510(k) · Cleared
Cleared4.0 and 6.5 Cancellous Bone Screw and Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smv Scientific · HWC Screw, Fixation, Bone
Cleared on Dec 5, 2016 as substantially equivalent to K111994 (Smith & Nephew, Inc., 2011) and 4 other predicates after a 244-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.
- Decided
- Dec 5, 2016
- Review
- 244 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K962616 (1996). 69 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- This deviceK160946 4.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific · 2016
- Descendant · cites it directly · 0 of its ownK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026
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 backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- This deviceK160946 4.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific · 2016
Most influential descendants
Showing 1 of 1 · See all- K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026 · cites it directly0descendants
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 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K160946 | 4.0 and 6.5 Cancellous Bone Screw and Washer | Smv Scientific | 2016 | — |
| +1 | K260277 | Mikron Trauma Bone Plate& Screw System | Mikron Makina San. ve Tic. Ltd. Sti. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 HWC? 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? (5)
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 |
|---|---|---|---|
| * | K111994 | Smith & Nephew Cannulated Screws and WashersSummary page 5…at of the predicate devices listed in Table 5-1. Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Type K111994 4.0 Cannulated Screws Smith & Nephew Primary K000089 4.0mm and 5.0mm Locking… | 2011 |
| * | K000089 | Synthes 4.0 and 5.0 MM Locking ScrewsSummary page 5…Trade or Proprietary or Model Name Manufacturer Type K111994 4.0 Cannulated Screws Smith & Nephew Primary K000089 4.0mm and 5.0mm Locking Screws Synthes Additional K963192 3.5mm and 4.0mm Cannulat… | 2000 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 5…4.0 Cannulated Screws Smith & Nephew Primary K000089 4.0mm and 5.0mm Locking Screws Synthes Additional K963192 3.5mm and 4.0mm Cannulated Screws Synthes Additional K061621 6.5mm Cancellous S… | 1996 |
| * | K061621 | Synthes (Usa) 6.5 MM Cancellous ScrewsSummary page 5…4.0mm and 5.0mm Locking Screws Synthes Additional K963192 3.5mm and 4.0mm Cannulated Screws Synthes Additional K061621 6.5mm Cancellous Screw Synthes Additional K052483 Spherical Washe… | 2006 |
| * | K052483 | Synthes (Usa) Spherical WashersSummary page 5…3.5mm and 4.0mm Cannulated Screws Synthes Additional K061621 6.5mm Cancellous Screw Synthes Additional K052483 Spherical Washers Synthes Additional PERFORMANCE DATA The SMV Scientific 4.0 and… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260277 | Mikron Trauma Bone Plate& Screw System | 2026 | 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 20 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 15 of the 69 ancestors have a recall of any class.
- Of its descendants, K260277 (Mikron Makina San. ve Tic. Ltd. Sti., 2026) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K111994.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g.: – tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies – tarsometatarsal and metatarsophalangeal arthrodeses – ligament fixations – hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small bones and small joints…
Read the full statement (156 words)
The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g.: – tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies – tarsometatarsal and metatarsophalangeal arthrodeses – ligament fixations – hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is 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 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: – femoral neck fractures – intercondylar femoral fractures – epiphyseolysis of the femoral head – ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160946: 4.0 and 6.5 Cancellous Bone Screw and Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160946
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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