510(k) · Cleared
ClearedKompressor Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetikos Medical, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 1, 2004 as substantially equivalent to K024233 (Kinetikos Medical, Inc., 2003) after a 17-day review. Its family tree reaches back 3 generations to 1996. 1 of the 264 devices in its family, counting itself, has a Class I recall. 255 later devices descend from it.
- Decided
- Mar 1, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962823 (1996). 8 ancestors in all, the oldest K792022 (1979). 255 later devices descend from it, 3 citing it directly. 1 of the 264 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 2 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 1 generation backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- This deviceK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- Descendant · cites it directly · 251 of its ownK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- Descendant · 2 generations on · 246 of its ownK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- Descendant · 3 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 4 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 4 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
Showing 5 of 255 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 255 · See all- K060071Nexa Compression ScrewNexa Orthopedics, Inc. · 2006 · cites it directly251descendants
- K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007 · 2 generations on246descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 3 generations on161descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 4 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 4 generations on74descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −2 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −1 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| 0 (this device) | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| +1 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| +2 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| +3 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +4 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +4 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 7 | 0 |
| 2015 | 14 | 0 |
| 2016 | 7 | 0 |
| 2017 | 17 | 0 |
| 2018 | 5 | 0 |
| 2019 | 10 | 0 |
| 2020 | 15 | 0 |
| 2021 | 19 | 1 |
| 2022 | 21 | 0 |
| 2023 | 23 | 0 |
| 2024 | 28 | 0 |
| 2025 | 27 | 0 |
| 2026 | 36 | 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 22.3 · 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 |
|---|---|---|---|
| * | K024233 | Kompressor Screw SystemSummary page 1…Name: Orthopedic 3. Predicate or legally marketed devices which are substantially equivalent -KMl Kompressor compression screw (K024233) 4. Description of Device… | 2003 |
What descends from it? (255)
See all 2553 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K060071 (Nexa Orthopedics, Inc., 2006) has gone furthest, with 251 descendants of its own.
- 2 other devices also cite its predicate K024233.
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 use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including:
: Infection
: Metal sensitivity or allergic reaction to foreign bodies
: Any concomitant disease which may compromise the function of the implant
* In those cases where avascular necrosis has rendered bone stock inadequate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040356 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040356: Kompressor Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040356
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