510(k) · Cleared
Recalled · 2026Smith & Nephew Plates and Screws
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 29, 2021 as substantially equivalent to K201527 (Smith & Nephew, Inc., 2020) and 37 other predicates after a 99-day review. Its family tree reaches back 13 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2021
- Review
- 99 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 38
Its longest line of descent runs back 13 generations to K962616 (1996). 211 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 2 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 1 generation backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
- This deviceK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
- Descendant · cites it directly · 0 of its ownK253713 Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 5 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 4 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 3 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 2 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 1 generation backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
- This deviceK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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 · cites it directly1descendant
- K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · 2 generations on0descendants
- K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026 · cites it directly0descendants
- K252019CurvaFix Low Profile SystemCurvafix, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −5 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −4 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −3 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −2 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −1 | K181533 | EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. | 2018 | — |
| 0 (this device) | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | — |
| +1 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| +1 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
| +2 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | — |
| +1 | K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | 2026 | — |
| +2 | K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 5 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 18 | 0 |
| 2002 | 18 | 0 |
| 2003 | 6 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 12 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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? (38)
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 |
|---|---|---|---|
| * | K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Summary page 11…JDO, KTT, HRS, HWC, HTN, NDG, HTY Predicate Device: Smith & Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP… | 2020 |
| * | K120667 | VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Summary page 11…TT, HRS, HWC, HTN, NDG, HTY Predicate Device: Smith & Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K15… | 2012 |
| * | K161665 | VLP Wrist Fracture SystemSummary page 11…Smith & Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw… | 2016 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 11…Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (… | 1999 |
| * | K152976 | VLP Mini-Mod Talus PlatesSummary page 11…EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029),… | 2015 |
| * | K993289 | Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw SystemSummary page 11…), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029), and cannulated screws (K133662) Device Description The purpose o… | 1999 |
| * | K193029 | Conquest FNSummary page 11…, TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029), and cannulated screws (K133662) Device Description The purpose of this Traditional 510(… | 2020 |
| * | K133662 | Smith & Nephew Cannulated Captured ScrewSummary page 11…(K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029), and cannulated screws (K133662) Device Description The purpose of this Traditional 510(k) is to add the MR safety information to the labeling, and update the… | 2014 |
| * | K952697 | Titanium Classic Compression Hip Screw SystemSummary page 15…tion Clearance Date Number Smith & Nephew K952697 09/12/1995 Smith & Nephew, Compression Hip Screw K954712 10/31/1995 Inc.… | 1995 |
| * | K954712 | Intramedullary Hip Screw (Modification)Summary page 15…Number Smith & Nephew K952697 09/12/1995 Smith & Nephew, Compression Hip Screw K954712 10/31/1995 Inc. (CHS) K993289 12/20/1999 Table 5.2: Substantially… | 1995 |
| * | K152686 | Conquest FNSummary page 15…iption Clearance Date Number K152686 03/17/2016 Smith & Nephew, Smith & Nephew K172785 12/22… | 2016 |
| * | K172785 | Conquest FNSummary page 15…K152686 03/17/2016 Smith & Nephew, Smith & Nephew K172785 12/22/2017 Inc. CONQUEST FN System K193029 0… | 2017 |
| * | K132296 | D-Rad Smart PackSummary page 15…on Clearance Date Number Smith & Nephew, K132296 01/07/2014 D-Rad Plating System Inc. K161665… | 2014 |
| * | K140814 | Evos Mini-Fragment Plating SystemSummary page 15…ion Clearance Date Number K140814 05/07/2014 K162078 11/18/2016 Smith & Nephew,… | 2014 |
| * | K162078 | EVOS Small Fragment Plating SystemSummary page 15…Number K140814 05/07/2014 K162078 11/18/2016 Smith & Nephew, K170457 06/14/2017 Inc. EVOS P… | 2016 |
| * | K170457 | EVOS Small Fragment Lower Extremity PlatesSummary page 15…K140814 05/07/2014 K162078 11/18/2016 Smith & Nephew, K170457 06/14/2017 Inc. EVOS Plating System K170887 04/24/2017… | 2017 |
| * | K170887 | EVOS Small Fragment Plating SystemSummary page 15…K162078 11/18/2016 Smith & Nephew, K170457 06/14/2017 Inc. EVOS Plating System K170887 04/24/2017 K173293 01/08/2018… | 2017 |
| * | K173293 | EVOS Small Fragment Upper Extremity PlatesSummary page 15…K170457 06/14/2017 Inc. EVOS Plating System K170887 04/24/2017 K173293 01/08/2018 K181533 08/09/2018… | 2018 |
| * | K181533 | EVOS Wrist Fracture Plating SystemSummary page 15…K170887 04/24/2017 K173293 01/08/2018 K181533 08/09/2018 K210837 Page 5 of 6 ==… | 2018 |
| * | K190253 | EVOS Small Fragment Upper Extremity Plates Line AdditionsSummary page 16…K210837 Page 5 of 6 K190253 03/11/2019 K201527 07/22/2020 Table 5.5: Substantially Equiv… | 2019 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 16…ion Clearance Date Number K033669 12/10/2003 K051735 07/19/2005… | 2003 |
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary page 16…Number K033669 12/10/2003 K051735 07/19/2005 K061352 06/08/2006… | 2005 |
| * | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySummary page 16…K033669 12/10/2003 K051735 07/19/2005 K061352 06/08/2006 K062216 09/15/2006… | 2006 |
| * | K062216 | Peri-Loc Periarticular Locked Plating SystemSummary page 16…K051735 07/19/2005 K061352 06/08/2006 K062216 09/15/2006 K071563 08/08/2007… | 2006 |
| * | K071563 | Peri-Loc Periarticular Locked Plating SystemSummary page 16…K061352 06/08/2006 K062216 09/15/2006 K071563 08/08/2007 K072818 11/19/2007… | 2007 |
| * | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSummary page 16…K062216 09/15/2006 K071563 08/08/2007 K072818 11/19/2007 K080434 04/10/2008 Peri-Loc Per… | 2007 |
| * | K080434 | Intertan CHS Locking Plate System Prox Fem Plates/ScrewSummary page 16…K071563 08/08/2007 K072818 11/19/2007 K080434 04/10/2008 Peri-Loc Periarticular and K082516 09/17/2008 Smith & Nephew,… | 2008 |
| * | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSummary page 16…K072818 11/19/2007 K080434 04/10/2008 Peri-Loc Periarticular and K082516 09/17/2008 Smith & Nephew, Variable-Angled Locked Plating K083032 01/07/2009 Inc.… | 2008 |
| * | K083032 | Peri-Loc Bone Plating and Screw SystemSummary page 16…0434 04/10/2008 Peri-Loc Periarticular and K082516 09/17/2008 Smith & Nephew, Variable-Angled Locked Plating K083032 01/07/2009 Inc. (VLP) Systems K090675 06/04/2009… | 2009 |
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 16…09/17/2008 Smith & Nephew, Variable-Angled Locked Plating K083032 01/07/2009 Inc. (VLP) Systems K090675 06/04/2009 K092015 07/30/2009… | 2009 |
| * | K092015 | Peri-Loc Periarticular Locked Plating SystemSummary page 16…ing K083032 01/07/2009 Inc. (VLP) Systems K090675 06/04/2009 K092015 07/30/2009 K100325 05/04/2010… | 2009 |
| * | K100325 | Peri-Loc Locking Hole Inserts and Cable AccessoriesSummary page 16…K090675 06/04/2009 K092015 07/30/2009 K100325 05/04/2010 K110670 07/12/2011… | 2010 |
| * | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Summary page 16…K092015 07/30/2009 K100325 05/04/2010 K110670 07/12/2011 K120667 04/04/2012… | 2011 |
| * | K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSummary page 16…K110670 07/12/2011 K120667 04/04/2012 K132886 02/04/2014 K143050 12/18/2014… | 2014 |
| * | K143050 | VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSummary page 16…K120667 04/04/2012 K132886 02/04/2014 K143050 12/18/2014 K152976 11/12/2015 Table 5.6: Substantially Equivale… | 2014 |
| * | K123055 | Smith & Nephew, Inc Screw and Plate System InstrumentationSummary page 16…ion Clearance Date Number Smith & Nephew, TC-100 Screw and Plating K123055 01/25/2013 Inc. System K993106 12/09/1999 Table 5.7: Substantially Equivale… | 2013 |
| * | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSummary page 16…on Clearance Date Number K060736 04/18/2006 Smith & Nephew, Inc. Cannulated Screws K111994 10/11/2011… | 2006 |
| * | K111994 | Smith & Nephew Cannulated Screws and WashersSummary page 16…Number K060736 04/18/2006 Smith & Nephew, Inc. Cannulated Screws K111994 10/11/2011 K133662 5/15/2014 Conclusion In summary, the only… | 2011 |
What descends from it? (7)
4 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 25 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 41 of the 211 ancestors have a recall of any class.
- Of its descendants, K213126 (Smith & Nephew, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K201527.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Adult Indications 1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.) 2. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity. 3. Osteotomies for patients with diseases or…
Read the full statement (1,106 words)
Adult Indications
1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
2. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
3. Osteotomies for patients with diseases or deformities of the hip.
4. Hip arthrodesis.
5. Supracondylar fractures and distal femoral fractures using a supracondylar plate.
6. Ipsilateral femoral shaft/neck fractures.]
Pediatric Indications
1. Congenital coxa vara.
2. Congenital dislocation of the hip.
3. Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
4. Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.
CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius.
The EVOS MINI Plating System is indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) 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 Classifications Type B), and for fracture fixation of the fibula.
The EVOS Wrist Fracture Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
The PERI-LOC Plate and Screw System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and bone screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.
PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot.
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.
Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.
Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.
The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
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/K210837 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210837: Smith & Nephew Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210837
Report an extraction error
Are you the manufacturer?
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