510(k) · Cleared
Recalled · 2010CSS Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 7, 2006 as substantially equivalent to K000080 (Howmedica Osteonics Corp., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 46 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 7, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000080 (2000). 46 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK000080 Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2000 · Recalled
- This deviceK060428 CSS Cannulated Screw SystemOrthohelix Surgical Designs, Inc. · 2006
- Descendant · cites it directly · 41 of its ownK124027 Monster Screw SystemApogee Orthosolutions · 2013
- Descendant · 2 generations on · 27 of its ownK151418 Monster Screw SystemParagon 28 · 2015
- Descendant · 3 generations on · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
- Descendant · 3 generations on · 22 of its ownK153378 Monster BITE Screw SystemParagon 28 · 2015
- Descendant · 2 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K124027Monster Screw SystemApogee Orthosolutions · 2013 · cites it directly41descendants
- K151418Monster Screw SystemParagon 28 · 2015 · 2 generations on27descendants
- K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017 · 3 generations on24descendants
- K153378Monster BITE Screw SystemParagon 28 · 2015 · 3 generations on22descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000080 | Asnis Iii Cannulated Screw System | Howmedica Osteonics Corp. | 2000 | 1 |
| 0 (this device) | K060428 | CSS Cannulated Screw System | Orthohelix Surgical Designs, Inc. | 2006 | — |
| +1 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| +2 | K151418 | Monster Screw System | Paragon 28 | 2015 | — |
| +3 | K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | Extremity Medical, LLC | 2017 | — |
| +3 | K153378 | Monster BITE Screw System | Paragon 28 | 2015 | — |
| +2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K000080 | Asnis Iii Cannulated Screw SystemSummary page 1…e Screw, Fixation, Bone Single/Multiple Component Metallic Fixation Appliances and Accessories Predicate Devices Howmedica Asnis Ill Cannulated Screw System (K000080) Intended Use The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fix… | 2000 |
What descends from it? (46)
See all 464 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2010 | Not classified | Z-0466-2011 | Device Design | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual… |
| Oct 15, 2010 | Not classified | Z-0467-2011 | Device Design | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual… |
| Oct 15, 2010 | Not classified | Z-0468-2011 | Device Design | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual… |
| Apr 7, 2009 | Not classified | Z-1250-2010 | Other | A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following;
* Fractures of the tarsals and metatarsals
* Fractures of the olecranon, distal humerous
* Fractures of the radius and ulna
* Patella fractures
* Distal tibia and pilon fractures
* Fractures of the fibula, medial malleolus, os calcis
* Tarso-metatarsal and metatarsal phalangeal arthrodesis
* Metatarsal and phalangeal osteotomies
* Osteochondritis dissecans
* Ligament fixation
* Other small fragment, cancellous bone fractures and osteotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060428: CSS Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060428
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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