510(k) · Cleared
ClearedSkeletal Dynamics Forearm Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 1, 2020 as substantially equivalent to K102998 (Acumed, LLC, 2011) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Jun 1, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K962616 (1996). 20 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK060864 Multidirectional Threaded PegHand Innovations, LLC · 2006
- 1 generation backK122737 Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC · 2012
- This deviceK200538 Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK242055 Freefix Forearm Plating SystemSkeletal Dynamics, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K060864 | Multidirectional Threaded Peg | Hand Innovations, LLC | 2006 | — |
| −1 | K122737 | Geminus Fossa Specific Plate System | Skeletal Dynamics, LLC | 2012 | — |
| 0 (this device) | K200538 | Skeletal Dynamics Forearm Plating System | Skeletal Dynamics, Inc. | 2020 | — |
| +1 | K242055 | Freefix Forearm Plating System | Skeletal Dynamics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K102998 | Congruent Bone Plate SystemSummary page 4…21 CFR §888.3030 Regulatory Class: Class II Product Code: HRS Predicate Devices Primary Predicate: Acumed, LLC, Congruent Bone Plate System, K102998, 01/04/2011 Additional Predicate: Skeletal Dynamics, GEMINUS Plate System K122737, 10/03/2012 Device Description The Skeletal… | 2011 |
| * | K122737 | Geminus Fossa Specific Plate SystemSummary page 4…HRS Predicate Devices Primary Predicate: Acumed, LLC, Congruent Bone Plate System, K102998, 01/04/2011 Additional Predicate: Skeletal Dynamics, GEMINUS Plate System K122737, 10/03/2012 Device Description The Skeletal Dynamics Forearm Plating System include Midshaft Radius Plates and Midshaft Ulna… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242055 | Freefix Forearm Plating System | 2024 | 0 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K242055 (Skeletal Dynamics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K102998.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Skeletal Dynamics Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200538 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200538: Skeletal Dynamics Forearm Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200538
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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