510(k) · Cleared
ClearedSmith & Nephew Cannulated Captured Screw
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 May 15, 2014 as substantially equivalent to K103705 (Arthrex, Inc., 2011) after a 167-day review. Its family tree reaches back 7 generations to 2000. 8 later devices descend from it.
- Decided
- May 15, 2014
- Review
- 167 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000684 (2000). 29 ancestors in all, the oldest K890939 (1989). 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 3 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 2 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 1 generation backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- This deviceK133662 Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253713 Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · cites it directly7descendants
- 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 · 2 generations on1descendant
- K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · 3 generations on0descendants
- K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −3 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −2 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −1 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K133662 | Smith & Nephew Cannulated Captured Screw | Smith & Nephew, Inc. | 2014 | — |
| +1 | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | 1 |
| +1 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
| +3 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | — |
| +2 | K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 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? (1)
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 |
|---|---|---|---|
| * | K103705 | Low Profile ScrewsSummary page 2…Submission Clearance Mauacue Decito Numbe Date IArthrex, Inc. Low Profile Screws K103705 3/18/2011 Conclusion As previously noted, this Traditional 510(k) Premarket Notification isbeing submitted to request clea… | 2011 |
What descends from it? (8)
2 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 14 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 29 ancestors have a recall of any class.
- Of its descendants, K210837 (Smith & Nephew, Inc., 2021) has gone furthest, with 7 descendants of its own.
- 21 other devices also cite its predicate K103705.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Smith & Nephew Cannulated Captured Screw IsIntended for use for Internal bone fixation including fractures of the tibia, fibula, clavicle, scapula, olecranon, metacarpals, metatarsals, humerus, ulna, middle hand bones, middle foot bones, end calcaneous. Screws are additionally Intended for arthrodeses and osteotomles of small bones and small joints including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, clavicle, scapula, olecranon, ulnar stylold, radial head, and radial stylid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133662: Smith & Nephew Cannulated Captured Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133662
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