510(k) · Cleared
ClearedProtean Fragment 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 Sep 26, 2024 as substantially equivalent to K150099 (Synthes (USA) Products, LLC, 2015) and 3 other predicates after a 94-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- Sep 26, 2024
- Review
- 94 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K962616 (1996). 297 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 2 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 1 generation backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- This deviceK241815 Protean Fragment Plating SystemSkeletal Dynamics, Inc. · 2024
Show all 17 generations
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 16 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 15 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 14 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 13 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 11 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 10 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 9 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 8 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 7 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 6 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 5 generations backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- 4 generations backK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- 3 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 2 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 1 generation backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- This deviceK241815 Protean Fragment Plating SystemSkeletal Dynamics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −16 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −15 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −14 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −13 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −11 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −10 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −9 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −8 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −7 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −6 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −5 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| −4 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| −3 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| −2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| −1 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| 0 (this device) | K241815 | Protean Fragment Plating System | Skeletal Dynamics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 13 | 0 |
| 1996 | 20 | 0 |
| 1997 | 11 | 0 |
| 1998 | 12 | 0 |
| 1999 | 11 | 0 |
| 2000 | 15 | 0 |
| 2001 | 23 | 0 |
| 2002 | 9 | 0 |
| 2003 | 16 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 16 | 0 |
| 2007 | 11 | 0 |
| 2008 | 13 | 0 |
| 2009 | 12 | 0 |
| 2010 | 11 | 0 |
| 2011 | 10 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Summary page 5…ry Class: Class II. Product Code: HRS, HWC Predicate Devices: Primary Predicate: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) (K150099). Additional Predicates: • Synthes Cortical Screws (K112583) • ANTHEM® Fracture System (K212433) • Protean Fragment Plating Syste… | 2015 |
| * | K112583 | Synthes Cortical ScrewsSummary page 5…s: Primary Predicate: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) (K150099). Additional Predicates: • Synthes Cortical Screws (K112583) • ANTHEM® Fracture System (K212433) • Protean Fragment Plating System (K140372) Device Description: The Skeletal Dynamics Prote… | 2011 |
| * | K212433 | Anthem Fracture SystemSummary page 5…Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) (K150099). Additional Predicates: • Synthes Cortical Screws (K112583) • ANTHEM® Fracture System (K212433) • Protean Fragment Plating System (K140372) Device Description: The Skeletal Dynamics Protean Fragment Plating System is a set… | 2021 |
| * | K140372 | Fragment Plate SystemSummary page 5…nd 2.0 mm Plates and Screws) (K150099). Additional Predicates: • Synthes Cortical Screws (K112583) • ANTHEM® Fracture System (K212433) • Protean Fragment Plating System (K140372) Device Description: The Skeletal Dynamics Protean Fragment Plating System is a set of medical-grade Titanium Alloy (Ti-6Al-4V E… | 2014 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 51 of the 297 ancestors have a recall of any class.
- 5 other devices also cite its predicate K150099.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Protean Fragment Plating System is intended for stabilization and fixation in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, clavicle, scapula, finger, toe, and pelvis, particularly in osteopenic bone with the appropriate configuration of the device. The system is intended for use in adult and pediatric populations (children and adolescents).
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/K241815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241815: Protean Fragment 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/K241815
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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