510(k) · Cleared
ClearedActivOrtho Nitinol Compression Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Activortho, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 12, 2019 as substantially equivalent to K160427 (Mx Orthopedics, Corp., 2016) and 3 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Mar 12, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K962011 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK962011 Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa) · 1996
- 1 generation backK102903 Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc. · 2010
- This deviceK181610 ActivOrtho Nitinol Compression Screw SystemActivortho, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191817 ActivOrtho Continuous Compression Screw SystemActivortho, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962011 | Synthes 7.0/7.3 MM Cannulated Screws | Synthes (Usa) | 1996 | — |
| −1 | K102903 | Pioneer Cannulated Screw System | Pioneer Surgical Technology, Inc. | 2010 | — |
| 0 (this device) | K181610 | ActivOrtho Nitinol Compression Screw System | Activortho, Inc. | 2019 | — |
| +1 | K191817 | ActivOrtho Continuous Compression Screw System | Activortho, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (4)
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 |
|---|---|---|---|
| * | K160427 | dynaMX (TM) Nitinol Compression ScrewSummary page 4…made from Nitinol (ASTM F2063). Primary Predicate: dynaMX™ Nitinol Compression Screw (MX Orthopedics Corporation -- K160427) Additional Synthes 4.0 Cannulated Screw (Synthes USA – K963192); Vilex Predicates: Cannulated Bone Scre… | 2016 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 4…dynaMX™ Nitinol Compression Screw (MX Orthopedics Corporation -- K160427) Additional Synthes 4.0 Cannulated Screw (Synthes USA – K963192); Vilex Predicates: Cannulated Bone Screw (Vilex Inc. – K973309), Zimmer Cannulated Screw Sys… | 1996 |
| * | K973309 | Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewSummary page 4…K160427) Additional Synthes 4.0 Cannulated Screw (Synthes USA – K963192); Vilex Predicates: Cannulated Bone Screw (Vilex Inc. – K973309), Zimmer Cannulated Screw System (Pioneer Surgical Technology – K102903) Performance Data: Torsiona… | 1998 |
| * | K102903 | Pioneer Cannulated Screw SystemSummary page 4…63192); Vilex Predicates: Cannulated Bone Screw (Vilex Inc. – K973309), Zimmer Cannulated Screw System (Pioneer Surgical Technology – K102903) Performance Data: Torsional properties, driving torque and axial pullout strength testing was perf… | 2010 |
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 |
|---|---|---|---|
| K191817 | ActivOrtho Continuous Compression Screw System | 2019 | 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 23 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K191817 (Activortho, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160427.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 ActivOrtho Nitinol Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181610: ActivOrtho Nitinol Compression 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/K181610
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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