510(k) · Cleared
ClearedNexa Compression Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexa Orthopedics, Inc. · HWC Screw, Fixation, Bone
Cleared on Jan 26, 2006 as substantially equivalent to K043281 (Wrightmedicaltechnologyinc, 2005) and 2 other predicates after a 17-day review. Its family tree reaches back 4 generations to 1996. 1 of the 263 devices in its family, counting itself, has a Class I recall. 251 later devices descend from it.
- Decided
- Jan 26, 2006
- Review
- 17 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K962823 (1996). 11 ancestors in all, the oldest K792022 (1979). 251 later devices descend from it, 2 citing it directly. 1 of the 263 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 3 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 2 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 1 generation backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- This deviceK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- Descendant · cites it directly · 246 of its ownK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- Descendant · 2 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 3 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 4 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
Showing 5 of 251 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 251 · See all- K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007 · cites it directly246descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 2 generations on161descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 3 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 3 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 4 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −3 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −2 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −1 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| 0 (this device) | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| +1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| +2 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +3 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +3 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +4 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
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 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 5 | 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 22.2 · 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? (3)
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 |
|---|---|---|---|
| * | K043281 | Charlotte High-Demand Compression ScrewSummary page 1…: Class II Reviewing Panel: Orthopedic Regulation Number 888.3040 Product Code: 87 HWC Predicate Devices: K043281, Wright Medical Charlotte High-Demand Compression Screw; K043102, Wright Medical Charlotte… | 2005 |
| * | K043102 | Multi-Use Compression ScrewSummary page 1…3040 Product Code: 87 HWC Predicate Devices: K043281, Wright Medical Charlotte High-Demand Compression Screw; K043102, Wright Medical Charlotte Multi-Use Compression Screw; and K040356… | 2005 |
| * | K040356 | Kompressor Screw SystemSummary page 1…Compression Screw; K043102, Wright Medical Charlotte Multi-Use Compression Screw; and K040356 KMI Kompressor Compression Screw System Registration Number: 2030833 Owner Operator Number: 9028319 Device De… | 2004 |
What descends from it? (251)
See all 2512 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K063298 (Osteomed LP, 2007) has gone furthest, with 246 descendants of its own.
- 1 other device also cites its predicate K043281.
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 Nexa Compression Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060071: Nexa Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060071
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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