510(k) · Cleared
Recalled · Class II · 2021Smith & Nephew 6.5MM and 8.0MM Cannulated Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HWC Screw, Fixation, Bone
Cleared on Apr 18, 2006 as substantially equivalent to K993106 (Smith & Nephew, Inc., 1999) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1990. 1 of the 537 devices in its family, counting itself, has a Class I recall. 531 later devices descend from it. It has been recalled once.
- Decided
- Apr 18, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K903810 (1990). 5 ancestors in all. 531 later devices descend from it, 10 citing it directly. 1 of the 537 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 1 generation backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- This deviceK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 2 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 93 of its ownK072818 Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe…Smith & Nephew, Inc. · 2007
Showing 5 of 531 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 531 · See all- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · cites it directly487descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 2 generations on228descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 2 generations on161descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 3 generations on118descendants
- K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc. · 2007 · cites it directly93descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −1 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| 0 (this device) | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | Smith & Nephew, Inc. | 2006 | — |
| +1 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +2 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +3 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | Smith & Nephew, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 11 | 0 |
| 2013 | 8 | 0 |
| 2014 | 23 | 0 |
| 2015 | 26 | 0 |
| 2016 | 16 | 0 |
| 2017 | 39 | 0 |
| 2018 | 24 | 0 |
| 2019 | 29 | 0 |
| 2020 | 36 | 0 |
| 2021 | 44 | 1 |
| 2022 | 35 | 0 |
| 2023 | 45 | 0 |
| 2024 | 61 | 0 |
| 2025 | 51 | 0 |
| 2026 | 67 | 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.
1 device in this family has a Class I recall. 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 1…n indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: K993106, Smith & Nephew Bone Plate System; K903810, Ace Medical Cannulated Screw; K000080, Howmedica Osteonics ASNIS III Cannulated Screw… | 1999 |
| * | K903810 | Ace Cannulated Self Tapping Cancellous Bone ScrewSummary page 1…rational principles, and material composition when compared to the predicate devices cleared under the following submissions: K993106, Smith & Nephew Bone Plate System; K903810, Ace Medical Cannulated Screw; K000080, Howmedica Osteonics ASNIS III Cannulated Screw System; and KO0i1296, DePuy Spine Inc. SIJ… | 1990 |
| * | K000080 | Asnis Iii Cannulated Screw SystemSummary page 1…sition when compared to the predicate devices cleared under the following submissions: K993106, Smith & Nephew Bone Plate System; K903810, Ace Medical Cannulated Screw; K000080, Howmedica Osteonics ASNIS III Cannulated Screw System; and KO0i1296, DePuy Spine Inc. SIJF Cannulated Screw System.… | 2000 |
| * | K051296 | Sijf Cannulated Screw System Our reading of the summary gave K001296, FDA’s number for Spinal Cord and Immobilization Traction System (Cavendish Scott, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DePuy Spine Inc. SIJF Cannulated Screw System”. | 2005 |
What descends from it? (531)
See all 53110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | 2009 | 487 |
| K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access | 2007 | 93 |
| K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System | 2014 | 46 |
| K124027 | Monster Screw System | 2013 | 41 |
| K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | 2013 | 33 |
| K080649 | Pogo Screw | 2008 | 15 |
| K093676 | Omnitech Large, Trimed Compression Screw | 2010 | 13 |
| 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2021 | Class II | Z-0143-2022 | Process control | The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K090675 (Smith & Nephew, Inc., 2009) has gone furthest, with 487 descendants of its own.
- 35 other devices also cite its predicate K993106.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Smith & Nephew Bone Plate System is 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 calcaneal; hip arthrodesis, and provisional bone fixation.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are for single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060736 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060736: Smith & Nephew 6.5MM and 8.0MM Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060736
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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