510(k) · Cleared
Recalled · Class II · 2021EVOS Small Fragment Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 18, 2016 as substantially equivalent to K993106 (Smith & Nephew, Inc., 1999) and 4 other predicates after a 114-day review. Its family tree reaches back 9 generations to 1996. 26 later devices descend from it. It has been recalled once.
- Decided
- Nov 18, 2016
- Review
- 114 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 9 generations to K962616 (1996). 32 ancestors in all, the oldest K890939 (1989). 26 later devices descend from it, 9 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- This deviceK162078 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2016
- Descendant · cites it directly · 13 of its ownK170887 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017
- Descendant · cites it directly · 12 of its ownK173293 EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018
- Descendant · 2 generations on · 9 of its ownK190253 EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc. · 2019
- Descendant · cites it directly · 9 of its ownK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK172262 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- This deviceK162078 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2016
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017 · cites it directly13descendants
- K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018 · cites it directly12descendants
- K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc. · 2019 · 2 generations on9descendants
- K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018 · cites it directly9descendants
- K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −1 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K162078 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | 2016 | — |
| +1 | K170887 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | 2017 | — |
| +1 | K173293 | EVOS Small Fragment Upper Extremity Plates | Smith & Nephew, Inc. | 2018 | — |
| +2 | K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions | Smith & Nephew, Inc. | 2019 | — |
| +1 | K181533 | EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. | 2018 | — |
| +1 | K172262 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | 2017 | — |
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 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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? (5)
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 |
|---|---|---|---|
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 4…ew Bone Plate December 9, Smith & Nephew, Inc. System (primary predicate, K993106 1999 now branded as T… | 1999 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…999 now branded as TC-100) Synthes Small Fragment Synthes (USA) Dynamic Compression Locking K000684 April 28, 2000 System Smith & Nephew Locking Bone… | 2000 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 4…Locking Bone December 10, Smith & Nephew, Inc. Plate System (now branded as K033669 2003 PERI-LOC)… | 2003 |
| * | K062216 | Peri-Loc Periarticular Locked Plating SystemSummary page 4…ular Locked September 15, Smith & Nephew, Inc. Plating System – B Plate Locking K062216 2006 Bone Plates and… | 2006 |
| * | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSummary page 4…ular Locked September 17, Smith & Nephew, Inc. Plating System Hexalobular Bone K082516 2008 Screws Device D… | 2008 |
What descends from it? (26)
See all 269 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170887 | EVOS Small Fragment Plating System | 2017 | 13 |
| K173293 | EVOS Small Fragment Upper Extremity Plates | 2018 | 12 |
| K181533 | EVOS Wrist Fracture Plating System | 2018 | 9 |
| K172262 | EVOS Small Fragment Plating System | 2017 | 9 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
| K201918 | EVOS Large Fragment Plating System | 2020 | 4 |
| K203405 | EVOS Large Fragment Plating System | 2021 | 3 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP… | 2022 | 2 |
| K241666 | EVOS Pelvic and Acetabular System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2021 | Class II | Z-0265-2022 | Error in labeling | The labels on the packages of screws were switched. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 32 ancestors have a recall of any class.
- Of its descendants, K170887 (Smith & Nephew, Inc., 2017) has gone furthest, with 13 descendants of its own.
- 35 other devices also cite its predicate K993106.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 EVOS Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
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/K162078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162078: EVOS Small 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/K162078
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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