510(k) · Cleared
ClearedEVOS Small Fragment Upper 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 Jan 8, 2018 as substantially equivalent to K993106 (Smith & Nephew, Inc., 1999) and 6 other predicates after an 84-day review. Its family tree reaches back 11 generations to 1996. 12 later devices descend from it.
- Decided
- Jan 8, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K962616 (1996). 45 ancestors in all, the oldest K890939 (1989). 12 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 2 generations backK100325 Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010
- 1 generation backK170887 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017
- This deviceK173293 EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018
- Descendant · cites it directly · 9 of its ownK190253 EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc. · 2019
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 3 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 2 generations backK100325 Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc. · 2010
- 1 generation backK170887 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017
- This deviceK173293 EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc. · 2019 · cites it directly9descendants
- K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc. · 2020 · cites it directly8descendants
- 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
- K233017TM Plating SystemTyber Medical, LLC · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −3 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −2 | K100325 | Peri-Loc Locking Hole Inserts and Cable Accessories | Smith & Nephew, Inc. | 2010 | — |
| −1 | K170887 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | 2017 | — |
| 0 (this device) | K173293 | EVOS Small Fragment Upper Extremity Plates | Smith & Nephew, Inc. | 2018 | — |
| +1 | K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions | Smith & Nephew, Inc. | 2019 | — |
| +1 | 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 |
| +2 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 4…ephew 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…iarticular Locked Plating System – B Plate Locking September 15, Smith & Nephew, Inc. K062216 Bone Plates and Screws (now 2006 branded as PERI-LOC V… | 2006 |
| * | K071563 | Peri-Loc Periarticular Locked Plating SystemSummary page 4…6 branded as PERI-LOC VLP) PERI-LOC Periarticular Locked Smith & Nephew, Inc. Plating System –VLP Locking K071563 August 8, 2007 Bone Plates and Screws EVOS Small Fragment Plating… | 2007 |
| * | K162078 | EVOS Small Fragment Plating SystemSummary page 4…l Fragment Plating November 18, Smith & Nephew, Inc. System Straight Plates and K162078 2016 Screws… | 2016 |
| * | K170457 | EVOS Small Fragment Lower Extremity PlatesSummary page 4…2016 Screws EVOS Small Fragment Lower Smith & Nephew, Inc. K170457 June 14, 2017 Extremity Plates EVOS Small Fragment Plating Smith & N… | 2017 |
| * | K170887 | EVOS Small Fragment Plating SystemSummary page 4…ne 14, 2017 Extremity Plates EVOS Small Fragment Plating Smith & Nephew, Inc. K170887 April 24, 2017 System… | 2017 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions | 2019 | 9 |
| K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) | 2020 | 8 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
| 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)
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 22 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 45 ancestors have a recall of any class.
- Of its descendants, K190253 (Smith & Nephew, Inc., 2019) has gone furthest, with 9 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. 2018, 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/K173293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173293: EVOS Small Fragment Upper 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/K173293
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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