510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew, Inc Screw and Plate System Instrumentation

K123055510(k) TraditionalCleared Jan 25, 2013116-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · HRS Plate, Fixation, Bone

Cleared on Jan 25, 2013 as substantially equivalent to K952697 (Smith & Nephew Richards, Inc., 1995) and 17 other predicates after a 116-day review. Its family tree reaches back 10 generations to 1996. 33 later devices descend from it.

Decided
Jan 25, 2013
Review
116 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
20

Its longest line of descent runs back 10 generations to K962616 (1996). 90 ancestors in all, the oldest K792022 (1979). 33 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 3 other ancestors2008: 2 other ancestors2007: 3 other ancestors2006: 3 other ancestors2005: 4 other ancestors2001: 10 other ancestors1999: 4 other ancestors1997: 5 other ancestors1995: 7 other ancestors2004: 5 other ancestors2003: 3 other ancestors2000: 9 other ancestors1996: 5 other ancestors1990: 2 other ancestors1982: 1 other ancestor2002: 2 other ancestors1998: 5 other ancestors1991: 1 other ancestor1989: 1 other ancestor1994: 1 other ancestor1993: 2 other ancestors1979: 1 other ancestor2014: 1 descendant cleared2022: 4 descendants cleared2021: 2 descendants cleared2024: 7 descendants cleared2025: 7 descendants cleared2018: 3 descendants cleared2017: 2 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2020: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006×2: 2 generations cleared close together, K082516 (2008), K083032 (2009) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 30 other ancestors3 generations back: 21 other ancestors4 generations back: 13 other ancestors6 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 14 descendants3 generations forward: 10 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants K083032 · Peri-Loc Bone Plating and Screw System · Smith & Nephew, Inc. · 2009 · recalledK082516 · Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws · Smith & Nephew, Inc. · 2008K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50+5
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations between
  3. 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  4. 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  5. 1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  6. This deviceK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  7. Descendant · cites it directly · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  8. Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  9. Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
  10. Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
  11. Descendant · 2 generations on · 9 of its ownK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
Show all 10 generations
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  11. This deviceK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2014: 12017: 22018: 32020: 12021: 22022: 42023: 32024: 72025: 72026: 3
2014high 7 (2024) · low 0 (2015)2026

Most influential descendants

Showing 5 of 33 · See all
  • K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · cites it directly32descendants
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
  • K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
  • K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018 · 2 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−9K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−8K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−7K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−4K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−3K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−2K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−1K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
0 (this device)K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
+1K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.2018—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198910
199020
199110
199320
199410
199570
199650
199750
199850
199940
200090
2001100
200220
200330
200450
200540
200630
200730
200820
200930
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201720
201830
202010
202120
202240
202330
202470
202570
202630
FIG. 1 — Lineage of K123055, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (20)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK193623FDA’s K193623 is DIOnavi-Denture
Our reading of the summary gave K193623, which FDA decided on Oct 22, 2020, after this device was decided (Jan 25, 2013), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree.
Summary page 1
…21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Pelvic Radius Plate K1936233) Titanium Classic Compression Hip Screw System (K(952697) Compression Cerclage Gundolf CCF-GF K1973098)…
Dio Corporation2020—
*K952697Titanium Classic Compression Hip Screw System
Summary page 1
…ener Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Pelvic Radius Plate K1936233) Titanium Classic Compression Hip Screw System (K(952697) Compression Cerclage Gundolf CCF-GF K1973098) Smith & Nephew Bone Plate System (Bone Plates and Screws & Accesso…
Smith & Nephew Richards, Inc.1995—
*K973098Compression Cerclage Gundolf CCG-GF
Summary page 1
…7 Predicate Devices: Pelvic Radius Plate K1936233) Titanium Classic Compression Hip Screw System (K(952697) Compression Cerclage Gundolf CCF-GF K1973098) Smith & Nephew Bone Plate System (Bone Plates and Screws & Accessories) (K(993106) PLUS Cancellous Bone Screws (…
Plus Orthopedics1997—
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 1
…sion Hip Screw System (K(952697) Compression Cerclage Gundolf CCF-GF K1973098) Smith & Nephew Bone Plate System (Bone Plates and Screws & Accessories) (K(993106) PLUS Cancellous Bone Screws (K011719) Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)…
Smith & Nephew, Inc.1999—
*K011719Plus Cancellous Bone Screws
Summary page 1
…ression Cerclage Gundolf CCF-GF K1973098) Smith & Nephew Bone Plate System (Bone Plates and Screws & Accessories) (K(993106) PLUS Cancellous Bone Screws (K011719) Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) K1033669) HA Coated Lag Screw K1050849…
Plus Orthopedics2001—
Kept off the family treeK103669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*K050849HA Coated Lag Screw
Summary page 1
…) PLUS Cancellous Bone Screws (K011719) Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) K1033669) HA Coated Lag Screw K1050849) PERI-LOC Locking Bone Plates and Locking Bone Screws for the Upper Extremity K1051735) Smith & Nephew 6.…
Smith & Nephew, Inc.2005—
*K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Summary page 1
…ng Bone Plates and Screws) K1033669) HA Coated Lag Screw K1050849) PERI-LOC Locking Bone Plates and Locking Bone Screws for the Upper Extremity K1051735) Smith & Nephew 6.5MM and 8.0MM Cannulated Screws (K(060736) PERI-LOC Periarticular Locked Plating System for the…
Smith & Nephew, Inc.2005—
*K060736Smith & Nephew 6.5MM and 8.0MM Cannulated Screws
Summary page 1
…50849) PERI-LOC Locking Bone Plates and Locking Bone Screws for the Upper Extremity K1051735) Smith & Nephew 6.5MM and 8.0MM Cannulated Screws (K(060736) PERI-LOC Periarticular Locked Plating System for the Upper Extremity (K(061352) PERI-LOC Periarticular Locked Pl…
Smith & Nephew, Inc.20061
*K061352Peri-Loc Periarticular Locked Plating System for the Upper Extremity
Summary page 1
…ity K1051735) Smith & Nephew 6.5MM and 8.0MM Cannulated Screws (K(060736) PERI-LOC Periarticular Locked Plating System for the Upper Extremity (K(061352) PERI-LOC Periarticular Locked Plating System (1(071563) PERI-LOC Periarticular Locked Plating System - Proximal…
Smith & Nephew, Inc.2006—
*K071563Peri-Loc Periarticular Locked Plating System
Summary page 1
…nulated Screws (K(060736) PERI-LOC Periarticular Locked Plating System for the Upper Extremity (K(061352) PERI-LOC Periarticular Locked Plating System (1(071563) PERI-LOC Periarticular Locked Plating System - Proximal Femoral Plates/Screws, Cable Accessories (1072818)…
Smith & Nephew, Inc.2007—
*K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access
Summary page 1
…ERI-LOC Periarticular Locked Plating System (1(071563) PERI-LOC Periarticular Locked Plating System - Proximal Femoral Plates/Screws, Cable Accessories (1072818) INTERTAN CHS Locking Plate System Proximal Femoral Plates/Screw (K(080434) PERI-LOC Periarticular Locked Plating…
Smith & Nephew, Inc.2007—
*K080434Intertan CHS Locking Plate System Prox Fem Plates/Screw
Summary page 1
…ar Locked Plating System - Proximal Femoral Plates/Screws, Cable Accessories (1072818) INTERTAN CHS Locking Plate System Proximal Femoral Plates/Screw (K(080434) PERI-LOC Periarticular Locked Plating System Volar Distal Radius Locking Plate for the Upper Extremity K1081106)…
Smith & Nephew, Inc.2008—
*K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…
Summary page 1
…System Proximal Femoral Plates/Screw (K(080434) PERI-LOC Periarticular Locked Plating System Volar Distal Radius Locking Plate for the Upper Extremity K1081106) PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws (1(082516) PERI-LOC Bone Plating and Screw…
Smith & Nephew, Inc.2008—
*K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws
Summary page 1
…lating System Volar Distal Radius Locking Plate for the Upper Extremity K1081106) PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws (1(082516) PERI-LOC Bone Plating and Screw System K1083032) INTERTAN CHS Limited Collapse Set Screw (1090656) Smith…
Smith & Nephew, Inc.2008—
*K083032Peri-Loc Bone Plating and Screw System
Summary page 1
…Upper Extremity K1081106) PERI-LOC Periarticular Locked Plating System Hexalobular Bone Screws (1(082516) PERI-LOC Bone Plating and Screw System K1083032) INTERTAN CHS Limited Collapse Set Screw (1090656) Smith & Nephew VLP Foot Plating, Screw System &Accessories (K0…
Smith & Nephew, Inc.20092
*K090656Intertan CHS Limited Collapse Set Screw
Summary page 1
…cular Locked Plating System Hexalobular Bone Screws (1(082516) PERI-LOC Bone Plating and Screw System K1083032) INTERTAN CHS Limited Collapse Set Screw (1090656) Smith & Nephew VLP Foot Plating, Screw System &Accessories (K090675) PERI-LOC Periarticular Locked Plating Syste…
Smith & Nephew, Inc.2009—
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 1
…LOC Bone Plating and Screw System K1083032) INTERTAN CHS Limited Collapse Set Screw (1090656) Smith & Nephew VLP Foot Plating, Screw System &Accessories (K090675) PERI-LOC Periarticular Locked Plating System (1(092015) PERI-LOC Locking Hole Inserts and Cable Accessories 1003…
Smith & Nephew, Inc.2009—
*K092015Peri-Loc Periarticular Locked Plating System
Summary page 1
…Limited Collapse Set Screw (1090656) Smith & Nephew VLP Foot Plating, Screw System &Accessories (K090675) PERI-LOC Periarticular Locked Plating System (1(092015) PERI-LOC Locking Hole Inserts and Cable Accessories 100325) Summary of Satfety and Effectiveness…
Smith & Nephew, Inc.20091
*K100325Peri-Loc Locking Hole Inserts and Cable Accessories
Summary page 1
…Plating, Screw System &Accessories (K090675) PERI-LOC Periarticular Locked Plating System (1(092015) PERI-LOC Locking Hole Inserts and Cable Accessories 100325) Summary of Satfety and Effectiveness i23 6 p5 Z/5' Plate and Scre…
Smith & Nephew, Inc.2010—

Also cleared against K952697: 3 other devices →

What descends from it? (33)

See all 33

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.201432
K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20217
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.20222

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 17 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 20 of the 90 ancestors have a recall of any class.
  • Of its descendants, K140814 (Smith & Nephew, Inc., 2014) has gone furthest, with 32 descendants of its own.
  • 3 other devices also cite its predicate K952697.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use. The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients…

Read the full statement (934 words)

Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use.

The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. The PERI-LOC Proximal Femur Locking Bone Plates, Bone Screws, Locking Hole Inserts 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 the 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

* subtrochanteric femur fractures.

In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and 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.

Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use.

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 Plating System is indicated for:

* the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.

The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for:

* fixation of interarticular and extra-articular fractures and non-unions of small bones and small bone fragments;

* arthrodesis 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 OFX 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.

Smith & Nephew Accessories, such as pins and wires, are indicated for:

* pelvic, small and long bone fracture fixation.

Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use.

InterTAN CHS Limited Collapse Set Screw is indicated for:

* Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).

* Intertrochanteric fractures.

* Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.

* Hip osteotomy

Smith & Nephew VLP Locking Bone Plates and Locking/Non-Locking Bone Screws Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use.

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:

* fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use.

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for:

* fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones;

* treatment of the calcaneal

* hip arthrodesis

* provisional bone fixation.

Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Bone Plate Systems and their cleared indications for use.

Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for:

* pelvic fracture fixation

* small bone fracture fixation

* long bone fracture fixation.

Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use.

The Titanium Classic Compression Hip Screw System is indicated for:

* Pelvic Radius Plate- general fractures of the pelvis and acetabulum

* Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement

* One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, metatarsals, olecranon, and distal ulna

* Small Auto-Compression Plate- fracture fixation of metatarsals, metacarpals, radius, and ulna

* Titanium Cortical Bone Screw- small and long bone fracture fixation

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123055

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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