510(k) · Cleared
Recalled · 2026EVOS Small Fragment Lower Extremity Plates
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 Jun 14, 2017 as substantially equivalent to K993106 (Smith & Nephew, Inc., 1999) and 1 other predicate after a 119-day review. Its family tree reaches back 8 generations to 1996. 13 later devices descend from it. It has been recalled once.
- Decided
- Jun 14, 2017
- Review
- 119 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K962616 (1996). 30 ancestors in all, the oldest K890939 (1989). 13 later devices descend from it, 3 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 backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- This deviceK170457 EVOS Small Fragment Lower Extremity PlatesSmith & 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 · 2 generations on · 8 of its ownK201527 EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc. · 2020
- Descendant · cites it directly · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- 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
- K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc. · 2020 · 2 generations on8descendants
- K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · cites it directly7descendants
- K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · cites it directly2descendants
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 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K170457 | EVOS Small Fragment Lower Extremity Plates | 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 | — |
| +2 | K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) | Smith & Nephew, Inc. | 2020 | — |
| +1 | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | 1 |
| +1 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 4…Nephew Bone Plate December 9, Smith & Nephew, Inc. System (primary predicate, K993106 1999 now branded as TC-100… | 1999 |
| * | K071563 | Peri-Loc Periarticular Locked Plating SystemSummary page 4…VLP, reference predicate) PERI-LOC Periarticular Locked Smith & Nephew, Inc. Plating System – VLP Locking K071563 August 8, 2007 Bone Plates and Screws EVOS Small Fragment Plating… | 2007 |
| † | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | 2003 |
| † | K062216 | Peri-Loc Periarticular Locked Plating System | 2006 |
| † | K162078 | EVOS Small Fragment Plating System | 2016 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2026 | Not classified | Z-0318-2027 | Labeling Change Control | Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 30 ancestors have a recall of any class.
- Of its descendants, K173293 (Smith & Nephew, Inc., 2018) has gone furthest, with 12 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. 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 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.
The EVOS Partial Articular and Anti-Glide plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classification Type B), and for fracture fixation of the fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170457: EVOS Small Fragment Lower Extremity Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170457
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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