510(k) · Cleared
ClearedCAPTIVATE® Compression Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · HWC Screw, Fixation, Bone
Cleared on Sep 8, 2022 as substantially equivalent to K162825 (Globus Medical, Inc., 2017) and 2 other predicates after a 29-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it.
- Decided
- Sep 8, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K962616 (1996). 144 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 2 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 1 generation backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- This deviceK222409 CAPTIVATE® Compression ScrewsGlobus Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230946 Accelerate Compression Screw System-Small Product Code ACC-S…Trax Surgical · 2023
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 4 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 3 generations backK151418 Monster Screw SystemParagon 28 · 2015
- 2 generations backK153378 Monster BITE Screw SystemParagon 28 · 2015
- 1 generation backK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- This deviceK222409 CAPTIVATE® Compression ScrewsGlobus Medical, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −4 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −3 | K151418 | Monster Screw System | Paragon 28 | 2015 | — |
| −2 | K153378 | Monster BITE Screw System | Paragon 28 | 2015 | — |
| −1 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| 0 (this device) | K222409 | CAPTIVATE® Compression Screws | Globus Medical, Inc. | 2022 | — |
| +1 | K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate… | Trax Surgical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K162825 | CAPTIVATE™ Compression ScrewsSummary page 4…n fastener Product Code: HWC Regulatory Class: II Primary Predicate: CAPTIVATE® Compression Screws (K162825) Other Predicates: Zimmer Biomet Cannulated Screw System (K140891) Paragon 28 Monster® Screw System (K190586)… | 2017 |
| * | K140891 | Biomet Cannulated Screw SystemSummary page 4…Code: HWC Regulatory Class: II Primary Predicate: CAPTIVATE® Compression Screws (K162825) Other Predicates: Zimmer Biomet Cannulated Screw System (K140891) Paragon 28 Monster® Screw System (K190586) Reference Device: ANTHEM® Fracture System (K212433) Purpose: The… | 2014 |
| * | K190586 | Monster® Screw SystemSummary page 4…Predicate: CAPTIVATE® Compression Screws (K162825) Other Predicates: Zimmer Biomet Cannulated Screw System (K140891) Paragon 28 Monster® Screw System (K190586) Reference Device: ANTHEM® Fracture System (K212433) Purpose: The purpose of this submission is to request clearance for new im… | 2019 |
| † | K212433 | Anthem Fracture System | 2021 |
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 |
|---|---|---|---|
| K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression… | 2023 | 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 26 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 29 of the 144 ancestors have a recall of any class.
- Of its descendants, K230946 (Trax Surgical, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K162825.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
CAPTIVATE® Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CAPTIVATE® VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.
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/K222409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222409: CAPTIVATE® Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222409
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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