510(k) · Cleared
ClearedGEO Bone Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gramercy Extremity Orthopedics, LLC · HWC Screw, Fixation, Bone
Cleared on Oct 22, 2020 as substantially equivalent to K161904 (Gramercy Extremity Orthopeidics, LLC, 2017) and 4 other predicates after a 28-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it.
- Decided
- Oct 22, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K962616 (1996). 209 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 deviceK202817 GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020
- 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 deviceK202817 GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC · 2020
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) | K202817 | GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC | 2020 | — |
| +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 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 10 | 0 |
| 1996 | 18 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 10 | 0 |
| 2000 | 8 | 0 |
| 2001 | 14 | 0 |
| 2002 | 10 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 16 | 0 |
| 2006 | 13 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K161904 | GEO Bone Screw SystemSummary page 4…Richardson, TX 75081 Date Prepared: August 31, 2020 Trade Name: GEO Bone Screw System Primary Predicate Device (self): K161904 GEO Bone Screw System Additional Predicate Devices: K153154 Stryker Asnis JFX System, K190686 Predicate… | 2017 |
| * | K153154 | Asnis JFX SystemSummary page 4…GEO Bone Screw System Primary Predicate Device (self): K161904 GEO Bone Screw System Additional Predicate Devices: K153154 Stryker Asnis JFX System, K190686 Predicate Paragon 28 Monster Screw System, K191289 Vilex Bone Screw Lin… | 2015 |
| * | K190586 | Monster® Screw System Our reading of the summary gave K190686, FDA’s number for Optilite IgM CSF Kit (The Binding Site Group, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Paragon 28 Monster Screw System”. | 2019 |
| * | K191289 | Bone Screw Line AdditionSummary page 4…System Additional Predicate Devices: K153154 Stryker Asnis JFX System, K190686 Predicate Paragon 28 Monster Screw System, K191289 Vilex Bone Screw Line Addition, K180377 In2Bones Fracture and Correction System Common Names F… | 2019 |
| * | K180377 | Fracture and Correction SystemSummary page 4…3154 Stryker Asnis JFX System, K190686 Predicate Paragon 28 Monster Screw System, K191289 Vilex Bone Screw Line Addition, K180377 In2Bones Fracture and Correction System Common Names Fixation, bone screw Washer, Bolt Nut Classificati… | 2018 |
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 24 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 43 of the 209 ancestors have a recall of any class.
- Of its descendants, K230946 (Trax Surgical, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161904.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202817: GEO Bone 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/K202817
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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