510(k) · Cleared
ClearedStratum® Ankle Fusion Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 18, 2021 as substantially equivalent to K182148 (Paragon 28, Inc., 2018) and 2 other predicates after a 90-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Nov 18, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K954385 (1996). 230 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations between
- 3 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 2 generations backK172886 Breakaway Screw SystemParagon 28 · 2017
- 1 generation backK182148 SILVERBACK Gorilla Plating SystemParagon 28, Inc. · 2018
- This deviceK212640 Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021
Show all 15 generations
- Root · 15 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 13 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 12 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 11 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 10 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 9 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 8 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 7 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 6 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 5 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 4 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 2 generations backK172886 Breakaway Screw SystemParagon 28 · 2017
- 1 generation backK182148 SILVERBACK Gorilla Plating SystemParagon 28, Inc. · 2018
- This deviceK212640 Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −14 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −13 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −12 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −11 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −10 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −9 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −8 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −7 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −6 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −5 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −4 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −2 | K172886 | Breakaway Screw System | Paragon 28 | 2017 | — |
| −1 | K182148 | SILVERBACK Gorilla Plating System | Paragon 28, Inc. | 2018 | — |
| 0 (this device) | K212640 | Stratum® Ankle Fusion Plating System | Nextremity Solutions, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 15 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 21 | 0 |
| 2002 | 18 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 17 | 0 |
| 2006 | 14 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K182148 | SILVERBACK Gorilla Plating SystemSummary page 4…(Primary), HWC Substantially Equivalent Devices: • Paragon 28® SilverbackTM Ankle Fusion Plating System(Cleared as Silverback Gorilla Plating System), K182148-Primary Predicate • Zimmer Biomet Ankle Fix System 4.0(Cleared as Normed Medizin-Technik GmbH ANKLE FIX and ANKLE… | 2018 |
| * | K123347 | Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Summary page 4…System), K182148-Primary Predicate • Zimmer Biomet Ankle Fix System 4.0(Cleared as Normed Medizin-Technik GmbH ANKLE FIX and ANKLE FIX PLUS Systems 4.0), K123347-Additional Predicate • Nextremity Solutions Stratum Foot Plating System, K182201-Additional Predicate Device Description:… | 2013 |
| * | K182201 | Stratum™ Foot Plating SystemSummary page 4…s Normed Medizin-Technik GmbH ANKLE FIX and ANKLE FIX PLUS Systems 4.0), K123347-Additional Predicate • Nextremity Solutions Stratum Foot Plating System, K182201-Additional Predicate Device Description: The Stratum Ankle Fusion Plating System is a foot and ankle plating system consisting of… | 2018 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 47 of the 230 ancestors have a recall of any class.
- 1 other device also cites its predicate K182148.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Stratum Ankle Fusion Plating System is indicated for use in stabilization and fixation of fractures or osteotomies, intra and extra articular fractures, and multi-fragmentary fractures, revision procedures, non-union and malunion, joint fusion and reconstruction of small bones of the feet and ankles including the distal tibia, talus, and calcaneus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212640: Stratum® Ankle Fusion 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/K212640
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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