- Descendant · cites it directly · 4 of its ownK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
- Descendant · cites it directly · 1 of its ownK250933 LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025
- Descendant · 2 generations on · 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 · 3 generations on · 0 of its ownK261351 SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 1 generation backK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- This deviceK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K240318SITTER 3.5mm Versatile SystemBonebridge AG · 2024 · cites it directly4descendants
- K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025 · cites it directly1descendant
- K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG · 2024 · 2 generations on1descendant
- K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024 · cites it directly1descendant
- K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −1 | K213864 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2022 | — |
| 0 (this device) | K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia… | Bonebridge AG | 2023 | — |
| +1 | K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | 2024 | — |
| +1 | K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | Bonebridge AG | 2025 | — |
| +2 | K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System… | Bonebridge AG | 2024 | — |
| +1 | K242399 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2024 | — |
| +3 | K261351 | SALGINA 2.5mm Distal Radius 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 | 3 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K213864 | Bonebridge Osteosynthesis Plating SystemSummary page 4…STRATIVE INFORMATION Date prepared July 07, 2023 Submission type: Traditional 510(k) Purpose of 510(k): Modification of currently cleared device K213864 Line extension of the cleared K213864 TAMINA 3.5mm Proximal Humerus System and PO… | 2022 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 5…lating System (K213864) TAMINA 3.5mm Proximal Humerus System Additional predicate devices: TAMINA 3.5mm Proximal Humerus System K041860 Synthes (USA) LCP® Proximal Humerus Plates, Long… | 2004 |
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 5…Humerus System K041860 Synthes (USA) LCP® Proximal Humerus Plates, Long K011815 Synthes LCP Proximal Humerus Plates K08… | 2001 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 5…K011815 Synthes LCP Proximal Humerus Plates K082807 Synthes (USA) 3.5mm and 4.5mm Locking Compression Plate (LCP) System with… | 2008 |
| * | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSummary page 5…Locking Compression Plate (LCP) System with Expanded Indications POYA 3.5mm Lateral Proximal Tibia K120689 SYNTHES 3.5 mm Variable Angle LCP System (POYA-L) Proximal Tibia Plate system… | 2012 |
| * | K120070 | Synthes Variable Angle LCP Elbow SystemSummary page 5…Locking Compression Plate (LCP) System with Expanded Indications LORRAINE 3.5mm Distal Humerus System K120070 Synthes Variable Angle LCP Elbow System / Distal Humerus Plates… | 2012 |
| * | K101056 | Variax Elbow SystemSummary page 5…K120070 Synthes Variable Angle LCP Elbow System / Distal Humerus Plates K101056 VariAx Elbow System / Distal Humerus Plates… | 2010 |
What descends from it? (7)
4 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 27 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 25 of the 118 ancestors have a recall of any class.
- Of its descendants, K240318 (Bonebridge AG, 2024) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K213864.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
TAMINA 3.5mm Proximal Humerus System The TAMINA, TAMINA Long and TAMINA-TF Proximal Humerus System is indicated for • Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic bone • Pseudarthroses (non-unions) of the proximal humerus • Osteotomies of the proximal humerus POYA 3.5mm Lateral Proximal Tibia System The POYA 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation…
Read the full statement (160 words)
TAMINA 3.5mm Proximal Humerus System
The TAMINA, TAMINA Long and TAMINA-TF Proximal Humerus System is indicated for
• Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic
bone
• Pseudarthroses (non-unions) of the proximal humerus
• Osteotomies of the proximal humerus
POYA 3.5mm Lateral Proximal Tibia System
The POYA 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation of fractures of the proximal tibia in
adults and skeletally mature adolescents including:
• simple fractures
• comminuted fractures
• lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures
• depression fractures
• periprosthetic fractures
• nonunions, malunions, tibial osteotomies and osteopenic bone
• fractures with associated shaft fractures
LORRAINE 3.5mm Distal Humerus System
The LORRAINE 3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal
humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures
with diaphyseal extension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231292
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