510(k) · Cleared
ClearedMahe Fixation Plate and Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mahe Medical GmbH · HRS Plate, Fixation, Bone
Cleared on May 13, 2011 as substantially equivalent to K083654 (Zimmer, Inc., 2009) and 3 other predicates after a 226-day review. Its family tree reaches back 7 generations to 1996. 8 later devices descend from it.
- Decided
- May 13, 2011
- Review
- 226 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K962823 (1996). 41 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 5 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 4 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 3 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 2 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 1 generation backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- This deviceK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- Descendant · cites it directly · 4 of its ownK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
- Descendant · 3 generations on · 1 of its ownK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
- Descendant · 2 generations on · 1 of its ownK202764 Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017 · cites it directly4descendants
- K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · 2 generations on3descendants
- K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly2descendants
- K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021 · 3 generations on1descendant
- K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −6 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −5 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −4 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −2 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −1 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| 0 (this device) | K102845 | Mahe Fixation Plate and Screw System | Mahe Medical GmbH | 2011 | — |
| +1 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| +2 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| +1 | K120360 | Ortho Solutions Trauma Plates for Osteosysnthesis | Ortho Solutions Limited | 2012 | — |
| +3 | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021 | — |
| +2 | K202764 | Ortho Solutions Plating System | Ortho Solutions UK, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 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? (4)
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 |
|---|---|---|---|
| * | K083654 | Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V…Summary page 1…hreaded metallic bone fixation fastener Product Code: HTY - Pin, Fixation, Smooth Trade name: Mahe Fixation Plate and Screw System Predicate Devices: > K083654 & K082527 - Zimmerg Universal Locking System: 2.7 mm and 3.5 mm Locking Plates and Screws (Tivanium® Ti-6A1-4V Alloy, CP Grade Ti… | 2009 |
| * | K082527 | Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsSummary page 1…tallic bone fixation fastener Product Code: HTY - Pin, Fixation, Smooth Trade name: Mahe Fixation Plate and Screw System Predicate Devices: > K083654 & K082527 - Zimmerg Universal Locking System: 2.7 mm and 3.5 mm Locking Plates and Screws (Tivanium® Ti-6A1-4V Alloy, CP Grade Titanium) -… | 2008 |
| * | K091614 | Osteomed Foot Plating SystemSummary page 1…ices: > K083654 & K082527 - Zimmerg Universal Locking System: 2.7 mm and 3.5 mm Locking Plates and Screws (Tivanium® Ti-6A1-4V Alloy, CP Grade Titanium) - Zimmer, Inc. "K091614 - OisteoMed Foot Plate and Screw Rigid Fixation System - OsteoMed L. P. "K083912 - Treu Bone Fixation Screws and Pins - Treu Ins… | 2009 |
| * | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsSummary page 1…cking Plates and Screws (Tivanium® Ti-6A1-4V Alloy, CP Grade Titanium) - Zimmer, Inc. "K091614 - OisteoMed Foot Plate and Screw Rigid Fixation System - OsteoMed L. P. "K083912 - Treu Bone Fixation Screws and Pins - Treu Instrumente GmbH 1/3 === Pag… | 2009 |
What descends from it? (8)
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 15 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 41 ancestors have a recall of any class.
- Of its descendants, K172943 (Intrafuse, LLC, 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K083654.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Mahe Fixation Plate and Screw System is indicated for fracture fixation and joint fusion in the pelvis, small bones and long bones. Examples include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle hand and middle foot bones; and treatment of the calcaneus. The system is indicated for use in adult patients. All implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102845: Mahe Fixation Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102845
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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