510(k) · Cleared
ClearedSmith & Nephew, Inc Screw and Plate System Instrumentation
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 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.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- This deviceK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 9 of its ownK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 1 generation backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −2 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −1 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| 0 (this device) | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +1 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +2 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K181533 | EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K193623 | FDA’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)… | 2020 |
| * | K952697 | Titanium Classic Compression Hip Screw SystemSummary 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… | 1995 |
| * | K973098 | Compression Cerclage Gundolf CCG-GFSummary 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 (… | 1997 |
| * | K993106 | Smith & 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)… | 1999 |
| * | K011719 | Plus Cancellous Bone ScrewsSummary 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… | 2001 |
| Kept off the family tree | K103669 | Smith & 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 | |
| * | K050849 | HA Coated Lag ScrewSummary 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.… | 2005 |
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary 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… | 2005 |
| * | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSummary 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… | 2006 |
| * | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySummary 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… | 2006 |
| * | K071563 | Peri-Loc Periarticular Locked Plating SystemSummary 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)… | 2007 |
| * | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSummary 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… | 2007 |
| * | K080434 | Intertan CHS Locking Plate System Prox Fem Plates/ScrewSummary 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)… | 2008 |
| * | K081106 | Peri-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… | 2008 |
| * | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSummary 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… | 2008 |
| * | K083032 | Peri-Loc Bone Plating and Screw SystemSummary 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… | 2009 |
| * | K090656 | Intertan CHS Limited Collapse Set ScrewSummary 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… | 2009 |
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary 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… | 2009 |
| * | K092015 | Peri-Loc Periarticular Locked Plating SystemSummary 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… | 2009 |
| * | K100325 | Peri-Loc Locking Hole Inserts and Cable AccessoriesSummary 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… | 2010 |
What descends from it? (33)
See all 333 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)
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 devicesHRS 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
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?
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.
https://510kreport.com/device/K123055 · printed Nov 6, 2026
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