510(k) · Cleared
ClearedMDS Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miami Device Solutions, LLC · HRS Plate, Fixation, Bone
Cleared on Dec 8, 2017 as substantially equivalent to K143394 (Acumed, LLC, 2015) and 7 other predicates after an 84-day review. Its family tree reaches back 12 generations to 1979.
- Decided
- Dec 8, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 12 generations to K792022 (1979). 175 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations between
- 3 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 2 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 1 generation backK140769 Variax 2 SystemStryker Trauma AG · 2014
- This deviceK172786 MDS Plating SystemMiami Device Solutions, LLC · 2017
Show all 12 generations
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 6 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 5 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 4 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 3 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 2 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 1 generation backK140769 Variax 2 SystemStryker Trauma AG · 2014
- This deviceK172786 MDS Plating SystemMiami Device Solutions, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −11 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −10 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −9 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −8 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −7 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −6 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −5 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −4 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −3 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −2 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −1 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| 0 (this device) | K172786 | MDS Plating System | Miami Device Solutions, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 17 | 0 |
| 1997 | 5 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 15 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 13 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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? (8)
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 |
|---|---|---|---|
| * | K143394 | Acumed Small Fragment Base SetSummary page 4…condary: 21 CFR section 888.3040 – Smooth or threaded metallic bone fixation fastener Predicate Device: Primary K143394 Acumed Small Fragment Base Set K161292/ Miami Device Solutions Distal… | 2015 |
| * | K161292 | Distal Radius Plating SystemSummary page 4…bone fixation fastener Predicate Device: Primary K143394 Acumed Small Fragment Base Set K161292/ Miami Device Solutions Distal Secondary K162635 Radius… | 2016 |
| * | K162635 | Distal Radius Plating SystemSummary page 4…ase Set K161292/ Miami Device Solutions Distal Secondary K162635 Radius Plating System Secondary K162898 Miami Device Solutions Olecranon… | 2016 |
| * | K162898 | Olecranon Plating SystemSummary page 4…olutions Distal Secondary K162635 Radius Plating System Secondary K162898 Miami Device Solutions Olecranon K172786… | 2017 |
| * | K141493 | Proximal Humerus Plating SystemSummary page 5…ting System Miami Device Solutions Proximal Secondary K141493 Humerus Plating System… | 2015 |
| * | K992891 | Synthes Cerclage Positioning PinSummary page 5…econdary K141493 Humerus Plating System Secondary K992891 Synthes Cerclage Positioning Pin K132502,… | 1999 |
| * | K132502 | Variax 2 SystemSummary page 5…ng System Secondary K992891 Synthes Cerclage Positioning Pin K132502, Secondary Variax 2 System Bone Screws… | 2013 |
| * | K140769 | Variax 2 SystemSummary page 5…K132502, Secondary Variax 2 System Bone Screws K140769 Reference Devices: Paragon 28, Inc.; The Monster Screw System: Instrument… | 2014 |
| † | K151418 | Monster Screw System | 2015 |
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 38 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- 33 of the 175 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143394.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MDS Plating System is intended for internal fixation of fractures of various bones such as the clavicle, olecranon, humerus, radius, ulna, distal tibia, and fibula and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage cable of material compatible with system implants including titanium alloy and cobalt chromium.
The Low Profile Head Screw is used independently and is intended for internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.
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/K172786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172786: MDS Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172786
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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