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 May 1, 2017 as substantially equivalent to K143039 (Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem, 2015) and 2 other predicates after a 206-day review. Its family tree reaches back 11 generations to 1996. 1 of the 167 devices in its family, counting itself, has a Class I recall. 74 later devices descend from it.
- Decided
- May 1, 2017
- Review
- 206 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K962616 (1996). 92 ancestors in all, the oldest K792022 (1979). 74 later devices descend from it, 3 citing it directly. 1 of the 167 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 1 generation backK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- This deviceK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · 3 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · 2 generations on · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 1 generation backK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- This deviceK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub2 generations on · 2021
Most influential descendants
Showing 5 of 74 · See all- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · cites it directly69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 2 generations on42descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 3 generations on23descendants
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on9descendants
- K220862E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −1 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| 0 (this device) | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +1 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +2 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +3 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +2 | K211616 | ExcelsiusHub | Globus Medical, Inc. | 2021 | Class I |
| +2 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 1 |
| 2022 | 7 | 0 |
| 2023 | 9 | 0 |
| 2024 | 15 | 0 |
| 2025 | 15 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | K143039 | CrossRoads Screw SystemSummary page 4…ic bone fixation fastener Product Code: HWC Regulatory Class: II Primary Predicate: CrossRoads Screws (K143039) Additional Smith & Nephew Cannulated Screws (K111994) Predicates: Synthes 1.5mm Headless Compression Screws (K… | 2015 |
| * | K111994 | Smith & Nephew Cannulated Screws and WashersSummary page 4…Product Code: HWC Regulatory Class: II Primary Predicate: CrossRoads Screws (K143039) Additional Smith & Nephew Cannulated Screws (K111994) Predicates: Synthes 1.5mm Headless Compression Screws (K090949) Reference ZYFUSE® Facet Fixation Screws (K090… | 2011 |
| * | K090949 | Synthes (Usa) 1.5MM Headless Compression ScrewsSummary page 4…ary Predicate: CrossRoads Screws (K143039) Additional Smith & Nephew Cannulated Screws (K111994) Predicates: Synthes 1.5mm Headless Compression Screws (K090949) Reference ZYFUSE® Facet Fixation Screws (K090952) Devices: Skeletal Dynamics Geminus Screws (K122737)… | 2009 |
| † | K090952 | Zyfuse Facet Fixation System | 2009 |
| † | K122737 | Geminus Fossa Specific Plate System | 2012 |
| † | K021932 | Synthes 6.5 MM Cannulated Screw | 2002 |
What descends from it? (74)
See all 743 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 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 92 ancestors have a recall of any class.
- Of its descendants, K171651 (Globus Medical, Inc., 2017) has gone furthest, with 69 descendants of its own.
- 2 other devices also cite its predicate K143039.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 as stated in the FDA summary.
https://510kreport.com/device/K162825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162825: CAPTIVATE™ Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162825
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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